BMS-986489 + Nivolumab vs Durvalumab for Small Cell Lung Cancer

(TIGOS-LS Trial)

Recruiting at 12 trial locations

Overseen By Sarah Cannon Development Innovations, LLC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: SCRI Development Innovations, LLC

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Research Team

Melissa Johnson, MD

Principal Investigator

SCRI Development Innovations, LLC

Eligibility Criteria

This trial is for adults with small-cell lung cancer who've finished chemo and radiotherapy without the disease getting worse. They must have good blood and organ function, be willing to use birth control, and have a performance status showing they're mostly active.

Inclusion Criteria

I agree to follow the study's birth control rules.

I may have brain radiation to prevent cancer spread, done 14-42 days before starting the study treatment.

I am fully active or restricted in physically strenuous activity but can do light work.

Treatment Details

Interventions

• BMS-986489 (CAR T-cell Therapy)
• Durvalumab (Checkpoint Inhibitor)

Trial Overview The study compares BMS-986489 (a combination of atigotatug + nivolumab) with durvalumab in patients with limited-stage small-cell lung cancer. It's an open-label trial, meaning everyone knows which treatment they receive.

Participant Groups

Group I: BMS-986489 (atigotatug + nivolumab) Experimental Treatment 1 Intervention

Participants will receive a fixed dose of BMS-986489 (atigotatug + nivolumab) intravenously each cycle. Cycles will be 28 days. Up to 125 participants will be enrolled into this arm.

Group II: Durvalumab Active Control 1 Intervention

Participants will receive standard of care Durvalumab intravenously each cycle. Cycles will be 28 days. Up to 125 participants will be enrolled into this arm.

Who Is Running the Clinical Trial?

SCRI Development Innovations, LLC

Lead Sponsor

Trials

193

Recruited

13,800+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania