A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT05785767Phase 2/3Active, not recruiting
- Lead sponsor
- Regeneron Pharmaceuticals (Industry)
- Enrollment
- 149 (actual)
- Start date
- 30 Jun 2023
- Primary completion
- 28 Sep 2027 (estimated)
- Study completion
- 28 Sep 2027
- Last update posted
- 2 Jul 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 3
Interventions
- fianlimab Drug
- cemiplimab Drug
- Placebo Drug
Conditions and primary outcome
- Advanced Non-Small Cell Lung Cancer
Primary outcome
Objective response rate (ORR) as assessed by blinded independent central review (BICR), using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) (Up to 136 weeks)
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 NCT05785767.
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
- NCT05785767 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.
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