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

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03088540
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma，Non-Small-Cell Lung
  • Lung Carcinomas, Non-Small-Cell
  • Non-small-cell Lung Carcinoma
  • Nonsmall Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
May 29, 2017
Status verified
Feb 2026
Primary completion
Apr 18, 2025
Completion
Apr 18, 2025

Study Design

Enrollment
712 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From date of randomization until the date of death, assessed up to 68 months ]

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