drugset / Trial / NCT04253145
Study to Assess Safety,Tolerability,Efficacy of PM01183 and Atezolizumab in Patients w/ Advanced Small Cell Lung Cancer.
NaSingle-groupOpen-labelTreatment
Summary
Prospective, open-label, uncontrolled and multicenter phase I-II study in SCLC patients with ECOG PS 0-1 who have failed one prior platinum-containing line but no more than one chemotherapy-containing line. The study will be divided into two parts: a dose-ranging phase I with escalating doses of PM01183 in combination with a fixed dose of atezolizumab, followed by a single-arm phase II part with expansion at the RD determined during the phase I.
Timeline
- Start
- 2019-12-13
- Primary completion
- 2025-05
- Completion
- 2025-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Lurbinectedin | Other / unclassified | 2.5 mg/m2 | Intravenous |
| Subject | Lurbinectedin | Other / unclassified | 3.2 mg/m2 | Intravenous |
| Subject | Lurbinectedin | Other / unclassified | 3.5 mg/m2 | Intravenous |