Stage IV Small Cell Lung Cancer
Conditions
Keywords
Newly diagnosed Stage IV Small Cell Lung Cancer
Brief summary
The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 (tarextumab) in combination with etoposide (EP) for 6 cycles followed a Phase 2, multi center, randomized, placebo-controlled portion comparing the efficacy and safety of OMP-59R5 in combination with EP for 6 cycles followed by single agent OMP-59R5 relative to EP alone for 6 cycles in subjects receiving first-line therapy for extensive stage small cell lung cancer.
Detailed description
The Phase 1b lead-in portion of the study was conducted to determine the MTD of OMP-59R5 administered along with EP. The Phase 2 portion of the study was multi-center, randomized, and placebo-controlled. Subjects who qualified for enrollment into the Phase 2 portion of the study were randomized in a 1:1 ratio to receive study treatment of tarextumab along with EP (Arm A) or placebo along with EP (Arm B).
Interventions
DRUGOMP-59R5
OMP-59R5 administered intravenously
DRUGEtoposide
administered intravenously
DRUGPlacebo
administered IV
administered intravenously
Sponsors
OncoMed Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following criteria to be eligible for the study: 1. Histologically or cytologically documented extensive stage small cell lung cancer. 2. Adults of 18 years of age or older. 3. Performance Status (ECOG) of 0 or 1. 4. Formalin Fixed Paraffin Embedded (FFPE) tumor tissue. 5. Adequate organ function: 1. Adequate hematologic function (absolute neutrophil count \[ANC\] ≥ 1,500 cells/μL; hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL). 2. Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min using Cockcroft-Gault formula). 3. Adequate hepatic function (alanine aminotransferase \[ALT\] ≤ 3 x upper limit of normal \[ULN\], ALT may be ≤ 5 x ULN if due to liver metastases but cannot be associated with concurrent elevated bilirubin \>1.5 times the upper limit of normal (ULN) unless it is approved by the Sponsor's Medical Monitor). 4. Prothrombin Time (PT)/International Normalized Ration (INR) ≤1.5 × ULN, activated partial thromboplastin time (aPTT) ≤1.5 × ULN. 6. Written consent on an Institutional Review Board (IRB)/IndependentEthics Committee (IEC)-approved Informed Consent Form prior to any study-specific evaluation. 7. For women of child-bearing potential, negative serum pregnancy test at screening and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration or the last EP in the study, whichever is discontinued last. 8. Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration or the last EP in the study, whichever is discontinued last.
Exclusion criteria
Subjects who meet any of the following criteria will not be eligible for participation in the study: 1. Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation. 2. Prior therapy including radiation, chemotherapy or surgery for newly diagnosed extensive stage small cell lung cancer. 3. Presence of any serious or uncontrolled illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure unstable angina pectoris, uncontrolled cardiac arrhythmia, uncontrolled arterial thrombosis, symptomatic pulmonary embolism, and psychiatric illness that would limit compliance with study requirement. 4. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within 6 months prior to the first administration of study drug. 5. A history of malignancy with the exception of: 1. Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer 2. Adequately treated stage I cancer from which the subject is currently in remission, or 3. Any other cancer from which the subject has been disease-free for ≥ 3 years 6. Known human immunodeficiency virus (HIV) infection. 7. Females who are pregnant or breastfeeding. 8. Concurrent use of therapeutic warfarin (prophylactic low dose of warfarin, i.e., 1 mg daily for port catheter is allowed)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs) | Up to 1 year in absence of unacceptable toxicity or disease progression. | To determine the MTD of tarextumab when administered on Day 1 of each 21 day cycle along with etoposide 100 mg/m2 on Days 1, 2 and 3, and cisplatin 80 mg/m2 or carboplatin area under the curve (AUC) of 5 mg/mL•min on Day 1 in subjects with untreated extensive stage small cell lung cancer. DLT evaluable population includes all subjects who received at least 1 partial dose of OMP-59R5 during the Phase 1b dose escalation portion of the study including the carboplatin cohort and who had completed Day 21 cycle of 1 OMP-59R5 administration or had discontinued due to drug-related toxicity. |
| Phase 1b: Overall Response (Response Evaluable Population) | Up to 1 year in absence of unacceptable toxicity or disease progression. | The best overall response is defined as the best Investigator-assessed response recorded from the start of the treatment until disease progression in the following order of importance: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Evaluable (NE). Response evaluable population includes subjects who received 1 partial dose of OMP-59R5 and at at least 1 post tumor assessment. |
| Phase 2: Progression Free Survival (ITT Population) | Up to 1 year until disease progression or death. | To determine the improvement in Progression Free Survival (PFS) resulting from the addition of tarextumab to etoposide and platinum therapy (EP) in subjects receiving first-line therapy for extensive stage small cell lung cancer. PFS is based on the Investigator-assessments of tumor response which is defined as the number of days from randomization until death or disease progression as defined by RECIST criteria for the ITT Population. |
| Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) | Up to 1 year in absence of unacceptable toxicity or disease progression | The response rate is the number of subjects per treatment arm who have either a complete response (CR) or partial response (PR) for best overall response (according to RECIST criteria) divided by the number of subjects randomized to the respective arms. |
Countries
United States
Participant flow
Pre-assignment details
Phase 1b: Approximately 30 subjects were planned. A total of 27 subjects were enrolled. Phase 2: Approximately 135 subjects were planned to be randomized. A total of 145 subjects were enrolled/randomized. Total: 172 subjects were enrolled/randomized (Phase 1b and Phase 2)
Participants by arm
| Arm | Count |
|---|---|
| P1B: OMP-59R5 5mg/kg + ETO + CIS Cohort 1: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1). | 3 |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS Cohort 2: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1). | 3 |
| P1B: OMP-59R5 10 mg/kg + ETO + CIS Cohort 3: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3 and cisplatin 80 mg/m2 on Day 1). | 6 |
| P1B: OMP-59R5 12.5 mg/kg + ETO + CIS Cohort 4: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1). | 3 |
| P1B: OMP-59R5 15 mg/kg + ETO + CIS Cohort 5: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1). | 6 |
| P1B: OMP-59R5 15mg/kg + ETO + CARB Cohort 6: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and carboplatin AUC of 5 mg/mL•min (Day 1). | 6 |
| P2: OMP-59R5 15 mg/kg + ETO and CIS or CARB Active Arm: Subjects receive OMP-59R5 15 mg/kg and etoposide 100 mg/m2 and cisplatin 75 mg/m2 or carboplatin AUC 5 mg/kg \*min | 73 |
| P2: Placebo + CIS or CARB Placebo Arm: Active Arm: Subjects receive placebo and etoposide 100 mg/m2 and cisplatin 75 mg/m2 or carboplatin AUC 5 mg/kg \*min | 72 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 3 | 2 | 4 | 3 | 5 | 4 | 51 | 51 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 4 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Study Terminated by Sponsor | 0 | 0 | 0 | 0 | 1 | 0 | 16 | 14 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 | 0 | 0 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | P1B: OMP-59R5 5mg/kg + ETO + CIS | Total | P2: Placebo + CIS or CARB | P2: OMP-59R5 15 mg/kg + ETO and CIS or CARB | P1B: OMP-59R5 15mg/kg + ETO + CARB | P1B: OMP-59R5 15 mg/kg + ETO + CIS | P1B: OMP-59R5 12.5 mg/kg + ETO + CIS | P1B: OMP-59R5 10 mg/kg + ETO + CIS | P1B: OMP-59R5 7.5 mg/kg + ETO + CIS |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized Age | 68.3 years | 58.5 years | 65.4 years | 65.3 years | 57.2 years | 61.0 years | 64.3 years | 67.7 years | 72.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 13 Participants | 6 Participants | 6 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 155 Participants | 64 Participants | 66 Participants | 4 Participants | 6 Participants | 3 Participants | 6 Participants | 3 Participants |
| Region of Enrollment United States | 3 participants | 172 participants | 72 participants | 73 participants | 6 participants | 6 participants | 3 participants | 6 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 77 Participants | 37 Participants | 30 Participants | 3 Participants | 3 Participants | 0 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 95 Participants | 35 Participants | 43 Participants | 3 Participants | 3 Participants | 3 Participants | 4 Participants | 2 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 | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 3 | 2 / 3 | 4 / 6 | 3 / 3 | 5 / 6 | 4 / 6 | 51 / 72 | 51 / 73 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 6 / 6 | 3 / 3 | 6 / 6 | 6 / 6 | 68 / 68 | 69 / 69 |
| serious Total, serious adverse events | 1 / 3 | 2 / 3 | 6 / 6 | 1 / 3 | 0 / 6 | 3 / 6 | 29 / 68 | 37 / 69 |
Outcome results
Primary
Phase 1b: Overall Response (Response Evaluable Population)
The best overall response is defined as the best Investigator-assessed response recorded from the start of the treatment until disease progression in the following order of importance: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Evaluable (NE). Response evaluable population includes subjects who received 1 partial dose of OMP-59R5 and at at least 1 post tumor assessment.
Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Complete Response | 0 Participants |
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Partial Response | 3 Participants |
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Stable Disease | 0 Participants |
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Progressive Disease | 0 Participants |
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Not Evaluated | 0 Participants |
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Missing | 0 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Partial Response | 2 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Progressive Disease | 0 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Missing | 0 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Complete Response | 0 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Stable Disease | 1 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Not Evaluated | 0 Participants |
| P1B: OMP-59R5 10 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Missing | 0 Participants |
| P1B: OMP-59R5 10 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Not Evaluated | 0 Participants |
| P1B: OMP-59R5 10 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Progressive Disease | 0 Participants |
| P1B: OMP-59R5 10 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Stable Disease | 1 Participants |
| P1B: OMP-59R5 10 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Complete Response | 0 Participants |
| P1B: OMP-59R5 10 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Partial Response | 4 Participants |
| P1B: OMP-59R5 12.5 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Progressive Disease | 0 Participants |
| P1B: OMP-59R5 12.5 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Partial Response | 2 Participants |
| P1B: OMP-59R5 12.5 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Stable Disease | 1 Participants |
| P1B: OMP-59R5 12.5 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Missing | 0 Participants |
| P1B: OMP-59R5 12.5 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Not Evaluated | 0 Participants |
| P1B: OMP-59R5 12.5 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Complete Response | 0 Participants |
| P1B: OMP-59R5 15 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Complete Response | 0 Participants |
| P1B: OMP-59R5 15 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Not Evaluated | 0 Participants |
| P1B: OMP-59R5 15 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Partial Response | 5 Participants |
| P1B: OMP-59R5 15 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Stable Disease | 0 Participants |
| P1B: OMP-59R5 15 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Progressive Disease | 1 Participants |
| P1B: OMP-59R5 15 mg/kg + ETO + CIS | Phase 1b: Overall Response (Response Evaluable Population) | Missing | 0 Participants |
| P1B: OMP-59R5 15mg/kg + ETO + CARB | Phase 1b: Overall Response (Response Evaluable Population) | Progressive Disease | 1 Participants |
| P1B: OMP-59R5 15mg/kg + ETO + CARB | Phase 1b: Overall Response (Response Evaluable Population) | Stable Disease | 1 Participants |
| P1B: OMP-59R5 15mg/kg + ETO + CARB | Phase 1b: Overall Response (Response Evaluable Population) | Not Evaluated | 0 Participants |
| P1B: OMP-59R5 15mg/kg + ETO + CARB | Phase 1b: Overall Response (Response Evaluable Population) | Missing | 0 Participants |
| P1B: OMP-59R5 15mg/kg + ETO + CARB | Phase 1b: Overall Response (Response Evaluable Population) | Partial Response | 4 Participants |
| P1B: OMP-59R5 15mg/kg + ETO + CARB | Phase 1b: Overall Response (Response Evaluable Population) | Complete Response | 0 Participants |
Primary
Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs)
To determine the MTD of tarextumab when administered on Day 1 of each 21 day cycle along with etoposide 100 mg/m2 on Days 1, 2 and 3, and cisplatin 80 mg/m2 or carboplatin area under the curve (AUC) of 5 mg/mL•min on Day 1 in subjects with untreated extensive stage small cell lung cancer. DLT evaluable population includes all subjects who received at least 1 partial dose of OMP-59R5 during the Phase 1b dose escalation portion of the study including the carboplatin cohort and who had completed Day 21 cycle of 1 OMP-59R5 administration or had discontinued due to drug-related toxicity.
Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.
Population: The MTD of OMP-59R5 in combination with etoposide and cisplatin or carboplatin was not reached and the recommended phase 2 dose was determined to be 15 mg/kg every 21-day cycle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs) | 0 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs) | 0 Participants |
| P1B: OMP-59R5 10 mg/kg + ETO + CIS | Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs) | 1 Participants |
| P1B: OMP-59R5 12.5 mg/kg + ETO + CIS | Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs) | 0 Participants |
| P1B: OMP-59R5 15 mg/kg + ETO + CIS | Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs) | 0 Participants |
| P1B: OMP-59R5 15mg/kg + ETO + CARB | Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs) | 0 Participants |
Primary
Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population)
The response rate is the number of subjects per treatment arm who have either a complete response (CR) or partial response (PR) for best overall response (according to RECIST criteria) divided by the number of subjects randomized to the respective arms.
Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) | Complete Response | 2 Participants |
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) | Partial Response | 49 Participants |
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) | Stable Disease | 10 Participants |
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) | Progressive Disease | 4 Participants |
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) | Not Evaluable | 1 Participants |
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) | No Post-Baseline Tumor Assessment Collected | 6 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) | Not Evaluable | 1 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) | Complete Response | 1 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) | Progressive Disease | 2 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) | Partial Response | 49 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) | No Post-Baseline Tumor Assessment Collected | 11 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) | Stable Disease | 9 Participants |
Primary
Phase 2: Progression Free Survival (ITT Population)
To determine the improvement in Progression Free Survival (PFS) resulting from the addition of tarextumab to etoposide and platinum therapy (EP) in subjects receiving first-line therapy for extensive stage small cell lung cancer. PFS is based on the Investigator-assessments of tumor response which is defined as the number of days from randomization until death or disease progression as defined by RECIST criteria for the ITT Population.
Time frame: Up to 1 year until disease progression or death.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 2: Progression Free Survival (ITT Population) | Disease Progression or Death | 56 Participants |
| P1B: OMP-59R5 5mg/kg + ETO + CIS | Phase 2: Progression Free Survival (ITT Population) | Did not Progress or Die | 16 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 2: Progression Free Survival (ITT Population) | Disease Progression or Death | 51 Participants |
| P1B: OMP-59R5 7.5 mg/kg + ETO + CIS | Phase 2: Progression Free Survival (ITT Population) | Did not Progress or Die | 22 Participants |