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CompletedLast updated: 9 January 2024

This phase III trial is trying to determine whether REGN2810 (a type of drug known as a monoclonal antibody) is better than standard chemotherapy as a first line treatment for people with advanced non-small cell lung cancer (PD L1+)A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer

Clinical summary

Summary

This study will be conducted across two arms; an experimental arm and a standard-of-care arm. In the experimental arm, participants will REGN2810 as a monotherapy. In the standard-of-care arm, participants will receive one of the following types of chemotherapy: Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance.

Conditions

This trial is treating patients with Non-Small Cell (NSC) Lung Cancer (PD-L1+ tumours).

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

More information

Trial Identifiers

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Trial sponsor

Regeneron Pharmaceuticals

Scientific Title

A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer

Eligibility

Inclusion

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 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
  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

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 randomization
  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 as long as pneumonitis resolved ≥6 months prior to randomization
  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. Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus (HIV) or diagnosis of immunodeficiency
  10. Active infection requiring systemic therapy within 14 days prior to randomization
  11. Prior therapy with anti-PD 1 or anti-PD L1
  12. Treatment-related immune-mediated AEs from immune-modulatory agents
  13. Receipt of an investigational drug or device within 30 days
  14. Receipt of a live vaccine within 30 days of planned start of study medication
  15. Major surgery or significant traumatic injury within 4 weeks prior to first dose
  16. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
  17. Known psychiatric or substance abuse disorder that would interfere with participation with the requirements of the study, including current use of any illicit drugs
  18. Pregnant or breastfeeding women
  19. 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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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