A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer

NCT05800015Phase 2/3Active, not recruiting

Lead sponsor
Regeneron Pharmaceuticals (Industry)
Enrollment
160 (actual)
Start date
8 Aug 2023
Primary completion
16 Jan 2030 (estimated)
Study completion
23 Dec 2031
Last update posted
15 Jul 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
5

Interventions

  • fianlimab Drug
  • cemiplimab Drug
  • Pemetrexed Drug
  • Paclitaxel Drug
  • Carboplatin Drug
  • Cisplatin Drug
  • Placebo Drug

Conditions and primary outcome

  • Non-small Cell Lung Cancer

Primary outcome

Objective response rate (ORR) as assessed by blinded independent review committee (BICR) using RECIST 1.1 (Up to 136 Weeks); Overall Survival (OS) (Up to 5 years)

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

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

Publications

No PubMed citation lists NCT05800015.

CT-VCA trial quality

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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.

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