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A phase 3, randomized, double-blind trial of pembrolizumab (MK 3475) with or without lenvatinib in participants with treatment-naïve, metastatic non-small cell lung cancer (NSCLC) who have a tumor proportion score (TPS) greater than or equal to 1%
Primary Objectives:
To compare PFS per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) based on blinded independent central review (BICR) of the combinations of pembrolizumab + lenvatinib versus pembrolizumab + matching placebo.
To compare OS of the combinations of pembrolizumab + lenvatinib versus pembrolizumab + matching placebo.
Secondary Objectives:
To compare objective response (OR) per RECIST 1.1 based on BICR of the combinations of pembrolizumab + lenvatinib versus pembrolizumab + matching placebo.
To evaluate the safety and tolerability of the combination of pembrolizumab + lenvatinib versus pembrolizumab + matching placebo.
To compare the mean change from baseline in the global health status/quality of life (QoL), cough, chest pain, dyspnea, and physical functioning between pembrolizumab + lenvatinib compared with pembrolizumab + matching placebo.
To compare the time to true deterioration (TTD) in global health status/QoL, cough, chest pain, dyspnea, and physical functioning between pembrolizumab + lenvatinib compared with pembrolizumab + matching placebo.
Primary Objectives:
To compare PFS per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) based on blinded independent central review (BICR) of the combinations of pembrolizumab + lenvatinib versus pembrolizumab + matching placebo.
To compare OS of the combinations of pembrolizumab + lenvatinib versus pembrolizumab + matching placebo.
Secondary Objectives:
To compare objective response (OR) per RECIST 1.1 based on BICR of the combinations of pembrolizumab + lenvatinib versus pembrolizumab + matching placebo.
To evaluate the safety and tolerability of the combination of pembrolizumab + lenvatinib versus pembrolizumab + matching placebo.
To compare the mean change from baseline in the global health status/quality of life (QoL), cough, chest pain, dyspnea, and physical functioning between pembrolizumab + lenvatinib compared with pembrolizumab + matching placebo.
To compare the time to true deterioration (TTD) in global health status/QoL, cough, chest pain, dyspnea, and physical functioning between pembrolizumab + lenvatinib compared with pembrolizumab + matching placebo.
Recruitment Status
Past Studies