Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
NCT03409614Phase 3Completed
- Lead sponsor
- Regeneron Pharmaceuticals (Industry)
- Enrollment
- 789 (actual)
- Start date
- 6 Mar 2018
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025
- Last update posted
- 18 May 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 5
Interventions
- REGN2810 Drug
- REGN2810/chemo/ipi Drug
- Chemotherapy Other
- Placebo Drug
Conditions and primary outcome
- Non-small Cell Lung Cancer
Primary outcome
Part 1: Overall Survival (OS) (Up to a maximum of 82.2 months); Part 2: OS (Up to a maximum of 68.4 months)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT03409614 (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
Part 1: Overall Survival (OS)
- Time frame
- Up to a maximum of 82.2 months
- Measure
- Median
- Unit
- months
Part 1: Cemiplimab + Chemotherapy vs Part 1: ChemotherapySuperiority
All analyses based on final database lock (DBL) were descriptive only with p-values reported as nominal.
- Estimate
- 0.813Hazard Ratio (HR)
- 95% CI, two-sided
- 0.601 to 1.100
- p-value
- 0.1782
- Method
- Stratified Log Rank
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab vs Part 1: ChemotherapySuperiority
All analyses based on final DBL were descriptive only.
- Estimate
- 0.642Hazard Ratio (HR)
- 95% CI, two-sided
- 0.472 to 0.874
- p-value
- Not given
- Method
- Not given
Part 2: OS
- Time frame
- Up to a maximum of 68.4 months
- Measure
- Median
- Unit
- months
Part 2: Cemiplimab + Chemotherapy vs Part 2: Placebo + ChemotherapySuperiority
All analyses based on final DBL were descriptive only with p-values reported as nominal.
- Estimate
- 0.662Hazard Ratio (HR)
- 95% CI, two-sided
- 0.531 to 0.825
- p-value
- 0.0002
- Method
- Stratified Log Rank
Serious adverse events
Time frame: From the time the informed consent was signed, up to approximately 83 months
| Group | Affected | At risk |
|---|---|---|
| Part 1: Cemiplimab + Chemotherapy | 38 | 108 |
| Part 1: Cemiplimab+AbbrevChemo+Ipilimumab | 39 | 109 |
| Part 1: Chemotherapy | 23 | 103 |
| Part 1: Chemotherapy to Cemiplimab | 7 | 31 |
| Part 2: Cemiplimab + Chemotherapy | 95 | 312 |
| Part 2: Placebo + Chemotherapy | 38 | 153 |
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
4 on PubMedCemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer with PD-L1 ≥ 1 %: A subgroup analysis from the EMPOWER-Lung 3 part 2 trial.
Lung cancer (Amsterdam, Netherlands) · 2024 Jul
PubMed 38820979 (opens in a new tab)DOI 10.1016/j.lungcan.2024.107821 (opens in a new tab)
Cemiplimab Plus Chemotherapy Could Be a First-Line Option for Advanced and Metastatic NSCLC: Results From the Phase 3 EMPOWER-Lung 3 Part 2 Trial.
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2023 Jul
PubMed 37348996 (opens in a new tab)DOI 10.1016/j.jtho.2023.04.001 (opens in a new tab)
Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial.
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2023 Jun
PubMed 37001859 (opens in a new tab)DOI 10.1016/j.jtho.2023.03.008 (opens in a new tab)
Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial.
Nature medicine · 2022 Nov
PubMed 36008722 (opens in a new tab)DOI 10.1038/s41591-022-01977-y (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.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT03409614 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
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.