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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSCRI Development Innovations, LLC

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

250 Participants
are divided into 2 treatment groups

Locations

33
Alabama
Southern Cancer Center36526, Daphne United States
California
Sansum Clinic93105, Santa Barbara United States
Florida
Florida Cancer Specialists - South33901, Fort Myers United States
University of Miami - Sylvester Cancer Center33136, Miami United States

Sponsors and collaborators

SCRI Development Innovations, LLC

Lead sponsor

Bristol-Myers Squibb

Collaborator