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

Recruiting now · Phase 2

Conditions studied: Limited Stage Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT06773910

Run by

SCRI Development Innovations, LLC

People needed

250

Starts

2025-03-11

Expected to finish

2032-09-01

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Blue Ridge Cancer Center (Oncology & Hematology Associates of Southwest VA) — Salem, Virginia, United States (enrolling)
• Sansum Clinic — Santa Barbara, California, United States (enrolling)
• Florida Cancer Specialists - South — Fort Myers, Florida, United States (enrolling)
• Southern Cancer Center — Daphne, Alabama, United States (enrolling)
• Ocala Oncology Center — Ocala, Florida, United States (enrolling)
• Florida Cancer Specialists - North — Orange City, Florida, United States (enrolling)
• Cancer Care Centers of Brevard — Palm Bay, Florida, United States (enrolling)
• Florida Cancer Specialists - East — West Palm Beach, Florida, United States (enrolling)
• Piedmont Healthcare - Atlanta — Atlanta, Georgia, United States (enrolling)
• Illinois Cancer Specialists — Arlington Heights, Illinois, United States (enrolling)
• Illinois Cancer Care — Peoria, Illinois, United States (enrolling)
• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States (enrolling)
• Baptist Health - Corbin — Corbin, Kentucky, United States (enrolling)
• Baptist Health - Lexington — Lexington, Kentucky, United States (enrolling)
• Baptist Health - Louisville — Louisville, Kentucky, United States (enrolling)
• Minnesota Oncology Hematology — Maple Grove, Minnesota, United States (enrolling)
• Missouri Cancer Associates — Columbia, Missouri, United States (enrolling)
• White Plains Hospital Physician Associates — White Plains, New York, United States (enrolling)
• Carolina Cancer Research Center — Wilson, North Carolina, United States (enrolling)
• Oncology Hematology Care — Cincinnati, Ohio, United States (enrolling)
• Mid Ohio Hem/ Onc dba The Mark H Zangmeister Center — Columbus, Ohio, United States (enrolling)
• Oncology Associates of Oregon (Willamette Valley Cancer Institute and Research Center) — Eugene, Oregon, United States (enrolling)
• Tennessee Cancer Specialists — Knoxville, Tennessee, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Texas Oncology - West Texas — Amarillo, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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