M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

Merck KGaA (EMD Serono)

Status and phase

Active, not recruiting

Phase 3

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Pembrolizumab

Drug: M7824

Study type

Interventional

Funder types

Industry

Identifiers

NCT03631706

MS200647_0037

2018-001517-32 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.

Enrollment

304 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 tumor tissue (less than 6 months old) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
PD-L1 high status as determined by central testing
Other protocol defined inclusion criteria could apply

Exclusion criteria

Participants with nonsquamous NSCLC histologies whose tumor harbors any of the following molecular alterations and targeted therapy is locally approved: epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation
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