Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00527735

Enrollment

334

Registered

2007-09-11

Start date

2008-02-29

Completion date

2011-12-31

Last updated

2018-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung, Lung Cancer, Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC)

Brief summary

The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.

Interventions

DRUGIpilimumab

Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.

DRUGPlacebo

Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.

DRUGPaclitaxel

175 mg/m\^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.

DRUGCarboplatin

Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer \[SCLC\]) * Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria * Eastern Cooperative Oncology Group performance status of ≤1 at study entry * Accessible for treatment and follow-up

Exclusion criteria

* Brain metastases * Malignant pleural effusion * Autoimmune disease * Motor neuropathy of autoimmune origin * SCLC-related paraneoplastic syndromes * Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study) * Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed. * Grade 2 peripheral neuropathy (motor or sensory) * Known HIV or hepatitis B or C infection * Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies. * Inadequate hematologic function defined by an absolute neutrophil count \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or hemoglobin level \<9 g/dL. * Inadequate hepatic function defined by a total bilirubin level \>2.0 times the upper limit of normal (ULN), or ≥2.5 times the ULN if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the ULN or ≥5 times the ULN if liver metastases are present. * Inadequate renal function defined by a serum creatinine level ≥2.5 times the ULN * Inadequate creatinine clearance defined as less than 50 mL/min.

Design outcomes

Primary

Measure	Time frame	Description
Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)	Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)	irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.

Secondary

Measure	Time frame	Description
Overall Survival in Participants With NSCLC	Randomization date to date of death (of censored, maximum reached: 26.5 months)	Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.
Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC	Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance	mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage). CR=Complete disappearance of all index lesions; PR=decrease from baseline of \>=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions. Independent review committee performed tumor assessment.
Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)	Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance	irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set. irCR=Complete disappearance of all index lesions. irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions. Independent review committee performed the tumor assessments.
Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC	Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)	irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set. irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease. By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set. SD=A decrease or tumor stabilization of 1 or more nonindex lesions. Independent review committee assessed response.
Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC	Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)	irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first. For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment. By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first. For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent	CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:\<LLN to 3.0\10\^9/L, Gr 2:\<3.0 to 2.0\10\^9/L, Gr 3:\<2.0 to 1.0\10\^9/L, Gr 4:\<1.0\10\^9/L. ANC Gr 1:\<LLN to 1.5\10\^9/L, Gr 2:\<1.5 to 1.0\10\^9/L, Gr 3:\<1.0 to 0.5\10\^9/L, Gr 4:\<0.5\10\^9/L. Platelet count Gr 1:LLN to 75.0\10\^9/L, Gr 2:\<75.0 to 50.0\10\^9/L, Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Hemoglobin Gr 1:\<LLN to 10.0 g/dL, Gr 2:\<10.0 to 8.0 g/dL, Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL.
irPFS in Participants With SCLC Per irRC	Randomization date to date of irPD or death (maximum reached: 22 months)	IRC performed TA.
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent	ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. CTC grade criteria: ALT Grade 1:\>ULN to 2.5\ULN; Grade 2: \>2.5 to 5.0\ULN; Grade 3: \>5.0 to 20.0\ULN; Grade 4: \>20.0\ULN. AST Grade 1: \>ULN to 2.5\ULN; Grade 2: \>2.5 to 5.0\ULN; Grade 3: \>5.0 to 20.0\ULN; Grade 4: \>20.0\ULN. Total bilirubin Grade 1: \>ULN to 1.5\ULN; Grade 2: \>1.5 to 3.0\ULN; Grade 3: \>3.0 to 10.0\ULN; Grade 4: \>10.0\ULN. ALK (U/L) G1:\>ULN to 2.5\ULN, G2:\>2.5 to 5.0\ULN, G3:\>5.0 to 20.0\ULN, G4:\>20.0\ULN.
Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent	Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.
Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria	Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)	By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.
Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline	Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment	An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment	CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:\<LLN to 3.0\10\^9/L, Gr 2:\<3.0 to 2.0\10\^9/L, Gr 3:\<2.0 to 1.0\10\^9/L, Gr 4:\<1.0\10\^9/L. ANC Gr 1:\<LLN to 1.5\10\^9/L, Gr 2:\<1.5 to 1.0\10\^9/L, Gr 3:\<1.0 to 0.5\10\^9/L, Gr 4:\<0.5\10\^9/L. Platelet count Gr 1:LLN to 75.0\10\^9/L, Gr 2:\<75.0 to 50.0\10\^9/L, Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Hemoglobin Gr 1:\<LLN to 10.0 g/dL, Gr 2:\<10.0 to 8.0 g/dL, Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL.
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment	ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. ULN=Upper limit of normal among all laboratory ranges. CTC grade criteria: ALT Grade 1:\>ULN to 2.5\ULN; Grade 2: \>2.5 to 5.0\ULN; Grade 3: \>5.0 to 20.0\ULN; Grade 4: \>20.0\ULN. AST Grade 1: \>ULN to 2.5\ULN; Grade 2: \>2.5 to 5.0\ULN; Grade 3: \>5.0 to 20.0\ULN; Grade 4: \>20.0\ULN. Total bilirubin Grade 1: \>ULN to 1.5\ULN; Grade 2: \>1.5 to 3.0\ULN; Grade 3: \>3.0 to 10.0\ULN; Grade 4: \>10.0\ULN. ALK (U/L) G1:\>ULN to 2.5\ULN, G2:\>2.5 to 5.0\ULN, G3:\>5.0 to 20.0\ULN, G4:\>20.0\ULN.
Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade	At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment	ULN=upper limit of normal. Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39\ULN; Gr 2: \>1.5 to 2.0\ULN; Gr 3: 2.5 to 5; Gr 4: 5\ULN. Amylase (U/L) Gr 1: \>ULN to 1.5\ULN; Gr 2 \>1.5 to 2.0\ULN, Gr 3 \>2.0 to 5.0\ULN, Gr 4 \>5.0\ULN. Creatine (mg/dL) Gr 1: \>ULN to 1.5\ULN, Gr 2: 1.5 to 3.0\ULN, Gr 3: \>3.0 to 6.0\ULN, Gr 4: \>6.0\*ULN.
Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria	Randomization date to date of progression or death (of censored, maximum reached: 22 months)	By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.
Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment	Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.
Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline	Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment	An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.
Overall Survival in Participants With SCLC	Randomization date to date of death (of censored, maximum reached: 22 months)	Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.
Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade	At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment	ULN=upper limit of normal. Lipase (U/L) Gr 1: 1.1 to 1.39\ULN; Gr 2: \>1.5 to 2.0\ULN; Gr 3: 2.5 to 5; Gr 4: 5\ULN. Amylase (U/L) Gr 1: \>ULN to 1.5\ULN; Grade 2 \>1.5 to 2.0\ULN, Grade 3 \>2.0 to 5.0\ULN, Grade 4 \>5.0\ULN. Creatine (mg/dL) Grade 1: \>ULN to 1.5\ULN, Gr 2: 1.5 to 3.0\ULN, Gr 3: \>3.0 to 6.0\ULN, Gr 4: \>6.0\*ULN.

Countries

France, Germany, India, Italy, Poland, Russia, Ukraine, United States

Participant flow

Pre-assignment details

Of 334 participants enrolled in this study, 331 received treatment. One patient with nonsmall-cell lung cancer, randomized to the sequential arm but mistakenly treated with concurrent therapy, is included in the sequential arm for efficacy results and in the concurrent arm for safety results.

Participants by arm

Arm	Count
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	113
Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	110
Placebo + Paclitaxel/Carboplatin During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who experienced clinical benefit on treatment phase without intolerable toxicity could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.	111
Total	334

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	10	6	7
Overall Study	Completed treatment during maintenance	2	2	1
Overall Study	Completed treatment in treatment phase	14	13	18
Overall Study	Death	23	13	15
Overall Study	Disease progression	47	61	53
Overall Study	Lost to Follow-up	0	0	3
Overall Study	No longer met study criteria	2	2	1
Overall Study	Not identified	5	5	5
Overall Study	Poor compliance or noncompliance	0	1	1
Overall Study	Withdrawal by Subject	5	4	3

Baseline characteristics

Characteristic	Total	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Placebo + Paclitaxel/Carboplatin
Age, Customized 65 years and older	106 Participants	34 Participants	37 Participants	35 Participants
Age, Customized Younger than 65 years	228 Participants	79 Participants	73 Participants	76 Participants
Age Customized, by Disease Type 65 years and older (NSCLC patients)	76 Participants	26 Participants	24 Participants	26 Participants
Age Customized, by Disease Type 65 years and older (SCLC patients)	30 Participants	8 Participants	13 Participants	9 Participants
Age Customized, by Disease Type Younger than 65 years (NSCLC patients)	128 Participants	44 Participants	44 Participants	40 Participants
Age Customized, by Disease Type Younger than 65 years (SCLC patients)	100 Participants	35 Participants	29 Participants	36 Participants
Cell Type Adenocarcinoma (NSCLC patients)	103 Participants	35 Participants	30 Participants	38 Participants
Cell Type Bronchoalveolar carcinoma (NSCLC patients)	2 Participants	1 Participants	1 Participants	0 Participants
Cell Type Large-cell carcinoma (NSCLC patients)	24 Participants	6 Participants	11 Participants	7 Participants
Cell Type Not reported (SCLC patients)	1 Participants	0 Participants	1 Participants	0 Participants
Cell Type Other (NSCLC patients)	13 Participants	6 Participants	4 Participants	3 Participants
Cell Type Other (SCLC patients)	4 Participants	2 Participants	2 Participants	0 Participants
Cell Type Small-cell carcinoma (SCLC patients)	124 Participants	41 Participants	38 Participants	45 Participants
Cell Type Squamous-cell carcinoma (NSCLC patients)	57 Participants	21 Participants	21 Participants	15 Participants
Cell Type Unknown (NSCLC patients)	5 Participants	1 Participants	1 Participants	3 Participants
Cell Type Unknown (SCLC patients)	1 Participants	0 Participants	1 Participants	0 Participants
Disease Stage at Study Entry Extensive (SCLC patients)	129 Participants	43 Participants	42 Participants	44 Participants
Disease Stage at Study Entry Recurrent disease (SCLC patients)	1 Participants	0 Participants	0 Participants	1 Participants
Disease Stage at Study Entry Stage IIIB (NSCLC patients)	35 Participants	11 Participants	7 Participants	17 Participants
Disease Stage at Study Entry Stage IV (NSCLC patients)	169 Participants	59 Participants	61 Participants	49 Participants
Gender, by Disease Type Female (NSCLC patients)	53 Participants	17 Participants	19 Participants	17 Participants
Gender, by Disease Type Female (SCLC patients)	32 Participants	10 Participants	10 Participants	12 Participants
Gender, by Disease Type Male (NSCLC patients)	151 Participants	53 Participants	49 Participants	49 Participants
Gender, by Disease Type Male (SCLC patients)	98 Participants	33 Participants	32 Participants	33 Participants
Sex: Female, Male Female	85 Participants	27 Participants	29 Participants	29 Participants
Sex: Female, Male Male	249 Participants	86 Participants	81 Participants	82 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	63 / 71	63 / 67	59 / 65	36 / 42	39 / 42	41 / 44
serious Total, serious adverse events	49 / 71	36 / 67	33 / 65	25 / 42	21 / 42	20 / 44

Outcome results

Primary

Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)

irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.

Time frame: Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)

Population: All participants with NSCLC who were randomized to a treatment group.

Arm	Measure	Value (MEDIAN)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)	5.52 Months
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)	5.68 Months
Placebo + Paclitaxel/Carboplatin	Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)	4.63 Months

p-value: 0.130295% CI: [0.553, 1.174]1-sided log rank

p-value: 0.047395% CI: [0.495, 1.059]1-sided log rank

Secondary

Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC

mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage). CR=Complete disappearance of all index lesions; PR=decrease from baseline of \>=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions. Independent review committee performed tumor assessment.

Time frame: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance

Population: All participants who were randomized to a treatment group.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC	BORR (mWHO criteria) NSCLC cohort (n=70, 68, 66)	21.4 Percentage of participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC	BORR (mWHO criteria) SCLC cohort (n=43, 42, 45)	32.6 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC	BORR (mWHO criteria) SCLC cohort (n=43, 42, 45)	57.1 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC	BORR (mWHO criteria) NSCLC cohort (n=70, 68, 66)	32.4 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC	BORR (mWHO criteria) NSCLC cohort (n=70, 68, 66)	13.6 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC	BORR (mWHO criteria) SCLC cohort (n=43, 42, 45)	48.9 Percentage of participants

Secondary

Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)

irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set. irCR=Complete disappearance of all index lesions. irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions. Independent review committee performed the tumor assessments.

Time frame: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance

Population: All participants who were randomized to a treatment group.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)	irBORR (irRC) SCLC cohort (n=43, 42, 45)	48.8 Percentage of participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)	irBORR ( irRC) NSCLC cohort (n=70, 68, 66)	21.4 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)	irBORR (irRC) SCLC cohort (n=43, 42, 45)	71.4 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)	irBORR ( irRC) NSCLC cohort (n=70, 68, 66)	32.4 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)	irBORR ( irRC) NSCLC cohort (n=70, 68, 66)	18.2 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)	irBORR (irRC) SCLC cohort (n=43, 42, 45)	53.3 Percentage of participants

Secondary

Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC

irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set. irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease. By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set. SD=A decrease or tumor stabilization of 1 or more nonindex lesions. Independent review committee assessed response.

Time frame: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)

Population: All participants who were randomized to a treatment group.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC	irDCR (irRC) NSCLC cohort (n=70, 68, 66)	70.0 Percent of participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC	rDCR (irRC) SCLC cohort (n=43, 42, 45)	81.4 Percent of participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC	DCR (mWHO criteria) SCLC cohort (n=43, 42, 45)	69.8 Percent of participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC	DCR (mWHO criteria) NSCLC cohort (n=70, 68, 66)	57.1 Percent of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC	DCR (mWHO criteria) SCLC cohort (n=43, 42, 45)	81.0 Percent of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC	irDCR (irRC) NSCLC cohort (n=70, 68, 66)	86.8 Percent of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC	DCR (mWHO criteria) NSCLC cohort (n=70, 68, 66)	77.9 Percent of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC	rDCR (irRC) SCLC cohort (n=43, 42, 45)	92.9 Percent of participants
Placebo + Paclitaxel/Carboplatin	Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC	DCR (mWHO criteria) NSCLC cohort (n=70, 68, 66)	72.7 Percent of participants
Placebo + Paclitaxel/Carboplatin	Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC	rDCR (irRC) SCLC cohort (n=43, 42, 45)	95.6 Percent of participants
Placebo + Paclitaxel/Carboplatin	Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC	DCR (mWHO criteria) SCLC cohort (n=43, 42, 45)	93.3 Percent of participants
Placebo + Paclitaxel/Carboplatin	Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC	irDCR (irRC) NSCLC cohort (n=70, 68, 66)	81.8 Percent of participants

Secondary

Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC

irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first. For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment. By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first. For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.

Time frame: Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)

Population: All participants who were randomized to a treatment group.

Arm	Measure	Group	Value (MEDIAN)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC	irDoR (irRC) SCLC cohort (n=43, 42, 45)	5.95 Months
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC	DoR (mWHO criteria) SCLC cohort (n=43, 42, 45)	7.62 Months
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC	irDoR (irRC) NSCLC cohort (n=70, 63, 62)	6.70 Months
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC	DoR (mWHO criteria) NSCLC cohort (n=70, 63, 62)	5.42 Months
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC	irDoR (irRC) SCLC cohort (n=43, 42, 45)	5.78 Months
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC	DoR (mWHO criteria) NSCLC cohort (n=70, 63, 62)	5.55 Months
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC	DoR (mWHO criteria) SCLC cohort (n=43, 42, 45)	5.78 Months
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC	irDoR (irRC) NSCLC cohort (n=70, 63, 62)	5.55 Months
Placebo + Paclitaxel/Carboplatin	Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC	DoR (mWHO criteria) SCLC cohort (n=43, 42, 45)	4.21 Months
Placebo + Paclitaxel/Carboplatin	Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC	irDoR (irRC) NSCLC cohort (n=70, 63, 62)	4.01 Months
Placebo + Paclitaxel/Carboplatin	Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC	DoR (mWHO criteria) NSCLC cohort (n=70, 63, 62)	4.01 Months
Placebo + Paclitaxel/Carboplatin	Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC	irDoR (irRC) SCLC cohort (n=43, 42, 45)	4.21 Months

Secondary

irPFS in Participants With SCLC Per irRC

IRC performed TA.

Time frame: Randomization date to date of irPD or death (maximum reached: 22 months)

Population: All participants with SCLC who were randomized to a treatment group.

Arm	Measure	Value (MEAN)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	irPFS in Participants With SCLC Per irRC	5.68 Months
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	irPFS in Participants With SCLC Per irRC	6.44 Months
Placebo + Paclitaxel/Carboplatin	irPFS in Participants With SCLC Per irRC	5.26 Months

p-value: 0.109895% CI: [0.475, 1.188]1-sided log rank

p-value: 0.028295% CI: [0.403, 1.1016]1-sided log rank

Secondary

Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings

Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.

Time frame: At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent

Population: All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	Vital sign measurements	0 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	Physical examination findings	0 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	Vital sign measurements	0 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	Physical examination findings	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	Vital sign measurements	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	Physical examination findings	0 Participants

Secondary

Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade

ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. CTC grade criteria: ALT Grade 1:\>ULN to 2.5\*ULN; Grade 2: \>2.5 to 5.0\*ULN; Grade 3: \>5.0 to 20.0\*ULN; Grade 4: \>20.0\*ULN. AST Grade 1: \>ULN to 2.5\*ULN; Grade 2: \>2.5 to 5.0\*ULN; Grade 3: \>5.0 to 20.0\*ULN; Grade 4: \>20.0\*ULN. Total bilirubin Grade 1: \>ULN to 1.5\*ULN; Grade 2: \>1.5 to 3.0\*ULN; Grade 3: \>3.0 to 10.0\*ULN; Grade 4: \>10.0\*ULN. ALK (U/L) G1:\>ULN to 2.5\*ULN, G2:\>2.5 to 5.0\*ULN, G3:\>5.0 to 20.0\*ULN, G4:\>20.0\*ULN.

Time frame: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent

Population: All participants with NSCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study liver function measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Alkaline phosphatase, Grade 2	1 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Total bilirubin, Grades 3 and 4	0 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Aspartate aminotransferase (AST), Grade 1	16 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Alkaline phosphatase, Grade 1	24 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Alanine aminotransferase (ALT), Grade 1	24 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	AST, Grade 2	0 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Total bilirubin, Grade 2	3 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Alkaline phosphatase, Grades 3 and 4	0 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	AST, Grades 3 and 4	1 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	ALT, Grade 2	2 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	ALT, Grades 3 and 4	1 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Total bilirubin, Grade 1	1 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	ALT, Grades 3 and 4	1 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Alkaline phosphatase, Grade 1	28 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Total bilirubin, Grades 3 and 4	0 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	ALT, Grade 2	4 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Alkaline phosphatase, Grade 2	2 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Alkaline phosphatase, Grades 3 and 4	1 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Total bilirubin, Grade 1	3 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Aspartate aminotransferase (AST), Grade 1	18 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	AST, Grade 2	2 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Alanine aminotransferase (ALT), Grade 1	15 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	AST, Grades 3 and 4	1 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Total bilirubin, Grade 2	2 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Alkaline phosphatase, Grades 3 and 4	1 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Total bilirubin, Grade 2	1 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Alanine aminotransferase (ALT), Grade 1	19 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	ALT, Grade 2	3 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	ALT, Grades 3 and 4	1 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Aspartate aminotransferase (AST), Grade 1	20 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	AST, Grade 2	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	AST, Grades 3 and 4	1 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Total bilirubin, Grades 3 and 4	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Alkaline phosphatase, Grade 1	24 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Alkaline phosphatase, Grade 2	3 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade	Total bilirubin, Grade 1	2 Participants

Secondary

Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

Time frame: Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)

Population: All participants with NSCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Grade 5	20 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Drug-related	20 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs, Grades 3 and 4	40 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to disc, Drug-related Grade 3	9 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to disc, Drug-related (all)	16 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Grade 3	17 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs (total)	71 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to discontinuation (disc) (total)	28 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Grade 4	10 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	Deaths (total)	52 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs, Drug-related Grade 5	2 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	Deaths within 30 days of last dose of study drug	11 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to disc, Drug-related Grade 5	1 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs, Drug-related Grades 3 and 4	29 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to disc, Drug-related Grade 4	1 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	Deaths within 70 days of last dose of study drug	21 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Drug-related Grade 5	2 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs, Drug-related Any Grade	56 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs (total)	49 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to disc, Drug-related Grade 5	0 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Grade 5	15 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Drug-related Grade 5	1 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	Deaths (total)	50 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	Deaths within 30 days of last dose of study drug	7 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	Deaths within 70 days of last dose of study drug	16 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs (total)	36 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Grade 4	4 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Grade 3	16 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Drug-related	13 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to discontinuation (disc) (total)	19 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to disc, Drug-related (all)	7 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to disc, Drug-related Grade 3	6 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to disc, Drug-related Grade 4	0 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs (total)	64 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs, Grades 3 and 4	36 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs, Drug-related Any Grade	56 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs, Drug-related Grades 3 and 4	26 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs, Drug-related Grade 5	1 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	Deaths within 30 days of last dose of study drug	8 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs, Drug-related Any Grade	54 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to disc, Drug-related Grade 4	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs, Drug-related Grade 5	2 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	Deaths (total)	51 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to disc, Drug-related Grade 5	1 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to discontinuation (disc) (total)	15 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Drug-related	11 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs (total)	64 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Drug-related Grade 5	2 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Grade 3	9 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Grade 5	18 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs (total)	33 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs, Grades 3 and 4	26 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to disc, Drug-related (all)	8 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	SAEs, Grade 4	5 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs, Drug-related Grades 3 and 4	24 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	AEs leading to disc, Drug-related Grade 3	4 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade	Deaths within 70 days of last dose of study drug	18 Participants

Secondary

Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline

An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.

Time frame: Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment

Population: Participants with at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.

Arm	Measure	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline	2 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline	1 Participants

Secondary

Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings

Time frame: Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment

Population: All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	Vital sign measurements	0 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	Physical examination findings	0 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	Vital sign measurements	0 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	Physical examination findings	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	Vital sign measurements	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings	Physical examination findings	0 Participants

Secondary

Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade

ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. ULN=Upper limit of normal among all laboratory ranges. CTC grade criteria: ALT Grade 1:\>ULN to 2.5\*ULN; Grade 2: \>2.5 to 5.0\*ULN; Grade 3: \>5.0 to 20.0\*ULN; Grade 4: \>20.0\*ULN. AST Grade 1: \>ULN to 2.5\*ULN; Grade 2: \>2.5 to 5.0\*ULN; Grade 3: \>5.0 to 20.0\*ULN; Grade 4: \>20.0\*ULN. Total bilirubin Grade 1: \>ULN to 1.5\*ULN; Grade 2: \>1.5 to 3.0\*ULN; Grade 3: \>3.0 to 10.0\*ULN; Grade 4: \>10.0\*ULN. ALK (U/L) G1:\>ULN to 2.5\*ULN, G2:\>2.5 to 5.0\*ULN, G3:\>5.0 to 20.0\*ULN, G4:\>20.0\*ULN.

Time frame: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment

Population: All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study liver function test result available.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	AST, Grade 2	4 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALT, Grades 3 & 4	7 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALK, Grade 2	1 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	AST, Grades 3 & 4	5 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALT, Grade 2	2 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALK, Grades 3 & 4	0 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	Total bilirubin, Grade 2	1 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALT, Grade 1	12 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALK, Grade 1	15 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	AST, Grade 1	11 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	Total bilirubin, Grades 3 & 4	1 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	Total bilirubin, Grade 1	4 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALK, Grades 3 & 4	0 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	AST, Grade 2	1 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	Total bilirubin, Grade 1	5 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	Total bilirubin, Grade 2	0 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	Total bilirubin, Grades 3 & 4	0 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALK, Grade 1	14 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALK, Grade 2	3 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	AST, Grade 1	13 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALT, Grade 1	12 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALT, Grade 2	3 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALT, Grades 3 & 4	2 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	AST, Grades 3 & 4	3 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	AST, Grades 3 & 4	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALT, Grade 2	1 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALK, Grade 1	16 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	Total bilirubin, Grades 3 & 4	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALT, Grades 3 & 4	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	Total bilirubin, Grade 2	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	AST, Grade 2	2 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	Total bilirubin, Grade 1	3 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALK, Grades 3 & 4	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	AST, Grade 1	12 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALT, Grade 1	8 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade	ALK, Grade 2	2 Participants

Secondary

Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade

CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:\<LLN to 3.0\*10\^9/L, Gr 2:\<3.0 to 2.0\*10\^9/L, Gr 3:\<2.0 to 1.0\*10\^9/L, Gr 4:\<1.0\*10\^9/L. ANC Gr 1:\<LLN to 1.5\*10\^9/L, Gr 2:\<1.5 to 1.0\*10\^9/L, Gr 3:\<1.0 to 0.5\*10\^9/L, Gr 4:\<0.5\*10\^9/L. Platelet count Gr 1:LLN to 75.0\*10\^9/L, Gr 2:\<75.0 to 50.0\*10\^9/L, Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Hemoglobin Gr 1:\<LLN to 10.0 g/dL, Gr 2:\<10.0 to 8.0 g/dL, Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL.

Time frame: At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment

Population: All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study hematology test result available.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cells, Grade 4 (n= 39, 42, 43)	0 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelet count, Grade 4 (n= 39, 42, 43)	0 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grade 1 (n= 39, 42, 43)	26 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cells, Grade 2 (n= 39, 42, 43)	10 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grade 2 (n= 39, 42, 43)	8 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Absolute neutrophil count, Grade 1 (n= 39, 42, 43)	8 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grade 3 (n= 39, 42, 43)	2 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grade 4 (n= 39, 42, 43)	0 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Absolute neutrophil count, Grade 2 (n= 39, 42, 43)	8 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Absolute neutrophil count, Grade 3 (n= 39, 42, 43)	2 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Absolute neutrophil count, Grade 4 (n= 39, 42, 43)	1 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cells, Grades 3 (n= 39, 42, 43)	0 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelet count, Grade 1 (n= 39, 42, 43)	15 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelet count, Grade 2 (n= 39, 42, 43)	2 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cells, Grade 1 (n=39, 42, 43)	7 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelet count, Grade 3 (n= 39, 42, 43)	1 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelet count, Grade 2 (n= 39, 42, 43)	3 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Absolute neutrophil count, Grade 2 (n= 39, 42, 43)	9 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelet count, Grade 4 (n= 39, 42, 43)	1 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cells, Grade 4 (n= 39, 42, 43)	0 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelet count, Grade 1 (n= 39, 42, 43)	18 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grade 1 (n= 39, 42, 43)	24 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Absolute neutrophil count, Grade 3 (n= 39, 42, 43)	2 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cells, Grade 1 (n=39, 42, 43)	11 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grade 2 (n= 39, 42, 43)	10 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cells, Grades 3 (n= 39, 42, 43)	2 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Absolute neutrophil count, Grade 4 (n= 39, 42, 43)	2 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grade 3 (n= 39, 42, 43)	2 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Absolute neutrophil count, Grade 1 (n= 39, 42, 43)	8 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelet count, Grade 3 (n= 39, 42, 43)	2 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grade 4 (n= 39, 42, 43)	2 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cells, Grade 2 (n= 39, 42, 43)	9 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grade 4 (n= 39, 42, 43)	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cells, Grade 1 (n=39, 42, 43)	13 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cells, Grade 2 (n= 39, 42, 43)	7 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cells, Grades 3 (n= 39, 42, 43)	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cells, Grade 4 (n= 39, 42, 43)	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Absolute neutrophil count, Grade 1 (n= 39, 42, 43)	8 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Absolute neutrophil count, Grade 3 (n= 39, 42, 43)	1 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Absolute neutrophil count, Grade 4 (n= 39, 42, 43)	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelet count, Grade 1 (n= 39, 42, 43)	23 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelet count, Grade 2 (n= 39, 42, 43)	3 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelet count, Grade 3 (n= 39, 42, 43)	1 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelet count, Grade 4 (n= 39, 42, 43)	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grade 1 (n= 39, 42, 43)	25 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grade 2 (n= 39, 42, 43)	11 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grade 3 (n= 39, 42, 43)	3 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Absolute neutrophil count, Grade 2 (n= 39, 42, 43)	91 Participants

Secondary

Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline

Time frame: Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment

Population: Participants with SCLC who had at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline	Positive at any timepoint (n=42, 42)	2 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline	Positive postbaseline (n=38, 41)	2 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline	Positive at any timepoint (n=42, 42)	3 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline	Positive postbaseline (n=38, 41)	0 Participants

Secondary

Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade

Time frame: Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)

Population: All participants with SCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Drug-related (all)	36 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to disc, Drug-related Grade 4	2 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Grade 5	12 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	Deaths within 30 days of last dose of study drug	6 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to disc, Drug-related Grade 3	3 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Drug-related	10 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Grades 3 and 4	19 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Drug-related Grade 5	1 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	Deaths within 70 days of last dose of study drug	13 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to disc, Drug-related (all)	9 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to discontinuation (disc) (total)	14 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Grade 5	12 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	Deaths (total)	37 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs (total)	25 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Drug-related, Grade 5	1 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs (total)	41 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Grade 3	7 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Drug-related,Grades 3 and 4	18 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to disc, Drug-related Grade 5	1 Participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Grade 4	3 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs (total)	40 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	Deaths (total)	31 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Grade 5	7 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	Deaths within 30 days of last dose of study drug	2 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	Deaths within 70 days of last dose of study drug	7 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs (total)	21 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Grade 3	6 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Grade 4	4 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Grade 5	7 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Drug-related	12 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Drug-related Grade 5	0 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to discontinuation (disc) (total)	13 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to disc, Drug-related (all)	7 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to disc, Drug-related Grade 3	3 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to disc, Drug-related Grade 4	2 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to disc, Drug-related Grade 5	0 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Grades 3 and 4	22 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Drug-related (all)	40 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Drug-related,Grades 3 and 4	21 Participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Drug-related, Grade 5	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to disc, Drug-related Grade 4	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Grade 3	4 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Grade 5	7 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to disc, Drug-related Grade 5	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs (total)	20 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	Deaths within 70 days of last dose of study drug	8 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs (total)	43 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	Deaths within 30 days of last dose of study drug	1 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Drug-related, Grade 5	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Grades 3 and 4	19 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Drug-related	6 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to disc, Drug-related (all)	7 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to discontinuation (disc) (total)	12 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Drug-related Grade 5	0 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Drug-related,Grades 3 and 4	13 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Grade 5	7 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	Deaths (total)	35 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs leading to disc, Drug-related Grade 3	4 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	SAEs, Grade 4	4 Participants
Placebo + Paclitaxel/Carboplatin	Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade	AEs, Drug-related (all)	40 Participants

Secondary

Overall Survival in Participants With NSCLC

Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.

Time frame: Randomization date to date of death (of censored, maximum reached: 26.5 months)

Population: All NSCLC participants who were randomized to a treatment group.

Arm	Measure	Value (MEDIAN)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Overall Survival in Participants With NSCLC	9.69 Months
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Overall Survival in Participants With NSCLC	12.22 Months
Placebo + Paclitaxel/Carboplatin	Overall Survival in Participants With NSCLC	8.28 Months

p-value: 0.475995% CI: [0.669, 1.46]1-sided log rank

p-value: 0.23495% CI: [0.587, 1.278]1-sided log rank

Secondary

Overall Survival in Participants With SCLC

Time frame: Randomization date to date of death (of censored, maximum reached: 22 months)

Population: All participants with SCLC who were randomized to a treatment group.

Arm	Measure	Value (MEDIAN)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Overall Survival in Participants With SCLC	3.89 Months
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Overall Survival in Participants With SCLC	5.22 Months
Placebo + Paclitaxel/Carboplatin	Overall Survival in Participants With SCLC	5.19 Months

p-value: 0.413295% CI: [0.585, 1.536]1-sided Log Rank

p-value: 0.128795% CI: [0.461, 1.232]1-sided Log Rank

Secondary

Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade

CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:\<LLN to 3.0\*10\^9/L, Gr 2:\<3.0 to 2.0\*10\^9/L, Gr 3:\<2.0 to 1.0\*10\^9/L, Gr 4:\<1.0\*10\^9/L. ANC Gr 1:\<LLN to 1.5\*10\^9/L, Gr 2:\<1.5 to 1.0\*10\^9/L, Gr 3:\<1.0 to 0.5\*10\^9/L, Gr 4:\<0.5\*10\^9/L. Platelet count Gr 1:LLN to 75.0\*10\^9/L, Gr 2:\<75.0 to 50.0\*10\^9/L, Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Hemoglobin Gr 1:\<LLN to 10.0 g/dL, Gr 2:\<10.0 to 8.0 g/dL, Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL.

Time frame: At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent

Population: All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study hematology test result available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	ANC, Grades 3 and 4	7.7 Percentage of participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grades 3 and 4	10.8 Percentage of participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cell count, Grades 3 and 4	7.7 Percentage of participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelets, Grades 3 and 4	1.5 Percentage of participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Any grade	90.8 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grades 3 and 4	6.2 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cell count, Grades 3 and 4	6.2 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Any grade	98.5 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	ANC, Grades 3 and 4	1.5 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelets, Grades 3 and 4	3.1 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Platelets, Grades 3 and 4	9.5 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	ANC, Grades 3 and 4	9.5 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	White blood cell count, Grades 3 and 4	3.2 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Grades 3 and 4	6.3 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade	Hemoglobin, Any grade	90.2 Percentage of participants

Secondary

Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade

ULN=upper limit of normal. Lipase (U/L) Gr 1: 1.1 to 1.39\*ULN; Gr 2: \>1.5 to 2.0\*ULN; Gr 3: 2.5 to 5; Gr 4: 5\*ULN. Amylase (U/L) Gr 1: \>ULN to 1.5\*ULN; Grade 2 \>1.5 to 2.0\*ULN, Grade 3 \>2.0 to 5.0\*ULN, Grade 4 \>5.0\*ULN. Creatine (mg/dL) Grade 1: \>ULN to 1.5\*ULN, Gr 2: 1.5 to 3.0\*ULN, Gr 3: \>3.0 to 6.0\*ULN, Gr 4: \>6.0\*ULN.

Time frame: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment

Population: All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study pancreatic enzyme laboratory test measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade	Lipase, Grades 3 and 4	7.7 Percentage of participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade	Amylase, Grades 3 and 4	1.5 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade	Lipase, Grades 3 and 4	6.2 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade	Amylase, Grades 3 and 4	4.6 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade	Lipase, Grades 3 and 4	3.2 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade	Amylase, Grades 3 and 4	1.6 Percentage of participants

Secondary

Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade

ULN=upper limit of normal. Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39\*ULN; Gr 2: \>1.5 to 2.0\*ULN; Gr 3: 2.5 to 5; Gr 4: 5\*ULN. Amylase (U/L) Gr 1: \>ULN to 1.5\*ULN; Gr 2 \>1.5 to 2.0\*ULN, Gr 3 \>2.0 to 5.0\*ULN, Gr 4 \>5.0\*ULN. Creatine (mg/dL) Gr 1: \>ULN to 1.5\*ULN, Gr 2: 1.5 to 3.0\*ULN, Gr 3: \>3.0 to 6.0\*ULN, Gr 4: \>6.0\*ULN.

Time frame: At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment

Population: All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study pancreatic enzyme or other laboratory test measurement available.

Arm	Measure	Group	Value (NUMBER)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade	Amylase, Grades 3 and 4	5.1 Percentage of participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade	Lipase, Grades 3 and 4	7.7 Percentage of participants
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade	Creatinine, Grades 3 and 4	0 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade	Amylase, Grades 3 and 4	4.8 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade	Lipase, Grades 3 and 4	16.7 Percentage of participants
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade	Creatinine, Grades 3 and 4	0 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade	Lipase, Grades 3 and 4	11.6 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade	Creatinine, Grades 3 and 4	0 Percentage of participants
Placebo + Paclitaxel/Carboplatin	Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade	Amylase, Grades 3 and 4	4.7 Percentage of participants

Secondary

Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria

By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.

Time frame: Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)

Population: All NSCLC participants who were randomized to a treatment group.

Arm	Measure	Value (MEAN)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria	4.11 Months
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria	5.13 Months
Placebo + Paclitaxel/Carboplatin	Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria	4.21 Months

p-value: 0.250295% CI: [0.612, 1.271]One-sided log rank

p-value: 0.02495% CI: [0.478, 0.999]One-sided log rank

Secondary

Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria

Time frame: Randomization date to date of progression or death (of censored, maximum reached: 22 months)

Population: All participants with SCLC who were randomized to a treatment group.

Arm	Measure	Value (MEAN)
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)	Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria	3.89 Months
Ipilimumab + Paclitaxel/Carboplatin (Sequential)	Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria	5.22 Months
Placebo + Paclitaxel/Carboplatin	Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria	5.19 Months

p-value: 0.384695% CI: [0.588, 1.481]1-sided Log Rank

p-value: 0.3795% CI: [0.591, 1.453]1-sided Log Rank

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026

Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)

Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC

Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)

Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC

Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC

irPFS in Participants With SCLC Per irRC

Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings

Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade

Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade

Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline

Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings

Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade

Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade

Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline

Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade

Overall Survival in Participants With NSCLC

Overall Survival in Participants With SCLC

Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade

Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade

Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade

Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria

Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria