Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)

Conditions

Non Small Cell Lung Cancer (NSCLC)

Keywords

Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

Brief summary

This study compared two doses of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) who had experienced disease progression after platinum-containing systemic therapy. Participants were assigned randomly to receive either pembrolizumab 2 mg/kg once every three weeks (Q3W), pembrolizumab 10 mg/kg Q3W or docetaxel 75 mg/m\^2 Q3W. The total number of participants randomized depended upon demonstration of sufficient objective responses at an interim analysis. Eligible participants who were allocated to the first course of pembrolizumab (2 mg/kg Q3W or 10 mg/kg Q3W) and experienced disease progression, to be permitted to receive a second course of pembrolizumab as long as Inclusion/Exclusion criteria were met. Protocol Amendment 12 (effective date: 09 Dec 2015) enabled eligible participants who were allocated to docetaxel and experienced disease progression, to be permitted to switch over to receive pembrolizumab 2 mg/kg Q3W as long as Inclusion/Exclusion criteria were met. With Protocol Amendment 15 (effective date: 03 Jan 2018), all second course and switch over participants will receive pembrolizumab 200 mg Q3W. Response or progression during the second and switch over pembrolizumab courses will not count towards efficacy outcome measures, and adverse events during the second and switch over pembrolizumab courses will not count towards safety outcome measures. Also with Amendment 15, once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and enrolled in an extension study (Keynote 587; NCT03486873) to continue protocol-defined assessments and treatment. Switch over participants who have not transitioned to pembrolizumab will be considered for the extension study on a case-by-case basis. The primary study hypotheses are that pembolizumab prolongs Overall Survival (OS) and Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by independent radiologists' review in previously-treated participants with NSCLC in the strongly positive programmed cell death ligand 1 (PD-L1) stratum compared to docetaxel and in participants whose tumors express PD-L1 compared to docetaxel.

Park DJ, Thura M, Chiu VK, Vicuna B, Ang KH, Sanchez B, Chia PL, Kuan KY, Li J, Zhang K, Zheng WH, Hsien Ng MC, Zeng Q.

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Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial.

Herbst RS, Baas P, Kim DW, Felip E, Pérez-Gracia JL, Han JY, Molina J, Kim JH, Arvis CD, Ahn MJ, Majem M, Fidler MJ, de Castro G, Garrido M, Lubiniecki GM, Shentu Y, Im E, Dolled-Filhart M, Garon EB.

2015-12-194,947 citations

10.1016/s0140-6736(15)01281-7

A phase II/III randomized trial of two doses of MK-3475 versus docetaxel in previously treated subjects with non-small cell lung cancer.

Roy S. Herbst, Alfonso Gúrpide, Veerle Surmont, Dong‐Wan Kim, Saiama N. Waqar et al. (17 authors)

Journal of Clinical Oncology2014-05-205 citations

10.1200/jco.2014.32.15_suppl.tps8124

Interventions

BIOLOGICALPembrolizumab

IV infusion

DRUGDocetaxel

IV infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Life expectancy of at least 3 months * Histologically- or cytologically-confirmed diagnosis of NSCLC that is anti-programmed cell death ligand 1 (PD-L1) positive per central laboratory review * At least one bi-dimensional measurable lesion * Radiographic progression after treatment with at least 2 cycles of a platinum-containing doublet * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion criteria

* Prior therapy with docetaxel for NSCLC * Receiving systemic steroid therapy within 3 days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication * Currently participating or has participated in a study using an investigational antineoplastic agent or device within 30 days of first dose * Expected to require any other form of systemic or localized antineoplastic therapy while on trial * History of allogeneic tissue/solid organ transplant * Prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g., cetuximab), major surgery within 3 weeks of the first dose of study drug; received thoracic radiation therapy of \>30 Gy within 6 months of the first dose of study drug; received prior tyrosine kinase inhibitor therapy or completed palliative radiotherapy within 7 days of the first dose of study drug * Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways), or took part in another pembrolizumab trial * Known history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents * Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment * Known history or active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after last dose of pembrolizumab or 180 days after last dose of docetaxel

Design outcomes

Primary

Measure	Time frame	Description
Overall Survival (OS)	Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)	OS was defined as the time from randomization to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 September (Sep) 2015.
Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)	PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \>5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Percentage of Participants Experiencing Adverse Events (AEs)	Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)	An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Percentage of Participants Discontinuing Study Drug Due to AEs	Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)	An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.

Secondary

Measure	Time frame	Description
Overall Response Rate (ORR) by RECIST 1.1	Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)	ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) based on blinded independent central radiologists' review using RECIST 1.1. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Duration of Response (DOR) by RECIST 1.1	Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)	DOR is measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that death or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method and is reported in weeks. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.

Participant flow

Recruitment details

Participants who had non-small cell lung cancer (NSCLC) and whose tumors were assessed as being programmed cell death ligand 1 (PD-L1) positive were recruited for this study.

Pre-assignment details

Per protocol, response or progression during the second and switch over pembrolizumab courses was not counted towards efficacy outcome measures, and adverse events during the second and switch over pembrolizumab courses were not counted towards safety outcome measures. Final analyses for all primary and secondary outcome measures was done at the protocol-specified cutoff of 30-Sep-2015.

Participants by arm

Arm	Count
Pembrolizumab 2 mg/kg Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.	345
Pembrolizumab 10 mg/kg Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.	346
Docetaxel 75 mg/m^2 Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.	343
Total	1,034

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	23	17	18
Overall Study	Clinical Progression	103	78	59
Overall Study	Death	40	43	47
Overall Study	Excluded Medication	13	16	9
Overall Study	Lost to Follow-up	1	2	1
Overall Study	Physician Decision	5	8	12
Overall Study	Protocol Violation	2	1	1
Overall Study	Screen Failure	0	1	0
Overall Study	Sponsor Decision	1	0	0
Overall Study	Withdrawal by Subject	15	21	53

Baseline characteristics

Characteristic	Pembrolizumab 2 mg/kg	Pembrolizumab 10 mg/kg	Docetaxel 75 mg/m^2	Total
Age, Continuous	62.1 Years STANDARD_DEVIATION 9.6	62.3 Years STANDARD_DEVIATION 9.7	61.6 Years STANDARD_DEVIATION 9.8	62.0 Years STANDARD_DEVIATION 9.7
PD-L1 Tumor Expression Status Strongly PD-L1 Positive	139 Participants	151 Participants	152 Participants	442 Participants
PD-L1 Tumor Expression Status Weakly PD-L1 Positive	206 Participants	195 Participants	191 Participants	592 Participants
Sex: Female, Male Female	132 Participants	133 Participants	134 Participants	399 Participants
Sex: Female, Male Male	213 Participants	213 Participants	209 Participants	635 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	294 / 345	289 / 346	303 / 343	4 / 14	2 / 7	6 / 8
other Total, other adverse events	312 / 339	301 / 343	279 / 309	9 / 14	5 / 7	7 / 8
serious Total, serious adverse events	124 / 339	133 / 343	107 / 309	5 / 14	2 / 7	1 / 8

Outcome results

Primary

Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 September (Sep) 2015.

Time frame: Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)

Population: Per protocol, OS for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive OS data available and usable. Participants were included in the treatment group to which they were randomized.

Arm	Measure	Group	Value (MEDIAN)
Pembrolizumab 2 mg/kg	Overall Survival (OS)	Strongly PD-L1 Positive	14.9 Months
Pembrolizumab 2 mg/kg	Overall Survival (OS)	All PD-L1 Positive	10.4 Months
Pembrolizumab 10 mg/kg	Overall Survival (OS)	Strongly PD-L1 Positive	17.3 Months
Pembrolizumab 10 mg/kg	Overall Survival (OS)	All PD-L1 Positive	12.7 Months
Docetaxel 75 mg/m^2	Overall Survival (OS)	Strongly PD-L1 Positive	8.2 Months
Docetaxel 75 mg/m^2	Overall Survival (OS)	All PD-L1 Positive	8.5 Months

Comparison: In participants with strongly PD-L1 positive tumorsp-value: 0.0002495% CI: [0.38, 0.77]Log Rank

Comparison: In participants with strongly PD-L1 positive tumorsp-value: 0.0000295% CI: [0.36, 0.7]Log Rank

Comparison: In participants with PD-L1 positive tumorsp-value: 0.0007695% CI: [0.58, 0.88]Log Rank

Comparison: In participants with PD-L1 positive tumorsp-value: <0.0000195% CI: [0.49, 0.75]Log Rank

Primary

Percentage of Participants Discontinuing Study Drug Due to AEs

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.

Time frame: Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)

Population: Per protocol, participants discontinuing study treatment due to AEs, for the first pembrolizumab course and docetaxel treatment arms were analyzed in the APAT population. This consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.

Arm	Measure	Value (NUMBER)
Pembrolizumab 2 mg/kg	Percentage of Participants Discontinuing Study Drug Due to AEs	8.3 Percentage of Participants
Pembrolizumab 10 mg/kg	Percentage of Participants Discontinuing Study Drug Due to AEs	7.6 Percentage of Participants
Docetaxel 75 mg/m^2	Percentage of Participants Discontinuing Study Drug Due to AEs	13.6 Percentage of Participants

Primary

Percentage of Participants Experiencing Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.

Time frame: Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)

Population: Per protocol, participants experiencing AEs for the first pembrolizumab course and docetaxel treatment arms were analyzed in the All Participants As Treated (APAT) population. This consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.

Arm	Measure	Value (NUMBER)
Pembrolizumab 2 mg/kg	Percentage of Participants Experiencing Adverse Events (AEs)	97.6 Percentage of Participants
Pembrolizumab 10 mg/kg	Percentage of Participants Experiencing Adverse Events (AEs)	96.2 Percentage of Participants
Docetaxel 75 mg/m^2	Percentage of Participants Experiencing Adverse Events (AEs)	96.1 Percentage of Participants

Primary

Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \>5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.

Time frame: Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)

Population: Per protocol, PFS for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive PFS data available and usable. Participants were included in the treatment group to which they were randomized.

Arm	Measure	Group	Value (MEDIAN)
Pembrolizumab 2 mg/kg	Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	Strongly PD-L1 Positive	5.2 Months
Pembrolizumab 2 mg/kg	Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	All PD-L1 Positive	3.9 Months
Pembrolizumab 10 mg/kg	Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	Strongly PD-L1 Positive	5.2 Months
Pembrolizumab 10 mg/kg	Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	All PD-L1 Positive	4.0 Months
Docetaxel 75 mg/m^2	Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	Strongly PD-L1 Positive	4.1 Months
Docetaxel 75 mg/m^2	Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	All PD-L1 Positive	4.0 Months

Comparison: In participants with strongly PD-L1 positive tumorsp-value: 0.0000995% CI: [0.43, 0.77]Log Rank

Comparison: In participants with strongly PD-L1 positive tumorsp-value: 0.0000795% CI: [0.45, 0.78]Log Rank

Comparison: In participants with PD-L1 positive tumorsp-value: 0.0675895% CI: [0.73, 1.04]Log Rank

Comparison: In participants with PD-L1 positive tumorsp-value: 0.0046295% CI: [0.66, 0.94]Log Rank

Secondary

Duration of Response (DOR) by RECIST 1.1

DOR is measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that death or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method and is reported in weeks. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.

Time frame: Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)

Population: Per protocol, DOR for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who demonstrated a CR/PR and had strongly PD-L1 positive and all PD-L1 positive DOR data available and usable. Participants were included in the treatment group to which they were randomized.

Arm	Measure	Group	Value (MEDIAN)
Pembrolizumab 2 mg/kg	Duration of Response (DOR) by RECIST 1.1	Strongly PD-L1 Positive	NA Weeks
Pembrolizumab 2 mg/kg	Duration of Response (DOR) by RECIST 1.1	All PD-L1 Positive	NA Weeks
Pembrolizumab 10 mg/kg	Duration of Response (DOR) by RECIST 1.1	Strongly PD-L1 Positive	NA Weeks
Pembrolizumab 10 mg/kg	Duration of Response (DOR) by RECIST 1.1	All PD-L1 Positive	NA Weeks
Docetaxel 75 mg/m^2	Duration of Response (DOR) by RECIST 1.1	Strongly PD-L1 Positive	35 Weeks
Docetaxel 75 mg/m^2	Duration of Response (DOR) by RECIST 1.1	All PD-L1 Positive	27 Weeks

Secondary

Overall Response Rate (ORR) by RECIST 1.1

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) based on blinded independent central radiologists' review using RECIST 1.1. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.

Time frame: Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)

Population: Per protocol, ORR for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive ORR data available and usable. Participants were included in the treatment group to which they were randomized.

Arm	Measure	Group	Value (NUMBER)
Pembrolizumab 2 mg/kg	Overall Response Rate (ORR) by RECIST 1.1	Strongly PD-L1 Positive	30.2 Percentage of Participants
Pembrolizumab 2 mg/kg	Overall Response Rate (ORR) by RECIST 1.1	All PD-L1 Positive	18.0 Percentage of Participants
Pembrolizumab 10 mg/kg	Overall Response Rate (ORR) by RECIST 1.1	Strongly PD-L1 Positive	29.1 Percentage of Participants
Pembrolizumab 10 mg/kg	Overall Response Rate (ORR) by RECIST 1.1	All PD-L1 Positive	18.5 Percentage of Participants
Docetaxel 75 mg/m^2	Overall Response Rate (ORR) by RECIST 1.1	Strongly PD-L1 Positive	7.9 Percentage of Participants
Docetaxel 75 mg/m^2	Overall Response Rate (ORR) by RECIST 1.1	All PD-L1 Positive	9.3 Percentage of Participants

Comparison: In participants with strongly PD-L1 positive tumorsp-value: 0.6660895% CI: [-12.7, 8.2]Miettinen & Nurminen method

Comparison: In participants with strongly PD-L1 positive tumorsp-value: <0.0000195% CI: [14, 30.7]Miettinen & Nurminen method

Comparison: In participants with PD-L1 positive tumorsp-value: 0.0004595% CI: [3.6, 13.9]Miettinen & Nurminen method

Comparison: In participants with PD-L1 positive tumorsp-value: 0.0002495% CI: [4.1, 14.3]Miettinen & Nurminen method

Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Overall Survival (OS)

Percentage of Participants Discontinuing Study Drug Due to AEs

Percentage of Participants Experiencing Adverse Events (AEs)

Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Duration of Response (DOR) by RECIST 1.1

Overall Response Rate (ORR) by RECIST 1.1