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

NCT03088540Phase 3Completed

Lead sponsor
Regeneron Pharmaceuticals (Industry)
Enrollment
712 (actual)
Start date
29 May 2017
Primary completion
18 Apr 2025 (actual)
Study completion
18 Apr 2025
Last update posted
25 Jun 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover
Masking
None
Arms
2

Interventions

  • Pemetrexed Drug
  • Paclitaxel Drug
  • Gemcitabine Drug
  • Cisplatin Drug
  • Carboplatin Drug
  • cemiplimab Drug

Conditions and primary outcome

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

Primary outcome

Overall Survival (OS) (Up to 94 months); Progression-free Survival (PFS) Per Blinded IRC (Up to 94 months)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03088540 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Overall Survival (OS)

    Time frame
    Up to 94 months
    Measure
    Median
    Unit
    months

    • Cemiplimab vs ChemotherapySuperiority

      Estimate
      0.661Hazard Ratio (HR)
      95% CI, two-sided
      0.553 to 0.790
      p-value
      <0.0001
      Method
      Stratified log-rank

  2. Progression-free Survival (PFS) Per Blinded IRC

    Time frame
    Up to 94 months
    Measure
    Median
    Unit
    months

    • Cemiplimab vs ChemotherapySuperiority

      Estimate
      0.559Hazard Ratio (HR)
      95% CI, two-sided
      0.469 to 0.665
      p-value
      <0.0001
      Method
      Stratified log-rank

Serious adverse events

Time frame: From signing of first informed consent up to 94 months.

Participants with serious adverse events per group for NCT03088540, as posted
GroupAffectedAt risk
Cemiplimab131356
Extended Treatment: Cemiplimab + Chemotherapy2385
Chemotherapy103343
Crossover: Chemotherapy to Cemiplimab57191

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

6 on PubMed

  1. Review of patient-reported outcomes in EMPOWER-Lung 1 in patients with advanced non-small cell lung cancer treated with cemiplimab versus chemotherapy.

    Cancer · 2026 Mar 15

    PubMed 41808570 (opens in a new tab)DOI 10.1002/cncr.70339 (opens in a new tab)

  2. Clinical Interchangeability of PD-L1 Immunohistochemistry Assays in First-Line Non-Small Cell Lung Cancer Management With Cemiplimab.

    JCO precision oncology · 2025 Sep

    PubMed 40991883 (opens in a new tab)DOI 10.1200/PO-25-00177 (opens in a new tab)

  3. Cemiplimab Monotherapy for First-Line Treatment of Patients with Advanced NSCLC With PD-L1 Expression of 50% or Higher: Five-Year Outcomes of EMPOWER-Lung 1.

    Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2025 Jul

    PubMed 40118215 (opens in a new tab)DOI 10.1016/j.jtho.2025.03.033 (opens in a new tab)

  4. First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a mutlicentre, open-label, randomised, phase 3 trial.

    The Lancet. Oncology · 2023 Sep

    PubMed 37591293 (opens in a new tab)DOI 10.1016/S1470-2045(23)00329-7 (opens in a new tab)

  5. Patient-reported outcomes with cemiplimab monotherapy for first-line treatment of advanced non-small cell lung cancer with PD-L1 of ≥50%: The EMPOWER-Lung 1 study.

    Cancer · 2023 Jan 1

    PubMed 36308296 (opens in a new tab)DOI 10.1002/cncr.34477 (opens in a new tab)

  6. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial.

    Lancet (London, England) · 2021 Feb 13

    PubMed 33581821 (opens in a new tab)DOI 10.1016/S0140-6736(21)00228-2 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.