RecruitingPhase 2NCT06773910

BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)

An Open-label, Randomized Study of BMS-986489 (Atigotatug + Nivolumab Fixed-dose Combination) vs Durvalumab as Consolidation Therapy Following Chemoradiotherapy in Limited-stage Small-cell Lung Cancer (TIGOS-LS)


Sponsor

SCRI Development Innovations, LLC

Enrollment

250 participants

Start Date

Mar 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab in limited-stage (LS)-small-cell lung cancer (SCLC) participants. The main goals of this study are to: * Evaluate the efficacy of BMS-986489 vs durvalumab * Evaluate the safety profile of BMS-986489


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination immunotherapy (BMS-986489, which combines two immune-boosting drugs) against a standard immunotherapy (durvalumab) in people with limited-stage small cell lung cancer (LS-SCLC) — a fast-growing type of lung cancer that has not spread widely. Participants have already completed their standard chemotherapy and radiation without the cancer getting worse. **You may be eligible if...** - You are 18 years or older - You have small cell lung cancer that is limited-stage (contained to one area of the chest) - You recently finished chemotherapy (platinum + etoposide) and chest radiation without your cancer progressing - You are in good general health and able to perform daily activities (ECOG 0 or 1) **You may NOT be eligible if...** - Your cancer has progressed during chemotherapy or radiation - You have significant health problems that would make immunotherapy unsafe - You have had prior immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBMS-986489

BMS-986489 (fixed dose combination of atigotatug + nivolumab) will be administered as an intravenous infusion to be given once every 4 weeks for up to 2 years.

DRUGDurvalumab

Durvalumab will be administered as a fixed dose intravenous infusion to be given once every 4 weeks for up to 2 years.


Locations(33)

Southern Cancer Center

Daphne, Alabama, United States

Sansum Clinic

Santa Barbara, California, United States

Florida Cancer Specialists - South

Fort Myers, Florida, United States

University of Miami - Sylvester Cancer Center

Miami, Florida, United States

Ocala Oncology Center

Ocala, Florida, United States

Florida Cancer Specialists - North

Orange City, Florida, United States

Cancer Care Centers of Brevard

Palm Bay, Florida, United States

Florida Cancer Specialists - East

West Palm Beach, Florida, United States

Piedmont Healthcare - Atlanta

Atlanta, Georgia, United States

Illinois Cancer Specialists

Arlington Heights, Illinois, United States

Illinois Cancer Care

Peoria, Illinois, United States

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Baptist Health - Corbin

Corbin, Kentucky, United States

Baptist Health - Lexington

Lexington, Kentucky, United States

Baptist Health - Louisville

Louisville, Kentucky, United States

Minnesota Oncology Hematology

Maple Grove, Minnesota, United States

Missouri Cancer Associates

Columbia, Missouri, United States

White Plains Hospital Physician Associates

White Plains, New York, United States

Carolina Cancer Research Center

Wilson, North Carolina, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Mid Ohio Hem/ Onc dba The Mark H Zangmeister Center

Columbus, Ohio, United States

Oncology Associates of Oregon (Willamette Valley Cancer Institute and Research Center)

Eugene, Oregon, United States

Tennessee Cancer Specialists

Knoxville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Texas Oncology - West Texas

Amarillo, Texas, United States

Texas Oncology- Austin

Austin, Texas, United States

Texas Oncology - Gulf Coast

Beaumont, Texas, United States

Texas Oncology - DFW

Dallas, Texas, United States

Texas Oncology - Northeast Texas

Denison, Texas, United States

Texas Oncology - San Antonio

San Antonio, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Blue Ridge Cancer Center (Oncology & Hematology Associates of Southwest VA)

Salem, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06773910


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