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

Overview

The primary objectives of the study are: – To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in ≥50% of tumor cells – To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in ≥50% of tumor cells The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2024

Detailed Description

There is option to join genomics sub-study.

Interventions

  • Drug: Pemetrexed
    • Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin
  • Drug: Paclitaxel
    • Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin
  • Drug: Gemcitabine
    • Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin
  • Drug: Cisplatin
    • Administered with either Pemetrexed, Paclitaxel or gemcitabine.
  • Drug: Carboplatin
    • Administered with either Pemetrexed, Paclitaxel or gemcitabine.
  • Drug: cemiplimab
    • Patients will be administered cemiplimab as per protocol.

Arms, Groups and Cohorts

  • Active Comparator: Standard-of-care chemotherapy
    • Standard-of-care chemotherapy will administered from these options: 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
  • Experimental: cemiplimab
    • cemiplimab regimen as monotherapy as per study protocol

Clinical Trial Outcome Measures

Primary Measures

  • Overall survival (OS)
    • Time Frame: From date of randomization until the date of death, assessed up to 68 months
  • Progression-free survival (PFS) as assessed by a blinded Independent review committee (IRC) using RECIST 1.1
    • Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months
    • PFS as assessed by a blinded IRC using RECIST 1.1.

Secondary Measures

  • Objective response rates (ORR)
    • Time Frame: From date of randomization to the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first, up to 68 months
    • The number of patients with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of patients in the efficacy analysis set
  • Best overall response (BOR)
    • Time Frame: From date of randomization until the date of first documented progression or the date of subsequent anti-cancer therapy, whichever came first, assessed up to 68 months
    • The BOR, as determined by the IRC per RECIST 1.1
  • Compare the duration of response (DOR) of cemiplimab versus platinum based chemotherapies
    • Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months
    • Duration of response will be defined as the time between the date of first response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy or death due to any cause, whichever comes first
  • Change from baseline in quality of life (QoL) scores as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
    • Time Frame: Baseline up to 26 months after treatment
  • Change from baseline in in lung cancer symptom scores as measured by the EORTC Lung Cancer 13 (EORTC QLQ-LC13)
    • Time Frame: Baseline up to 26 months after treatment
  • Incidence of Adverse Events (AEs)
    • Time Frame: Baseline up to 68 months after treatment
  • Incidence of serious adverse events (SAEs)
    • Time Frame: Baseline up to 68 months after treatment
  • Incidence of deaths
    • Time Frame: Baseline up to 68 months after treatment
  • Incidence of laboratory abnormalities
    • Time Frame: Baseline up to 68 months after treatment
    • Number of patients with laboratory abnormalities
  • Measure concentrations of cemiplimab in serum
    • Time Frame: Baseline up to 68 months after treatment
    • Maximum Plasma Concentration [Cmax]
  • Characterize the pharmacokinetics (PK) of cemiplimab
    • Time Frame: Baseline up to 68 months after treatment
    • Area Under the Curve [AUC]

Participating in This Clinical Trial

Key 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 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 Key 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 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Regeneron Pharmaceuticals
  • Collaborator
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trial Management, Study Director, Regeneron Pharmaceuticals

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