Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

Korábbi kezelés

• Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
• History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to randomization
• Active infection requiring systemic therapy within 14 days prior to randomization
• Prior therapy with anti-PD 1 or anti-PD L1
• Receipt of an investigational drug or device within 30 days
• Receipt of a live vaccine within 30 days of planned start of study medication
• Major surgery or significant traumatic injury within 4 weeks prior to first dose
• Women of childbearing potential or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose
  • Note: Other protocol defined Inclusion/Exclusion criteria apply.

Más betegség

• Patients with active, known, or suspected autoimmune disease that has required systemic therapy in the past 2 years
• Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of randomization
• Another malignancy that is progressing or requires treatment
• Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus (HIV) or diagnosis of immunodeficiency
• Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
• Known psychiatric or substance abuse disorder that would interfere with participation with the requirements of the study, including current use of any illicit drugs

Laborértékek

• Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations, or ROS1 fusions

Egyéb

• A patient who meets any of the following criteria will be excluded from the study:
• Patients that have never smoked, defined as smoking \<100 cigarettes in a lifetime
• Active or untreated brain metastases or spinal cord compression
• Treatment-related immune-mediated AEs from immune-modulatory agents
• Pregnant or breastfeeding women

• A patient must meet the following criteria to be eligible for inclusion in the study:
• Patients with histologically or cytologically documented squamous or non squamous NSCLC with stage IIIB or stage IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC
• Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
• Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory
• At least 1 radiographically measureable lesion per RECIST 1.1
• ECOG performance status of ≤1
• Anticipated life expectancy of at least 3 months
• Adequate organ and bone marrow function