{"analyses":[{"ciLowerLimit":"-0.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"14.6","estimateComment":"DP for pembrolizumab vs. chemotherapy based on Miettinen \\& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0353","pValueComment":"One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \\>0","paramType":"Difference in Percentage (DP)","paramValue":"7.0","statisticalMethod":"Stratified Miettinen and Nurminen"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"33.6","upperLimit":"44.9","value":"39.1"},{"groupId":"OG001","lowerLimit":"26.8","upperLimit":"37.6","value":"32.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"299"},{"groupId":"OG001","value":"300"}],"units":"Participants"}],"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 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 efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was ORR in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The percentage of participants who had a TPS ≥50% and who experienced a CR or PR is presented.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)","id":"OG000","title":"Pembrolizumab"},{"description":"Participants received carboplatin at target dose 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","id":"OG001","title":"Chemotherapy (SOC Treatment)"}],"paramType":"NUMBER","populationDescription":"The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥50%.","reportingStatus":"POSTED","timeFrame":"Up to approximately 44 months","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%","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}