atigotatug/nivolumab (BMS-986489) / BMS - LARVOL DELTA

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BMS-986489 in Chinese Participants With Relapsed/Refractory Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed | Trial completion date: May 2027 ➔ Sep 2026 | Trial primary completion date: May 2027 ➔ Sep 2026

Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS) (clinicaltrials.gov) - P2 | N=250 | Active, not recruiting | Sponsor: SCRI Development Innovations, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

TIGOS-LS, an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab as consolidation therapy following chemoradiotherapy in limited-stage small-cell lung cancer. (ASCO 2026) - P2 | "In a randomized Phase II study in extensive-stage SCLC, adding atigotatug to carboplatin, etoposide, and nivolumab (CE/NIVO) improved median OS vs CE/NIVO alone (15.6 months vs 11.4 months; Kalinka et al...Participants requiring chronic systemic corticosteroids equivalent to >10 mg of prednisone at the time of enrollment are excluded...Secondary endpoints include PFS, objective response rate, clinical benefit rate, disease control rate, duration of response, and safety parameters. TIGOS-LS (NCT06773910) opened to enrollment in March 2025; 232 enrollment slots remain."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

TIGOS Trial: A Randomized, Double-Blind, Phase III Trial of Atigotatug and Nivolumab Fixed-Dose Combination With Chemotherapy Versus Atezolizumab With Chemotherapy as First-Line Therapy in Patients With Extensive-Stage Small Cell Lung Cancer. (PubMed, Clin Lung Cancer) - P3 | "Recruitment is ongoing at 182 sites across 26 countries with an estimated primary completion date of April 2028, with study completion in September 2031."

Clinical • Journal • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BMS-986489 in Chinese Participants With Relapsed/Refractory Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

First in human medical imaging of zirconium-89 labelled anti-fuc-GM1 monoclonal antibody (BMS-986279) in patients with extensive-stage small cell lung cancer (SNMMI 2025) - P2 | ""1801P Expression analysis of Fuc-GM1 ganglioside in first-line therapy for extensive-stage small cell lung cancer (ES-SCLC) with BMS-986012, nivolumab, and carboplatin-etoposide." Annals of Oncology 35 (2024): S1069-S1070. BMS-986279 is suitable for human dosing and proves capable of non-invasive assessment of whole-body fuc-GM1 expression in patients with ES-SCLC. Results suggest tumor penetration of the BMS-986012 labelled monoclonal antibody in lung, liver, and bone lesions."

Clinical • P1 data • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BMS-986489 in Chinese Participants With Relapsed/Refractory Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

The TIGOS trial: A randomized, double-blind phase 3 trial of atigotatug + nivolumab fixed-dose combination with chemotherapy vs atezolizumab with chemotherapy in patients with 1L extensive-stage small cell lung cancer (ES-SCLC). (ASCO 2025) - P3 | " Approximately 530 eligible patients will be randomized 1:1 to receive either atigotatug + nivolumab fixed-dose combination with carboplatin and etoposide Q3W (induction) followed by atigotatug + nivolumab fixed dose combination (maintenance) Q4W or atezolizumab with carboplatin and etoposide Q3W (induction) followed by atezolizumab (maintenance) Q4W. Assessment of pre- and on-treatment changes in biomarkers will be part of an exploratory analysis. This study will be conducted in 180 locations, with a primary completion date expected in April 2028."

Clinical • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

TIGOS-LS, an open-label, randomized study of BMS-986489 vs durvalumab as consolidation therapy following chemoradiotherapy in limited-stage small-cell lung cancer. (ASCO 2025) - P2 | "In a randomized phase II study in extensive-stage SCLC, atigotatug improved median OS when added to carboplatin, etoposide, and nivolumab (CE/NIVO): 15.6 months (95% confidence interval [CI]: 11.3-NE) vs 11.4 months (95% CI: 9.3-16.5) with CE/NIVO alone (Kalinka et al. Enrollment is projected to start in April 2025. Clinical trial information: NCT06773910."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS) (clinicaltrials.gov) - P2 | N=250 | Recruiting | Sponsor: SCRI Development Innovations, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

CA245-0001: A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS). (clinicaltrials.gov) - P3 | N=530 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BMS-986489 in Chinese Participants With Relapsed/Refractory Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS) (clinicaltrials.gov) - P2 | N=250 | Not yet recruiting | Sponsor: SCRI Development Innovations, LLC

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor