Last updated 25 days ago

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

180 patients around the world

Available in Chile

Regeneron Pharmaceuticals

3Research sites

180Patients around the world

This study is for people with

Lung cancer

Non-small cell lung carcinoma

From 18 Years

All Gender

: Patients with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8.
For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol.
All patients must have disease status showing no evidence of distant metastases documented by a complete physical examination and imaging studies performed within 4 weeks prior to randomization as defined in the protocol.
A patient must have an evaluable Programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) result as defined in the protocol.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate bone marrow, hepatic and kidney function as defined in the protocol.

: Any evidence of locally advanced unresectable or metastatic disease as defined in the protocol.
Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol.
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection as defined in the protocol.
Treatment with anti-cancer therapy including immunotherapy, chemotherapy, radiotherapy, or biological therapy in the 3 years prior to randomization. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
Patients with a history of myocarditis.

Orlandi Oncología

Recruiting

General Salvo 159, Providencia, Región Metropolitana, Santiago, 7500713

Clínica Santa María

Recruiting

Bellavista 0415, 7520349 Providencia, Región Metropolitana, Chile

Oncocentro APYS - Valparaíso

Recruiting

Avenida La Marina 1702, Viña del Mar, Valparaíso

SponsorRegeneron Pharmaceuticals

Conditions

Non-small cell lung carcinoma

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06161441