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
  Administered per the protocol
• cemiplimab — DRUG
  Administered per the protocol
• Placebo — DRUG
  Administered per the protocol

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

First listed

Mar 27, 2023

Start date

Jun 30, 2023

Status verified

Jun 2026

Primary completion

Sep 28, 2027

Completion

Sep 28, 2027

Study Design

Enrollment

149 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

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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