The study will evaluate M7824 monotherapy versus pembrolizumab as 1L treatment for participants with advanced NSCLC with high PD-L1-tumor expression.
Name: M7824
Description: Participants will receive an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks starting from Day 1 up to disease progression.Type: DrugM7824
Name: Pembrolizumab
Description: Participants will receive an intravenous infusion of 200 mg Pembrolizumab once every 3 weeks starting from Day 1 up to disease progression.Type: DrugPembrolizumab
Allocation: Randomized
Parallel Assignment
There is one SNP
- Have measurable disease based on RECIST 1.1 - Have a life expectancy of at least 3 months - Availability of either tumor archival material (less than 6 months old) or fresh biopsies collected within 28 days (excluding bone biopsies) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment - PD-L1 high status as determined by central PD-L1 test or by prior testing using PD-L1 immunohistochemistry 22C3 pharmDx assay - Other protocol defined inclusion criteria could apply Exclusion Criteria: - The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation, if targeted therapy is locally approved - Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study - Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations - Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years - Other protocol defined exclusion criteria could apply Inclusion Criteria: - Histologically confirmed diagnosis of advanced NSCLC - Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. --- V600E ---
- Have measurable disease based on RECIST 1.1 - Have a life expectancy of at least 3 months - Availability of either tumor archival material (less than 6 months old) or fresh biopsies collected within 28 days (excluding bone biopsies) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment - PD-L1 high status as determined by central PD-L1 test or by prior testing using PD-L1 immunohistochemistry 22C3 pharmDx assay - Other protocol defined inclusion criteria could apply Exclusion Criteria: - The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation, if targeted therapy is locally approved - Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study - Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations - Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years - Other protocol defined exclusion criteria could apply Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- V600E ---