Non-Small Cell Lung Cancer
Conditions
Sponsors
Merck Biopharma Co., Ltd
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically confirmed diagnosis of advanced NSCLC -Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to Grade less than or equal to 1. For radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications. -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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy -Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee [Time Frame: Time from randomization to planned final assessment for unconfirmed BOR, expected at 26 months] -Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee [Time Frame: Time from randomization to planned final assessment, expected at 37 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics pharmacodynamics -Occurrences of Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 [Time Frame: Randomization up to the last safety follow-up visit, expected at approximately 47 months] -Overall Survival (OS) Time [Time Frame: Randomization up to 49 months] -Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Investigator [Time Frame: Time from randomization to planned final assessment for unconfirmed BOR, expected at 26 months] -Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Investigator [Time Frame: Time from randomization to planned final assessment, expected at 37 months] -Duration of Response Assessed from Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 Assessed by Independent Review Committee [Time Frame: Time from CR or PR to planned assessment, expected at 37 months] -Concentration of M7284 at the end of Infusion (Ceoi) [Time Frame: Pre-dose, 30 minutes post-dose at Week 1, 3, 5, 7 and 6 weekly during treatment up to safety follow-up visit (28 days after last dose, assessed up to 47 months)] -Concentration of M7284 at the end of the Dosing Interval (C trough) [Time Frame: Pre-dose, 30 minutes post-dose at Week 1, 3, 5, 7 and 6 weekly during treatment up to safety follow-up visit (28 days after last dose, assessed up to 47 months)] -Immunogenicity as measured by Anti-drug Antibodies Concentration [Time Frame: Randomization up to safety follow-up visit (28 days post last-dose of study drug administration, assessed up to 47 months)] | — |
Countries
Asia except Japan, Europe, Japan, North America, South America
Outcome results
None listed