NCT05572476

Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, prospective, open-labeled, 2-arm, randomized non-comparative (2:1) phase II trial assessing the efficacy of lurbinectedin in association with durvalumab

Detailed description

Multicenter, prospective, open-labeled, 2-arm, randomized non-comparative (2:1) phase II trial assessing the efficacy of lurbinectedin in association with durvalumab in pre-treated patients with platinum sensitive extensive stage small-cell lung cancer (SCLC) which failed one prior platinum-containing regimen.

Conditions

• Small Cell Lung Cancer
• Platinum-Sensitive Lung Small Cell Carcinoma
• Extensive-stage Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Association of lurbinectedin and durvalumab	A treatment cycles consists of 3 weeks (i.e. 21 days). Lurbinectedin will be administered by intravenous infusion on Day 1 every 3 weeks. Durvalumab will be administered by intravenous infusion on Day 1 every 3 weeks.
DRUG	Association of carboplatin and etoposide	Treatment will be administered on a 21-days cycle basis up to a maximum of 6 cycles. Carboplatin will be administered by intravenous infusion on Day 1 every 3 weeks. Etoposide will be administered by intravenous infusion on Day 1-3 every 3 weeks

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2022-10-07
• Last updated: 2024-06-05

Locations

1 site across 1 country: France