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

Launched by REGENERON PHARMACEUTICALS · Nov 29, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for adults with a specific type of lung cancer called resectable non-small cell lung cancer (NSCLC), which means the cancer can be removed by surgery. The researchers want to find out if combining an experimental drug named fianlimab with another drug called cemiplimab and standard chemotherapy is more effective and safe than using cemiplimab and chemotherapy alone before surgery. This study will look at how well the drugs work, any side effects they may cause, and how they affect patients' overall quality of life.

To participate in the trial, patients need to have recently diagnosed, operable stage II to IIIB NSCLC without any spread to other parts of the body. They should be in good health otherwise, with certain test results showing their cancer is suitable for this study. Participants can expect to receive regular health check-ups, and their response to the treatment will be closely monitored. This study is currently recruiting participants, and it's open to adults aged 65 and older, regardless of gender.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Patients with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8
• • 2. For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol
• • 3. 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
• • 4. A patient must have an evaluable Programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) result as defined in the protocol
• • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• • 6. Adequate bone marrow, hepatic and kidney function as defined in the protocol
• Key Exclusion Criteria:
• • 1. Any evidence of locally advanced unresectable or metastatic disease as defined in the protocol
• • 2. Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol
• • 3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection as defined in the protocol
• • 4. 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.
• • 5. Patients with a history of myocarditis
• • Note: Other protocol-defined Inclusion/ Exclusion Criteria apply