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

Conditions

• Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• fianlimab — DRUG
  Administered intravenously (IV) every 3 weeks (Q3W)
• cemiplimab — DRUG
  Administered IV Q3W
• Pemetrexed — DRUG
  IV Infusion, Q3W
• Paclitaxel — DRUG
  IV Infusion, Q3W
• Carboplatin — DRUG
  IV Infusion, Q3W
• Cisplatin — DRUG
  IV infusion, Q3W
• Placebo — DRUG
  IV infusion, Q3W

Study Details

This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapy, individually called a "study drug" or collectively called "study drugs". 'Investigational' means that the study drug is not approved for use outside of this study by any Health Authority. Examples of chemotherapy drugs include the following: Paclitaxel plus carboplatin, and Pemetrexed plus cisplatin. The study is being conducted in patients who have advanced non-small cell lung cancer (NSCLC). The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is for treating advanced NSCLC, in comparison with cemiplimab and chemotherapy. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much of each 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

Aug 8, 2023

Status verified

Jan 2026

Primary completion

Jan 16, 2030

Completion

Dec 23, 2031

Study Design

Enrollment

950 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 2 - Arm A
  Randomized 1:1:1 fianlimab (higher dose) + cemiplimab + platinum-doublet chemotherapy
• Experimental: Phase 2 - Arm B
  Randomized 1:1:1 fianlimab (lower dose) + cemiplimab + platinum-doublet chemotherapy
• Experimental: Phase 2 - Arm C
  Randomized 1:1:1 cemiplimab + platinum-doublet chemotherapy + placebo
• Experimental: Phase 3 - Arm A or B
  Randomized 1:1 fianlimab (chosen dose) + cemiplimab + platinum-doublet chemotherapy
• Experimental: Phase 3 - Arm C
  Randomized 1:1 cemiplimab + platinum-doublet chemotherapy + placebo

Primary Outcome Measure

Objective response rate (ORR) as assessed by blinded independent review committee (BICR) using RECIST 1.1 [ Time Frame: Up to 136 Weeks ]

Locations (29)

Find similar trials in Tucson, AZ

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