Comparing two treatments for extensive-stage small cell lung cancer
A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (BMS-986012+Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide vs Atezolizumab in Combination With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
This study is testing a new treatment combination for extensive-stage small cell lung cancer to see if it works better and is safer than the standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 530 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | Nivolumab, Atezolizumab |
| Locations | 184 sites (Daphne, Alabama and 183 other locations) |
| Trial ID | NCT06646276 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and safety of a new treatment combination, BMS-986489 (which includes BMS-986012 and Nivolumab), with the standard treatment of Atezolizumab combined with Carboplatin and Etoposide for patients with extensive-stage small cell lung cancer. Participants will receive one of the two treatment regimens as their first-line therapy. The study will evaluate how well each treatment works and its safety profile in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with extensive-stage small cell lung cancer who are in good health and can perform normal activities with minimal assistance.
Not a fit: Patients who have previously received treatment for extensive-stage small cell lung cancer or have certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with extensive-stage small cell lung cancer.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this novel combination.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Participants must have diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). * Participants must be Healthy enough to do their normal activities with little or no help based on the ECOG performance scale. * Participants must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system Exclusion Criteria * Participants have already received certain types of treatment for extensive stage small cell lung cancer * Participants have certain health conditions, like spread of small cell lung cancer to the brain that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy * Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
Daphne, Alabama and 183 other locations
- Southern Cancer Center, PC — Daphne, Alabama, United States (Recruiting)
- Local Institution - 0283 — Hot Springs, Arkansas, United States (Completed)
- Florida Cancer Specialists - South — Fort Myers, Florida, United States (Recruiting)
- Mid Florida Hematology and Oncology Center — Orange City, Florida, United States (Recruiting)
- Florida Cancer Specialists - North — St. Petersburg, Florida, United States (Recruiting)
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital — Marietta, Georgia, United States (Recruiting)
- Illinois Cancer Care — Peoria, Illinois, United States (Recruiting)
- Local Institution - 0037 — Minneapolis, Minnesota, United States (Withdrawn)
- University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States (Recruiting)
- Duke Cancer Institute — Durham, North Carolina, United States (Recruiting)
- Sanford Medical Center — Bismarck, North Dakota, United States (Recruiting)
- Local Institution - 0010 — Fargo, North Dakota, United States (Not_yet_recruiting)
- Oncology Hematology Care — Cincinnati, Ohio, United States (Recruiting)
- Sanford Cancer Center — Sioux Falls, South Dakota, United States (Recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- Texas Oncology - Central/South Texas — Austin, Texas, United States (Recruiting)
- Texas Oncology - Northeast Texas — Tyler, Texas, United States (Recruiting)
- Oncology & Hematology Associates of Southwest Virginia, Inc. — Roanoke, Virginia, United States (Recruiting)
- Swedish Cancer Institute - Edmonds — Edmonds, Washington, United States (Recruiting)
- Swedish Medical Center — Seattle, Washington, United States (Recruiting)
- Local Institution - 0079 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (Completed)
- Local Institution - 0077 — Abb, Buenos Aires F.D., Argentina (Active_not_recruiting)
- Local Institution - 0100 — Buenos Aires, Buenos Aires F.D., Argentina (Withdrawn)
- Local Institution - 0080 — Caba, Buenos Aires F.D., Argentina (Active_not_recruiting)
- Local Institution - 0094 — Río Cuarto, Córdoba Province, Argentina (Active_not_recruiting)
- GenesisCare - Campbelltown — Campbelltown, New South Wales, Australia (Recruiting)
- Nepean Hospital — Penrith, New South Wales, Australia (Recruiting)
- Gallipoli Medical Research Ltd — Brisbane, Queensland, Australia (Recruiting)
- Grampians Health — Ballarat Central, Victoria, Australia (Recruiting)
- St. John of God Murdoch Hospital — Murdoch, Western Australia, Australia (Recruiting)
- Medizinische Universität Graz — Graz, Styria, Austria (Recruiting)
- Klinikum Wels-Grieskirchen GmbH — Wels, Upper Austria, Austria (Recruiting)
- Kepler Universitätsklinikum — Linz, Austria (Recruiting)
- Landeskrankenhaus Rankweil — Rankweil, Austria (Recruiting)
- Cliniques universitaires Saint-Luc — Brussels, Bruxelles-Capitale, Région de, Belgium (Recruiting)
- UZ Gent — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
- Vitaz — Sint-Niklaas, Oost-Vlaanderen, Belgium (Recruiting)
- Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman — Liège, Belgium (Recruiting)
- Hospital São Carlos — Fortaleza, Ceará, Brazil (Recruiting)
- Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
- Hospital São Lucas da PUCRS — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
- Instituto de Oncologia Saint Gallen — Santa Cruz do Sul, Rio Grande do Sul, Brazil (Recruiting)
- Clínica de Neoplasias Litoral — Itajaí, Santa Catarina, Brazil (Recruiting)
- Fundação Pio XII - Hospital de Câncer de Barretos — Barretos, São Paulo, Brazil (Recruiting)
- A. C. Camargo Cancer Center — São Paulo, São Paulo, Brazil (Recruiting)
- Local Institution - 0289 — Edmonton, Alberta, Canada (Active_not_recruiting)
- Local Institution - 0290 — Chicoutimi, Quebec, Canada (Active_not_recruiting)
- Local Institution - 0288 — Québec, Quebec, Canada (Active_not_recruiting)
- Local Institution - 0287 — Rimouski, Quebec, Canada (Active_not_recruiting)
- Local Institution - 0086 — Santiago, Santiago Metropolitan, Chile (Active_not_recruiting)
+134 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.