BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab for Limited-stage Small-cell Lung Cancer
This study is testing two different treatments for limited-stage small-cell lung cancer (SCLC), a type of lung cancer. You would receive either BMS-986489 (a combination of atigotatug and nivolumab) or durvalumab, both given as intravenous infusions (through a vein) once every 4 weeks for up to 2 years. Both BMS-986489 and durvalumab are immunotherapies, meaning they work by helping your body's immune system fight cancer. The main goal is to see which treatment helps people live longer. Researchers will also look at the safety of BMS-986489. You may be able to join if you are at least 18 years old, have limited-stage SCLC, and meet other health criteria.
- Study design
- This is an open-label, randomized study involving about 250 participants. Participants will be randomly assigned to receive one of the two treatments.
- What's involved
- You would receive intravenous infusions of your assigned treatment once every 4 weeks for up to 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your overall survival will be measured for up to 5 years after randomization. This involves follow-up every 8 or 12 weeks depending on when treatment stopped.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06773910
BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)
Recruiting
PHASE2Ages 18+InterventionalTreatmentSCRI Development Innovations, LLCInvestigator-initiated
~250 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:BMS-986489Durvalumab
At a glance
Recruiting sites
33 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the efficacy of BMS-986489 vs durvalumab by Overall Survival (OS).
Measured over From date of randomization up to 5 years. Every 8 weeks for participants who stopped treatment before disease progression and before completing 6 months of treatment and every 12 weeks for participants who stopped treatment before disease progression and
Conditions
Where it's being run
34 sites across 16 statesFlorida6
Texas6
Kentucky3
Ohio3
Virginia3
Illinois2
Tennessee2
Alabama1
Study leadership
- Melissa Johnson, MD · STUDY_CHAIR · SCRI Development Innovations, LLC
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix A)
Histologically or cytologically confirmed pulmonary SCLC, evaluable by RECIST v1.1
Limited-stage (LS) disease as determined by positron emission tomography (PET) scan prior to initiation of chemotherapy and radiation therapy
Completed concurrent chemotherapy and radiotherapy for LS-SCLC without progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (computed tomography \[CT\] scan chest/abdomen/pelvis; Appendix B) within 42 days before date of randomization and first dose of study treatment
Chemotherapy should consist of a platinum and IV etoposide. Participants who received at least 3 cycles of chemotherapy will be eligible to participate.
Radiotherapy should be administered per institutional guidelines
Prophylactic cranial irradiation (PCI) may be delivered at the discretion of the Investigator and institutional guidelines. PCI, if applicable, must be conducted after the end of chemoradiotherapy and completed between 14 and 42 days before date of randomization and first dose of study treatment.
Adequate hematologic and organ function
Willingness to abide by protocol defined contraceptive requirements for the duration of the study.
Exclusion
Small-cell cancer not pulmonary in origin
Large cell neuroendocrine carcinoma
ES-SCLC
Mixed SCLC and NSCLC histologic features; diagnosis of NSCLC; or EGFR-activating, mutation-positive NSCLC that has transformed to SCLC
History of severe hypersensitivity reaction to monoclonal antibodies
Known hypersensitivity to any excipients of atigotatug, nivolumab, or durvalumab
Grade ≥2 peripheral neuropathy by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Active, prior, or suspected autoimmune disease, including autoimmune neurologic disorders such as paraneoplastic syndrome involving the CNS, peripheral sensory/motor nerves, or neuromuscular junction. Exceptions to this criterion include:
Type 1 diabetes mellitus
Hypothyroidism requiring only hormone replacement
Skin disorders not requiring systemic treatment
Autoimmune conditions not expected to recur during the study
Diseases or conditions requiring chronic systemic corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive therapy within 14 days of starting study treatment. Limited-course (\<2 weeks' duration) oral steroids (10 mg prednisone or equivalent) are permitted. Bronchodilators, inhaled or topical steroids, and adrenal replacement steroid doses \>10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
History of solid organ or bone marrow transplantation
History of Grade ≥2 pneumonitis (excepting resolved infective pneumonitis)
Any of the following cardiac criteria, currently or within the last 3 months:
Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third-degree heart block, atrial fibrillation not rate controlled. Certain conditions may be considered through discussion with the Medical Monitor.
Congestive heart failure (New York Heart Association \[NYHA\] \> Grade 2) or classified as Class 3 or 4 by the NYHA Functional Classification (Appendix D)
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, uncontrolled hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval (Appendix E). Certain conditions may be considered through discussion with the Medical Monitor.
Participants with a left ventricular ejection fraction \<55% or the lower limit of normal of the institutional standard
Uncontrolled hypertension, defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg despite optimal medical management
Active coronary artery disease, including unstable or newly diagnosed angina
Myocardial infarction
History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes)
History or current diagnosis of myocarditis
As judged by the Investigator, participants with serious or uncontrolled medical disorders
Presence of other active invasive cancers. Participants with a previously treated malignancy will be eligible to participate if treatment of that malignancy was completed at least 2 years before date of screening and the participants has no evidence of disease. Exceptions to this criterion include appropriately treated basal cell carcinoma of the skin; in situ carcinoma of uterine cervix; localized prostate cancer that has been definitively treated; or other local tumors considered cured by local treatment.
Received sequential chemotherapy and radiotherapy as a definitive treatment for LS-SCLC
Treatment with any of the following:
Any systemic anticancer chemotherapy, small molecule, biologic, or hormonal agent from a previous treatment regimen or clinical study within 21 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment
Wide-field radiotherapy (including therapeutic radioisotopes such as strontium-89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study treatment or has not recovered from side effects of such therapy
Prior systemic treatment for LS-SCLC, with the exception of chemoradiotherapy and PCI
Prior treatment with an anti-PD-1, anti-PD-L1, anti-programmed cell death ligand 2 (anti-PD-L2), anti-CD137, anti-cytotoxic T-lymphocyte associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
Prior treatment with fuc-GM-1 vaccine or targeted agent or similar vaccine targeting ganglioside antigens
Current treatment with immunosuppressive medications
Live attenuated vaccine within 100 days before first dose of study treatment
Major surgery (excluding placement of vascular access) within 4 weeks of date of screening
With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment. Note: Participants with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor or Principal Investigator.
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol
What this trial measures
- Evaluate the efficacy of BMS-986489 vs durvalumab by Overall Survival (OS).From date of randomization up to 5 years. Every 8 weeks for participants who stopped treatment before disease progression and before completing 6 months of treatment and every 12 weeks for participants who stopped treatment before disease progression and
Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause.