Actively Recruiting
BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)
Led by SCRI Development Innovations, LLC · Updated on 2026-04-22
250
Participants Needed
33
Research Sites
390 weeks
Total Duration
On this page
Sponsors
S
SCRI Development Innovations, LLC
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age at the time of informed consent
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed pulmonary small-cell lung cancer
- Limited-stage disease confirmed by PET scan before chemotherapy and radiotherapy
- Completed concurrent chemotherapy (platinum and IV etoposide) and radiotherapy for LS-SCLC without progression within 42 days before randomization
- Prophylactic cranial irradiation completed between 14 and 42 days before randomization, if applicable
- Adequate blood and organ function
- Willing to follow contraceptive requirements during the study
You will not qualify if you...
- Small-cell cancer not originating in the lungs
- Large cell neuroendocrine carcinoma
- Extensive-stage small-cell lung cancer
- Mixed small-cell and non-small-cell lung cancer features
- History of severe allergic reactions to monoclonal antibodies
- Known allergy to any components of atigotatug, nivolumab, or durvalumab
- Grade 2 or higher peripheral neuropathy
- Active or suspected autoimmune diseases, except specific controlled conditions
- Use of chronic systemic corticosteroids or immunosuppressive therapy within 14 days before study treatment
- History of organ or bone marrow transplantation
- History of Grade 2 or higher pneumonitis, except resolved infective pneumonitis
- Significant heart problems or abnormalities within the last 3 months
- Serious or uncontrolled medical disorders
- Other active invasive cancers, unless treated and disease-free for at least 2 years
- Previous systemic treatment for LS-SCLC other than chemoradiotherapy and prophylactic cranial irradiation
- Prior treatment with certain immunotherapies or vaccines targeting T-cell pathways or ganglioside antigens
- Current treatment with immunosuppressive medications
- Live attenuated vaccine within 100 days before study treatment
- Major surgery within 4 weeks before screening
- Unresolved toxicities from prior therapy greater than Grade 1 except alopecia
- Psychological, familial, sociological, or geographical conditions preventing protocol compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
Southern Cancer Center
Daphne, Alabama, United States, 36526
Actively Recruiting
2
Sansum Clinic
Santa Barbara, California, United States, 93105
Actively Recruiting
3
Florida Cancer Specialists - South
Fort Myers, Florida, United States, 33901
Actively Recruiting
4
University of Miami - Sylvester Cancer Center
Miami, Florida, United States, 33136
Active, Not Recruiting
5
Ocala Oncology Center
Ocala, Florida, United States, 34474
Actively Recruiting
6
Florida Cancer Specialists - North
Orange City, Florida, United States, 32763
Actively Recruiting
7
Cancer Care Centers of Brevard
Palm Bay, Florida, United States, 32901
Actively Recruiting
8
Florida Cancer Specialists - East
West Palm Beach, Florida, United States, 33401
Actively Recruiting
9
Piedmont Healthcare - Atlanta
Atlanta, Georgia, United States, 30309
Actively Recruiting
10
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
Actively Recruiting
11
Illinois Cancer Care
Peoria, Illinois, United States, 61615
Actively Recruiting
12
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
13
Baptist Health - Corbin
Corbin, Kentucky, United States, 40701
Actively Recruiting
14
Baptist Health - Lexington
Lexington, Kentucky, United States, 40503
Actively Recruiting
15
Baptist Health - Louisville
Louisville, Kentucky, United States, 40207
Actively Recruiting
16
Minnesota Oncology Hematology
Maple Grove, Minnesota, United States, 55369
Actively Recruiting
17
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
Actively Recruiting
18
White Plains Hospital Physician Associates
White Plains, New York, United States, 10601
Actively Recruiting
19
Carolina Cancer Research Center
Wilson, North Carolina, United States, 27896
Actively Recruiting
20
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
Actively Recruiting
21
Mid Ohio Hem/ Onc dba The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Actively Recruiting
22
Oncology Associates of Oregon (Willamette Valley Cancer Institute and Research Center)
Eugene, Oregon, United States, 97401
Actively Recruiting
23
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
Actively Recruiting
24
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
25
Texas Oncology - West Texas
Amarillo, Texas, United States, 79124
Actively Recruiting
26
Texas Oncology- Austin
Austin, Texas, United States, 78705
Actively Recruiting
27
Texas Oncology - Gulf Coast
Beaumont, Texas, United States, 77702
Actively Recruiting
28
Texas Oncology - DFW
Dallas, Texas, United States, 75246
Actively Recruiting
29
Texas Oncology - Northeast Texas
Denison, Texas, United States, 75020
Actively Recruiting
30
Texas Oncology - San Antonio
San Antonio, Texas, United States, 78240
Actively Recruiting
31
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
32
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
33
Blue Ridge Cancer Center (Oncology & Hematology Associates of Southwest VA)
Salem, Virginia, United States, 24153
Actively Recruiting
Research Team
S
Sarah Cannon Development Innovations, LLC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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