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RecruitingInterventionalPhase 2

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

NCT ID: NCT06465329Sponsor: Regeneron PharmaceuticalsLast updated: 2026-02-12

Summary

This 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)?

Arms & interventions

  • DrugCemiplimab

    Intravenous (IV) infusion administration

  • DrugPlatinum-based chemotherapy

    IV infusion

  • DrugREGN7075

    IV infusion

Outcome measures

Primary

  • Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)

    Time frame: Up to 12 weeks

Secondary

  • Pathologic complete response (pCR) rate as determined by central BIPR

    Time frame: Up to 12 weeks

  • Residual viable tumor (RVT) as determined by central BIPR

    Time frame: Up to 12 weeks

  • Median event-free survival (EFS)

    Time frame: Up to 5 years

  • EFS rate

    Time frame: Up to 5 years

  • Objective response rate (ORR)

    Time frame: Up to 9 weeks

  • Overall survival (OS)

    Time frame: Up to 5 years

  • Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 76 weeks

  • Severity of TEAEs

    Time frame: Up to 76 weeks

  • Incidence of TEAEs leading to death

    Time frame: Up to 76 weeks

  • Incidence of TEAEs leading to treatment discontinuation

    Time frame: Up to 76 weeks

  • Incidence of serious adverse events (SAEs)

    Time frame: Up to 76 weeks

  • Incidence of adverse events of special interest (AESIs)

    Time frame: Up to 76 weeks

  • Incidence of immune-mediated adverse events (imAEs)

    Time frame: Up to 76 weeks

  • Incidence of infusion-related reactions (IRRs)

    Time frame: Up to 76 weeks

  • Incidence of grade ≥3 laboratory abnormalities

    Time frame: Up to 76 weeks

  • Proportion of delayed surgeries due to TEAEs

    Time frame: Up to 76 weeks

  • Proportion of cancelled surgeries due to TEAEs

    Time frame: Up to 76 weeks

  • Incidence of anti-drug antibodies (ADAs) to cemiplimab over time

    Time frame: Up to 67 weeks

  • Titer of ADAs to cemiplimab over time

    Time frame: Up to 67 weeks

  • Incidence of ADAs to novel anti-cancer agents over time

    Time frame: Up to 67 weeks

  • Titer of ADAs to novel anti-cancer agents over time

    Time frame: Up to 67 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (14)

University of California Irvine

Orange, California, 92868

Recruiting

Orchard Healthcare Research Inc.

Skokie, Illinois, 60077

Recruiting

Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting

Detroit Clinical Research Center

Farmington Hills, Michigan, 48334

Recruiting

Morristown Medical Center

Morristown, New Jersey, 07960

Recruiting

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

Recruiting

Providence Portland Medical Center

Portland, Oregon, 97213

Recruiting

University Of Nebraska Medical Center

Portland, Oregon, 97213

Recruiting

Lifespan Cancer Institute

Providence, Rhode Island, 02903

Recruiting

Prairie Lakes Healthcare System

Watertown, South Dakota, 57201

Recruiting

University of Tennessee Medical Center

Knoxville, Tennessee, 37920

Recruiting

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee, 37203

Recruiting

Tennessee Oncology

Nashville, Tennessee, 37203

Recruiting

BRCC/Oncology & Hematology Associates of SW Virginia

Blacksburg, Virginia, 24060

Recruiting