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Testing a new drug combination for lung cancer treatment

A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC

Phase 2 Interventional Regeneron Pharmaceuticals · NCT06161441

This study is testing a new combination of drugs for adults with certain stages of lung cancer to see if it works better than the usual treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, fianlimab, cemiplimab
Locations61 sites (Birmingham, Alabama and 60 other locations)
Trial IDNCT06161441 on ClinicalTrials.gov

What this trial studies

This trial investigates the safety and effectiveness of combining fianlimab with cemiplimab and chemotherapy in adult patients with resectable stage II to IIIB non-small cell lung cancer (NSCLC). Participants will receive these treatments as peri-operative therapy, and the study will assess various outcomes, including side effects, drug levels in the blood, and immune responses. The goal is to determine if this combination works better than the standard treatment of cemiplimab and chemotherapy alone.

Who should consider this trial

Good fit: Ideal candidates are adults with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB NSCLC.

Not a fit: Patients with locally advanced unresectable or metastatic disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with resectable NSCLC.

How similar studies have performed: Other studies have shown promise with similar combinations of immunotherapy and chemotherapy, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Resectable Non-small Cell Lung CancerStage II to IIIBNSCLCNeoadjuvant therapySubsequent adjuvant therapyPeriOperative
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.