Home › Trials › NCT06465329

Comparing Cemiplimab with and without an additional cancer treatment for operable lung cancer

A Randomized Phase 2 Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients With Resectable Non-Small Cell Lung Cancer

Phase 2 Interventional Regeneron Pharmaceuticals · NCT06465329

This study tests if adding a new cancer treatment to cemiplimab and chemotherapy helps adults with early-stage lung cancer do better after surgery.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionscemiplimab, chemotherapy, immunotherapy
Locations49 sites (Orange, California and 48 other locations)
Trial IDNCT06465329 on ClinicalTrials.gov

What this trial studies

This study enrolls adult patients with early-stage non-small cell lung cancer (NSCLC) who are scheduled for surgery. It aims to determine if the combination of the immunotherapy drug cemiplimab, chemotherapy, and an additional investigational drug is more effective than cemiplimab plus chemotherapy alone. The study will also evaluate side effects, surgical outcomes, drug levels in the blood, and the body's immune response to the treatments. Participants will be closely monitored throughout the trial to assess these factors.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed stage II to IIIB resectable NSCLC who are eligible for surgery.

Not a fit: Patients with known oncogenic alterations in EGFR or ALK, or those with other malignancies requiring active treatment, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with operable non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise with immunotherapy combined with chemotherapy in lung cancer, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
General Key Inclusion Criteria:

1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
5. Adequate organ and bone marrow function, as described in the protocol

General Key Exclusion Criteria:

1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
2. Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as described in the protocol
3. Presence of grade≥ 2 peripheral neuropathy
4. Another malignancy that is progressing or requires active treatment, as described in the protocol

Arm Specific Exclusion Criteria:

Arm 1:

1. Grade ≥3 hypercalcemia, as defined in the protocol
2. Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
3. Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol

Note: Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Orange, California and 48 other locations

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 Non-Small Cell Lung CancerLung CarcinomaResectable NSCLC
Last reviewed 2026-06-13 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.