Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

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

Summary: To assess the safety and efficacy of REGN2810 as first-line treatment in patients with advanced or metastatic NSCLC whose tumors express PD-L1.

Detailed description: There is option to join genomics sub-study.

Eligibility: Inclusion Criteria:
  A patient must meet the following criteria to be eligible for inclusion in the study:
  1. Patients with histologically or cytologically documented squamous or non squamous NSCLC with stage IIIB or stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC
  2. Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
  3. Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory
  4. At least 1 radiographically measureable lesion per RECIST 1.1
  5. ECOG performance status of ≤1
  6. Anticipated life expectancy of at least 3 months
  7. Adequate organ and bone marrow function
  Exclusion Criteria:
  A patient who meets any of the following criteria will be excluded from the study:
  1. Patients that have never smoked, defined as smoking <100 cigarettes in a lifetime
  2. Active or untreated brain metastases or spinal cord compression
  3. Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations, or ROS1 fusions
  4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
  5. 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
  6. Patients with active, known, or suspected autoimmune disease that has required systemic therapy in the past 2 years
  7. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
  8. Another malignancy that is progressing or requires treatment
  9. Known active hepatitis B (positive result) or hepatitis C (known positive result) and known quantitative HCV RNA results greater than the lower limits of detection of the assay)
  10. Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome indicating uncontrolled active infection. Patients on highly active antiretroviral therapy with undetectable RNA levels and CD4 counts above 350 are permitted
  11. Active infection requiring systemic therapy within 14 days prior to randomization
  12. Prior therapy with anti-PD 1 or anti-PD L1
  13. Treatment-related immune-mediated AEs from immune-modulatory agents
  14. Receipt of an investigational drug or device within 30 days
  15. Receipt of a live vaccine within 30 days of planned start of study medication
  16. Major surgery or significant traumatic injury within 4 weeks prior to first dose
  17. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
  18. Known allergy to doxycycline or other tetracycline antibiotics
  19. Known psychiatric or substance abuse disorder that would interfere with participation with the requirements of the study, including current use of any illicit drugs
  20. Pregnant or breastfeeding women
  21. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose, during the study, and for at least 6 months after the last dose
  22. Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities will be excluded from this study

Relevance to patient case: not relevant