Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)-China Extension Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03850444
Recruitment Status : Active, not recruiting
First Posted : February 21, 2019
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Interventions Biological: pembrolizumab
Drug: carboplatin
Drug: paclitaxel
Drug: pemetrexed
Enrollment 262
Recruitment Details The China extension study enrolled 262 participants. Of the 262 total participants enrolled, 92 were also previously enrolled in the global study for MK-3475-042 (NCT02220894).
Pre-assignment Details These interim results are based on a database cutoff date of 04-September-2018, at which time 137 participants were ongoing in the study.
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Hide Arm/Group Description Participants received pembrolizumab 200 mg by IV infusion on Day 1 every 3 weeks (Q3W) for a maximum of 35 cycles (21-day cycles) Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
Period Title: Overall Study
Started 128 134
Completed 0 0
Not Completed 128 134
Reason Not Completed
Adverse Event             12             9
Death             38             64
Lost to Follow-up             0             1
Withdrawal by Subject             0             1
Ongoing in Study             78             59
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension Total
Hide Arm/Group Description Participants received pembrolizumab 200 mg by IV infusion on Day 1 every 3 weeks (Q3W) for a maximum of 35 cycles (21-day cycles) Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W Total of all reporting groups
Overall Number of Baseline Participants 128 134 262
Hide Baseline Analysis Population Description
The Baseline Analysis Population consisted of all randomized participants who were alive at the time of randomization and had a Tumor Proportion Score (TPS) ≥1%.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 134 participants 262 participants
60.9  (8.1) 61.5  (8.0) 61.2  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 134 participants 262 participants
Female
23
  18.0%
15
  11.2%
38
  14.5%
Male
105
  82.0%
119
  88.8%
224
  85.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 134 participants 262 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
128
 100.0%
134
 100.0%
262
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 134 participants 262 participants
ECOG PS=0
31
  24.2%
29
  21.6%
60
  22.9%
ECOG PS=1
97
  75.8%
105
  78.4%
202
  77.1%
[1]
Measure Description: Participants were assessed for ECOG PS: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature; Grade 2: Ambulatory & capable of all selfcare but unable to carry out any work activities, up & about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled, cannot carry on any selfcare, totally confined to bed or chair or Grade 5: Dead.
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 134 participants 262 participants
TPS=≥50%
72
  56.3%
74
  55.2%
146
  55.7%
TPS=20-49%
29
  22.7%
29
  21.6%
58
  22.1%
TPS=1-19%
27
  21.1%
31
  23.1%
58
  22.1%
TPS=<1%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Participants were assessed for their PD-L1 tumor expression status by immunohistochemistry assay using tumor tissue from an archival or newly obtained biopsy. Participants with a tumor proportion score (TPS) were classified as follows: ≥50% = PD-L1 strongly positive; 1-49% = PD-L1 weakly positive; and <1% = PD-L1 negative.
Tumor Histology   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 134 participants 262 participants
Squamous
71
  55.5%
76
  56.7%
147
  56.1%
Non-squamous
57
  44.5%
58
  43.3%
115
  43.9%
[1]
Measure Description: Participants were classified according to tumor histology: Squamous or Non-squamous. The tumor histology determined potential treatment regimen.
1.Primary Outcome
Title Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥50%
Hide Description OS was determined for participants with a TPS of ≥50% and was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The OS for participants with a TPS ≥50% is presented.
Time Frame Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥50%.
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
Overall Number of Participants Analyzed 72 74
Median (95% Confidence Interval)
Unit of Measure: Months
20.0 [1] 
(15.5 to NA)
14.0
(10.0 to 17.9)
[1]
NA=Upper Limit of Median OS not reached
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab-China Extension, Chemotherapy (SOC Treatment)-China Extension
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.38 to 1.00
Estimation Comments Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).
2.Primary Outcome
Title Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥20%
Hide Description OS was determined for participants with a TPS of ≥20% and was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The OS for participants with a TPS ≥20% is presented.
Time Frame Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥20%.
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
Overall Number of Participants Analyzed 101 103
Median (95% Confidence Interval)
Unit of Measure: Months
20.0 [1] 
(17.4 to NA)
13.7
(10.1 to 17.9)
[1]
NA=Upper Limit of Median OS not reached
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab-China Extension, Chemotherapy (SOC Treatment)-China Extension
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.41 to 0.95
Estimation Comments Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).
3.Primary Outcome
Title Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥1%
Hide Description OS was determined for participants with a TPS of ≥1% and was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The OS for participants with a TPS ≥1% is presented.
Time Frame Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥1%.
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
Overall Number of Participants Analyzed 128 134
Median (95% Confidence Interval)
Unit of Measure: Months
20.0 [1] 
(17.4 to NA)
13.7
(10.1 to 17.9)
[1]
NA=Upper Limit of Median OS not reached
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab-China Extension, Chemotherapy (SOC Treatment)-China Extension
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.45 to 0.94
Estimation Comments Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).
4.Secondary Outcome
Title Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥50%
Hide Description PFS was determined for participants with a TPS of ≥50% and was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions or progression in non-target lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants with a TPS ≥50% is presented.
Time Frame Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥50%.
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
Overall Number of Participants Analyzed 72 74
Median (95% Confidence Interval)
Unit of Measure: Months
8.3
(4.2 to 10.6)
6.5
(4.4 to 9.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab-China Extension, Chemotherapy (SOC Treatment)-China Extension
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.57 to 1.28
Estimation Comments Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).
5.Secondary Outcome
Title Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥20%
Hide Description PFS was determined for participants with a TPS of ≥20% and was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions or progression in non-target lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants with a TPS ≥20% is presented.
Time Frame Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥20%.
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
Overall Number of Participants Analyzed 101 103
Median (95% Confidence Interval)
Unit of Measure: Months
6.3
(4.2 to 8.4)
6.5
(5.9 to 8.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab-China Extension, Chemotherapy (SOC Treatment)-China Extension
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.70 to 1.39
Estimation Comments Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).
6.Secondary Outcome
Title Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥1%
Hide Description PFS was determined for participants with a TPS of ≥1% and was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions or progression in non-target lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants with a TPS ≥1% is presented.
Time Frame Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥1%.
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
Overall Number of Participants Analyzed 128 134
Median (95% Confidence Interval)
Unit of Measure: Months
6.3
(4.2 to 8.3)
6.4
(5.9 to 7.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab-China Extension, Chemotherapy (SOC Treatment)-China Extension
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.74 to 1.35
Estimation Comments Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).
7.Secondary Outcome
Title Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥50%
Hide Description ORR was determined for participants with a TPS of ≥50%. ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target and non-target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who had a TPS ≥50% and who experienced a CR or PR is presented.
Time Frame Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥50%.
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
Overall Number of Participants Analyzed 72 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
41.7
(30.2 to 53.9)
24.3
(15.1 to 35.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab-China Extension, Chemotherapy (SOC Treatment)-China Extension
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Stratified Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter r Difference in Percentage (DP)
Estimated Value 17.2
Confidence Interval (2-Sided) 95%
1.8 to 31.6
Estimation Comments DP for pembrolizumab vs. chemotherapy based on Miettinen & Nurminen method stratified by ECOG PS (0 vs. 1) and histology (squamous vs. non-squamous).
8.Secondary Outcome
Title Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥20%
Hide Description ORR was determined for participants with a TPS of ≥20%. ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target and non-target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who had a TPS ≥20% and who experienced a CR or PR is presented.
Time Frame Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥20%.
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
Overall Number of Participants Analyzed 101 103
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
35.6
(26.4 to 45.8)
24.3
(16.4 to 33.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab-China Extension, Chemotherapy (SOC Treatment)-China Extension
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage (DP)
Estimated Value 11.3
Confidence Interval (2-Sided) 95%
-1.4 to 23.7
Estimation Comments DP for pembrolizumab vs. chemotherapy based on Miettinen & Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).
9.Secondary Outcome
Title Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥1%
Hide Description ORR was determined for participants with a TPS of ≥1%. ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target and non-target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who had a TPS ≥1% and who experienced a CR or PR is presented.
Time Frame Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥1%.
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
Overall Number of Participants Analyzed 128 134
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
32.8
(24.8 to 41.7)
24.6
(17.6 to 32.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab-China Extension, Chemotherapy (SOC Treatment)-China Extension
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage (DP)
Estimated Value 8.0
Confidence Interval (2-Sided) 95%
-3.0 to 18.9
Estimation Comments DP for pembrolizumab vs. chemotherapy based on Miettinen & Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).
10.Secondary Outcome
Title Number of Participants Who Experienced At Least One Adverse Event (AE)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be 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 study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented. These safety results are based on a 04-September-2018 data cutoff date.
Time Frame Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received ≥1 dose of study treatment.
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
Overall Number of Participants Analyzed 128 125
Measure Type: Count of Participants
Unit of Measure: Participants
125
  97.7%
124
  99.2%
11.Secondary Outcome
Title Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be 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 study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. These safety results are based on a 04-September-2018 data cutoff date.
Time Frame Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received ≥1 dose of study treatment.
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
Overall Number of Participants Analyzed 128 125
Measure Type: Count of Participants
Unit of Measure: Participants
21
  16.4%
23
  18.4%
Time Frame Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)
Adverse Event Reporting Description Population: All participants receiving ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study drug are excluded as AEs.
 
Arm/Group Title Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Hide Arm/Group Description Participants received pembrolizumab 200 mg by IV infusion on Day 1 every 3 weeks (Q3W) for a maximum of 35 cycles (21-day cycles) Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
All-Cause Mortality
Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Affected / at Risk (%) Affected / at Risk (%)
Total   50/128 (39.06%)      71/125 (56.80%)    
Show Serious Adverse Events Hide Serious Adverse Events
Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/128 (29.69%)      40/125 (32.00%)    
Blood and lymphatic system disorders     
Agranulocytosis  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Anaemia  1  0/128 (0.00%)  0 5/125 (4.00%)  5
Coagulopathy  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Lymphadenopathy  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Neutropenia  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Thrombocytopenia  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Cardiac disorders     
Acute left ventricular failure  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Arteriosclerosis coronary artery  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Coronary artery disease  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Myocardial infarction  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Endocrine disorders     
Hyperthyroidism  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea  1  1/128 (0.78%)  1 1/125 (0.80%)  1
Lower gastrointestinal haemorrhage  1  1/128 (0.78%)  1 0/125 (0.00%)  0
General disorders     
Death  1  0/128 (0.00%)  0 2/125 (1.60%)  2
Fatigue  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Malaise  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Pyrexia  1  2/128 (1.56%)  2 1/125 (0.80%)  1
Hepatobiliary disorders     
Autoimmune hepatitis  1  2/128 (1.56%)  2 0/125 (0.00%)  0
Cholelithiasis  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Immune system disorders     
Anaphylactic reaction  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Infections and infestations     
Infection  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Lung abscess  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Lung infection  1  1/128 (0.78%)  1 1/125 (0.80%)  1
Pneumonia  1  8/128 (6.25%)  8 10/125 (8.00%)  12
Pulmonary tuberculosis  1  1/128 (0.78%)  1 1/125 (0.80%)  1
Septic shock  1  0/128 (0.00%)  0 2/125 (1.60%)  2
Upper respiratory tract infection  1  1/128 (0.78%)  1 1/125 (0.80%)  1
Injury, poisoning and procedural complications     
Craniocerebral injury  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Subdural haematoma  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Investigations     
Blood creatinine increased  1  1/128 (0.78%)  1 1/125 (0.80%)  1
Neutrophil count decreased  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Platelet count decreased  1  0/128 (0.00%)  0 3/125 (2.40%)  4
White blood cell count decreased  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  0/128 (0.00%)  0 2/125 (1.60%)  2
Diabetes mellitus  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Electrolyte imbalance  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Hyperuricaemia  1  2/128 (1.56%)  2 1/125 (0.80%)  2
Hypoalbuminaemia  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Ketoacidosis  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Musculoskeletal and connective tissue disorders     
Bone pain  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Joint range of motion decreased  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Neck pain  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to bone  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Oesophageal carcinoma  1  2/128 (1.56%)  2 0/125 (0.00%)  0
Nervous system disorders     
Cerebral infarction  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Dizziness  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Haemorrhage intracranial  1  1/128 (0.78%)  1 0/125 (0.00%)  0
VIth nerve disorder  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Renal and urinary disorders     
Haematuria  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Renal failure  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Cough  1  1/128 (0.78%)  1 1/125 (0.80%)  1
Haemoptysis  1  2/128 (1.56%)  2 0/125 (0.00%)  0
Interstitial lung disease  1  4/128 (3.13%)  5 0/125 (0.00%)  0
Pleural effusion  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Productive cough  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Pulmonary embolism  1  2/128 (1.56%)  2 3/125 (2.40%)  3
Respiratory failure  1  1/128 (0.78%)  1 1/125 (0.80%)  1
Skin and subcutaneous tissue disorders     
Drug eruption  1  0/128 (0.00%)  0 1/125 (0.80%)  2
Eczema  1  1/128 (0.78%)  1 0/125 (0.00%)  0
Urticaria  1  0/128 (0.00%)  0 1/125 (0.80%)  1
Vascular disorders     
Superior vena cava syndrome  1  0/128 (0.00%)  0 1/125 (0.80%)  1
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pembrolizumab-China Extension Chemotherapy (SOC Treatment)-China Extension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   116/128 (90.63%)      119/125 (95.20%)    
Blood and lymphatic system disorders     
Anaemia  1  36/128 (28.13%)  41 70/125 (56.00%)  110
Leukopenia  1  2/128 (1.56%)  2 16/125 (12.80%)  43
Neutropenia  1  0/128 (0.00%)  0 15/125 (12.00%)  25
Endocrine disorders     
Hyperthyroidism  1  7/128 (5.47%)  8 0/125 (0.00%)  0
Hypothyroidism  1  15/128 (11.72%)  18 0/125 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  5/128 (3.91%)  5 8/125 (6.40%)  9
Abdominal pain  1  2/128 (1.56%)  2 7/125 (5.60%)  7
Constipation  1  17/128 (13.28%)  19 30/125 (24.00%)  37
Diarrhoea  1  7/128 (5.47%)  12 13/125 (10.40%)  14
Nausea  1  10/128 (7.81%)  12 24/125 (19.20%)  36
Vomiting  1  9/128 (7.03%)  10 17/125 (13.60%)  22
General disorders     
Asthenia  1  5/128 (3.91%)  6 11/125 (8.80%)  12
Chest discomfort  1  7/128 (5.47%)  8 7/125 (5.60%)  8
Chest pain  1  6/128 (4.69%)  8 15/125 (12.00%)  16
Fatigue  1  10/128 (7.81%)  13 20/125 (16.00%)  37
Malaise  1  6/128 (4.69%)  6 16/125 (12.80%)  17
Pyrexia  1  28/128 (21.88%)  41 22/125 (17.60%)  23
Infections and infestations     
Nasopharyngitis  1  14/128 (10.94%)  16 4/125 (3.20%)  5
Upper respiratory tract infection  1  16/128 (12.50%)  21 9/125 (7.20%)  10
Investigations     
Alanine aminotransferase increased  1  27/128 (21.09%)  40 31/125 (24.80%)  55
Aspartate aminotransferase increased  1  27/128 (21.09%)  37 26/125 (20.80%)  44
Bilirubin conjugated increased  1  9/128 (7.03%)  12 3/125 (2.40%)  7
Blood albumin decreased  1  4/128 (3.13%)  5 8/125 (6.40%)  9
Blood bilirubin increased  1  12/128 (9.38%)  15 7/125 (5.60%)  9
Blood thyroid stimulating hormone increased  1  7/128 (5.47%)  8 4/125 (3.20%)  7
Blood uric acid increased  1  7/128 (5.47%)  8 0/125 (0.00%)  0
Gamma-glutamyltransferase increased  1  14/128 (10.94%)  18 11/125 (8.80%)  20
Neutrophil count decreased  1  3/128 (2.34%)  3 69/125 (55.20%)  227
Platelet count decreased  1  5/128 (3.91%)  6 29/125 (23.20%)  83
Weight decreased  1  17/128 (13.28%)  18 15/125 (12.00%)  19
White blood cell count decreased  1  5/128 (3.91%)  6 63/125 (50.40%)  240
Metabolism and nutrition disorders     
Decreased appetite  1  23/128 (17.97%)  24 38/125 (30.40%)  66
Hyperglycaemia  1  12/128 (9.38%)  12 7/125 (5.60%)  9
Hyperuricaemia  1  8/128 (6.25%)  14 5/125 (4.00%)  7
Hypoalbuminaemia  1  17/128 (13.28%)  21 18/125 (14.40%)  21
Hypocalcaemia  1  10/128 (7.81%)  10 1/125 (0.80%)  1
Hypokalaemia  1  17/128 (13.28%)  23 11/125 (8.80%)  17
Hyponatraemia  1  13/128 (10.16%)  21 12/125 (9.60%)  17
Hypoproteinaemia  1  12/128 (9.38%)  16 10/125 (8.00%)  14
Musculoskeletal and connective tissue disorders     
Arthralgia  1  12/128 (9.38%)  17 11/125 (8.80%)  20
Back pain  1  12/128 (9.38%)  22 9/125 (7.20%)  10
Musculoskeletal pain  1  11/128 (8.59%)  15 5/125 (4.00%)  5
Myalgia  1  4/128 (3.13%)  4 9/125 (7.20%)  13
Pain in extremity  1  7/128 (5.47%)  9 13/125 (10.40%)  16
Nervous system disorders     
Dizziness  1  8/128 (6.25%)  9 5/125 (4.00%)  5
Hypoaesthesia  1  3/128 (2.34%)  3 11/125 (8.80%)  13
Psychiatric disorders     
Insomnia  1  11/128 (8.59%)  15 12/125 (9.60%)  13
Respiratory, thoracic and mediastinal disorders     
Cough  1  25/128 (19.53%)  28 18/125 (14.40%)  18
Dyspnoea  1  15/128 (11.72%)  16 16/125 (12.80%)  16
Haemoptysis  1  21/128 (16.41%)  26 10/125 (8.00%)  11
Productive cough  1  7/128 (5.47%)  10 6/125 (4.80%)  6
Skin and subcutaneous tissue disorders     
Alopecia  1  1/128 (0.78%)  1 32/125 (25.60%)  33
Pruritus  1  17/128 (13.28%)  26 3/125 (2.40%)  3
Rash  1  22/128 (17.19%)  25 6/125 (4.80%)  6
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03850444     History of Changes
Other Study ID Numbers: 3475-042 China Extension
2014-001473-14 ( EudraCT Number )
152877 ( Other Identifier: JAPIC-CTI )
MK-3475-042 ( Other Identifier: Merck Protocol Number )
KEYNOTE-042 ( Other Identifier: Merck )
First Submitted: February 20, 2019
First Posted: February 21, 2019
Results First Submitted: August 5, 2019
Results First Posted: August 26, 2019
Last Update Posted: August 26, 2019