A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer

Phase 1/2 Completed 39 enrolled Salma Sabbour BeyondSpring Pharmaceuticals Inc. · collab Bristol-Myers Squibb · collab Rutgers Cancer Institute of New Jersey · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open-label Phase I/II study, with a dose escalation part (Phase I) and a single-arm part (Phase II), in patients with recurrent SCLC who progressed after first-line platinum-based chemotherapy and who are candidates for second line therapy. No PK evaluation is planned in this study as nivolumab and ipilimumab are unlikely to alter plinabulin's PK, since the route of excretion is different.

Timeline

Start: 2018-09-06
Primary completion: 2023-09-25
Completion: 2024-07-01

Outcome

Missed primary endpoint

paper the trial did not meet the pre-specified target median PFS of 3.5 months. PMID 39173229 ↗

Publications

Malhotra J, Chiappori A, Fujioka N, Hanna NH, Feldman LE, Patel M, Moore D, Chen C, Jabbour SK. Phase I/II trial of plinabulin in combination with nivolumab and ipilimumab in patients with recurrent small cell lung cancer (SCLC): Big ten cancer research consortium (BTCRC-LUN17-127) study. Lung Cancer. 2024 Sep;195:107932. doi: 10.1016/j.lungcan.2024.107932. Epub 2024 Aug 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	240 mg	Intravenous
Subject	Plinabulin	Small molecule	13.5 mg/m2	Intravenous
Subject	Plinabulin	Small molecule	20 mg/m2	Intravenous
Subject	Plinabulin	Small molecule	30 mg/m2	Intravenous