RECRUITING

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)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)?

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

Quick Facts

Study Start:2024-11-18
Study Completion:2030-05-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06465329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
  2. 2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
  3. 3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
  4. 4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
  5. 5. Adequate organ and bone marrow function, as described in the protocol
  1. 1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
  2. 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. 3. Presence of grade≥ 2 peripheral neuropathy
  4. 4. Another malignancy that is progressing or requires active treatment, as described in the protocol

Contacts and Locations

Study Contact

Clinical Trials Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

University of California Irvine
Orange, California, 92868
United States
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077
United States
Prairie Lakes Healthcare System
Watertown, Massachusetts, 57201
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Detroit Clinical Research Center
Farmington Hills, Michigan, 48334
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Lifespan Cancer Institute
Providence, Rhode Island, 02903
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
Tennessee Oncology
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-18
Study Completion Date2030-05-02

Study Record Updates

Study Start Date2024-11-18
Study Completion Date2030-05-02

Terms related to this study

Keywords Provided by Researchers

  • Lung Carcinoma
  • Resectable NSCLC

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer