About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- BMS-986489
- Durvalumab
Treatment groups
Sponsors and collaborators
SCRI Development Innovations, LLC
Lead sponsor
Bristol-Myers Squibb
Collaborator