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)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: M7824; Pembrolizumab
Intervention description: Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.; Pembrolizumab: Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
Intervention MeSH terms: Pembrolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: M7824; Pembrolizumab; PD-L1-tumor Expression; INTR@PID Lung 037; Bintrafusp alfa

Summary:

      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.
    

Eligibility 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 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