BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)
18 Years and older, Male and Female
LUN 567 (primary)
NCI-2026-01730
Summary
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
Objectives
This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose
combination) vs durvalumab as consolidation therapy following chemoradiotherapy in
participants with limited-stage (LS)-small-cell lung cancer (SCLC). Participants will
receive concurrent chemotherapy and radiotherapy according to standard guidelines for
treatment of LS-SCLC without progressive disease prior to randomization. Eligible
participants will be randomly assigned to receive either BMS-986489 (atigotatug +
nivolumab as a fixed-dose combination; Arm A) or durvalumab (Arm B) as consolidation
therapy. Atigotatug is a first-in-class, fully human IgG1 antibody being developed for
the treatment of SCLC. Atigotatug specifically binds to fuc-GM1 on the tumor cell.
Nivolumab is a monoclonal anti-PD-1 antibody. Combining atigotatug with another
immunotherapy may provide enhanced antitumor effects.
Eligibility
- 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.
Treatment Sites in Georgia
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