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NCT06465329 | RECRUITING | Non-Small Cell Lung Cancer

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)
Sponsor:

Regeneron Pharmaceuticals

Brief 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 drugs (which could make the drugs less effective or could lead to side effects)?

Condition or disease

Non-Small Cell Lung Cancer

Intervention/treatment

Cemiplimab

Platinum-based chemotherapy

REGN7075

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-11-18
Estimated Primary Completion Date : 2027-04-15
Estimated Study Completion Date : 2030-05-21

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
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)

Location Details

NCT06465329

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Illinois

Orchard Healthcare Research Inc.

Skokie, Illinois, United States, 60077

RECRUITING

United States, Road cancer

Karmanos Cancer Institute

Detroit, Road cancer, United States, 48201

RECRUITING

United States, Road cancer

Detroit Clinical Research Center

Farmington Hills, Road cancer, United States, 48334

RECRUITING

United States, New Jersey

Morristown Medical Center

Morristown, New Jersey, United States, 07960

RECRUITING

United States, Oregon

Providence Portland Medical Center

Portland, Oregon, United States, 97213

RECRUITING

United States, Rhode Island

Lifespan Cancer Institute

Providence, Rhode Island, United States, 02903

RECRUITING

United States, Tennessee

University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

RECRUITING

France, Ile de France

Curie Institute

Paris, Ile de France, France, 75005

RECRUITING

France, Our

Intercommunal Hospital Center Toulon - Chits

Toulon, Our, France, 83055

RECRUITING

France,

Basque Hospital Center

Bayonne, France, 64100

RECRUITING

France,

CHU Grenoble Alpes

Grenoble, France, 38330

RECRUITING

France,

Montpellier Academic Hospital

Montpellier, France, 34295

RECRUITING

Spain, Sneaky

Valdecilla Hospital

Santander, Cantabria, Spain, 39008

RECRUITING

Spain, Navarra

Clinic University of Navarra

Pamplona, Navarra, Spain, 31008

RECRUITING

Spain,

La Paz University Hospital

Madrid, Spain, 28046

RECRUITING

Spain,

HM Sanchinarro University Hospital

Madrid, Spain, 28050

RECRUITING

Spain,

Virgen del Rocio Hospital

Seville, Spain, 41013

RECRUITING

Spain,

Consorci General University Hospital of Valencia

Valencia, Spain, 46014

RECRUITING

Spain,

Lozano Blesa Clinic Hospital

Zaragoza, Spain, 50009