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)

Conditions

• Advanced Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• fianlimab — DRUG
  Every three weeks (Q3W) as intravenous (IV) co-infusion
• cemiplimab — DRUG
  Q3W as IV co-infusion
• Placebo — DRUG
  Q3W as IV co-infusion

Study Details

This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab (also called REGN2810), individually called a "study drug" or collectively called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). The aim of the study is to see how effective the combination of fianlimab and cemiplimab is in treating advanced NSCLC, in comparison with cemiplimab by itself. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much study drug is in your blood at different times * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects) * How administering the study drugs might improve your quality of life

Key Dates

Start date

Jun 30, 2023

Status verified

Jan 2026

Primary completion

Mar 11, 2030

Completion

Feb 5, 2032

Study Design

Enrollment

850 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: A: fianlimab+cemiplimab
  Phase 2: fianlimab (HD) Phase 3: fianlimab (chosen dose)
• Experimental: B: fianlimab+cemiplimab
  Phase 2: fianlimab (LD) Phase 3: fianlimab (chosen dose)
• Experimental: C: cemiplimab monotherapy+placebo
  Phase 2 and Phase 3

Primary Outcome Measure

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) [ Time Frame: Up to 136 weeks ]

Locations (23)

Find similar trials in Tucson, AZ

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