A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery

Conditions

• Resectable 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
  Administered IV Q3W
• Paclitaxel — DRUG
  Administered IV Q3W
• Carboplatin — DRUG
  Administered IV Q3W
• Cisplatin — DRUG
  Administered IV Q3W
• Placebo — DRUG
  Administered IV Q3W

Study Details

This study is researching an experimental drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug" or collectively called "study drugs", when combined in this study. The study is being conducted in patients who have resectable stage II to IIIB (N2) non-small cell lung cancer (NSCLC) that can be treated with surgery. The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC. 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 the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) * How administering the study drugs might affect quality of life

Key Dates

Start date

Jul 16, 2024

Status verified

May 2026

Primary completion

Apr 20, 2026

Completion

Nov 4, 2029

Study Design

Enrollment

195 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  Randomized 1:1:1 Neoadjuvant period: placebo + cemiplimab + platinum doublet chemotherapy Adjuvant period: placebo + cemiplimab
• Experimental: Arm B
  Randomized 1:1:1 Neoadjuvant period: fianlimab high dose + cemiplimab + platinum doublet chemotherapy Adjuvant period: fianlimab high dose + cemiplimab
• Experimental: Arm C
  Randomized 1:1:1 Neoadjuvant period: fianlimab low dose + cemiplimab + platinum doublet chemotherapy Adjuvant Period: fianlimab low dose + cemiplimab

Primary Outcome Measure

Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples [ Time Frame: Up to 24 months ]

Locations (8)

Find similar trials in Clermont, FL