NCT05815160

Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy

A Phase 1 Dose-Escalation and Expansion Study to Assess Safety and Preliminary Antitumor Activity of Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of part 1 (dose escalation) of this study is to identify the recommended dose and to characterize the safety and tolerability of Debio 0123 in combination with carboplatin and etoposide. The primary purpose of part 2 (dose expansion) of this study is to characterize the safety and tolerability of Debio 0123 at the recommended dose when administered in combination with carboplatin and etoposide.

Conditions

• Small Cell Lung Cancer Recurrent

Interventions

Type	Name	Description
DRUG	Debio 0123	Administered as capsules.
DRUG	Etoposide	Administered as IV infusion.
DRUG	Carboplatin	Administered as IV infusion.

Timeline

• Start date: 2023-05-02
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-04-18
• Last updated: 2026-03-30

Locations

12 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study