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OncoMatch/Clinical Trials/NCT06465329

A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)

Is NCT06465329 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Cemiplimab and Platinum-based chemotherapy for non-small cell lung cancer.

Phase 2RecruitingRegeneron PharmaceuticalsNCT06465329Data as of Jun 2026Location: International · 6 countries

Treatment: Cemiplimab · Platinum-based chemotherapy · REGN7075This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer for whom surgery is planned. The aim is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug. The study is also looking at several other research questions, including: * What are the side effects associated with the investigational treatments in comparison to the control treatment? * Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed? * How much of the study drug(s) are in the blood at a given time? * Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)?

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Cemiplimab

Other

Platinum-based chemotherapyREGN7075

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Excluded: EGFR oncogenic alteration

Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) ... in the tumor prior to randomization

Excluded: ALK oncogenic alteration

Presence of known oncogenic alterations in ... anaplastic lymphoma kinase (ALK) in the tumor prior to randomization

Disease stage

Required: Stage II, IIIA, IIIB (N2)

stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic anti-cancer therapy

Lab requirements

Blood counts

Adequate organ and bone marrow function, as described in the protocol

Kidney function

Adequate organ and bone marrow function, as described in the protocol

Liver function

Adequate organ and bone marrow function, as described in the protocol

Adequate organ and bone marrow function, as described in the protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California Irvine · Orange, California
  • Orchard Healthcare Research Inc. · Skokie, Illinois
  • Karmanos Cancer Institute · Detroit, Michigan
  • Detroit Clinical Research Center · Farmington Hills, Michigan
  • Morristown Medical Center · Morristown, New Jersey

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06465329 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Are patients with EGFR alterations eligible?

No. EGFR oncogenic alteration is an exclusion criterion.

Are patients with ALK alterations eligible?

No. ALK oncogenic alteration is an exclusion criterion.

What disease stage is eligible?

Stage II or IIIA or IIIB (N2) is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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