drugset / Trial / NCT04610658
Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC
Phase 1
Terminated
9 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Bristol-Myers Squibb · collabJazz Pharmaceuticals · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a single-arm, phase I/II trial to determine the Maximum Tolerated Dose (MTD), Recommended Phase II Dose (RP2D), and the safety and efficacy of the combination of nivolumab-ipilimumab plus lurbinectedin in patients with relapsed/recurrent small cell lung cancer after progression with first-line, platinum-based chemotherapy
Timeline
- Start
- 2020-11-23
- Primary completion
- 2023-03-24
- Completion
- 2023-03-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | — |
| Subject | Lurbinectedin | Other / unclassified | 1.5 mg/m2 | — |
| Subject | Lurbinectedin | Other / unclassified | 2.6 mg/m2 | — |
| Subject | Lurbinectedin | Other / unclassified | 3.2 mg/m2 | — |
| Subject | Nivolumab | Monoclonal antibody | 360 mg | — |