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No longer recruiting (closed or complete)Last updated: 21 October 2025

R3767-ONC-2266: This study is researching an immunotherapy drug called Fianlimab when given with two other medications (cemiplimab and platinum-doublet chemotherapy) in people with early stage non-small cell lung cancer that can be treated with surgeryA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

R3767-ONC-2266

Clinical summary

Summary

Eligible participants will be randomly allocated to one of three treatment arms.

In Arm A, participants will receive neoadjuvant placebo, cemiplimab and platinum doublet chemotherapy, all administered intravenously (IV) every three weeks. This will be followed by surgery and adjuvant placebo plus cemiplimab.

In Arm B, participants will receive neoadjuvant fianlimab high dose, cemiplimab and platinum doublet chemotherapy, all will be administered via IV every three weeks. This will be followed by surgery and adjuvant fianlinmab high dose plus cemiplimab.

In Arm C, participants will receive neoadjuvant fianlimab low dose, cemiplimab and platinum doublet chemotherapy, all administered via IV every three weeks. This will be followed by surgery and adjuvant fianlimab low dose plus cemiplimab.

Conditions

This trial is treating people with early stage non-small cell lung cancer that is able to be removed with surgery

Eligibility

Inclusion

  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

Exclusion

  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

Inclusion

  • Your cancer has not spread to other parts of the body (localised).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Regeneron Pharmaceuticals

Scientific Title

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

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