OncRef

Clinical Trial: 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

Status:

TERMINATED

Phase:

Phase 1

Lead Sponsor:Debiopharm International SA
Information Provided By:Debiopharm International SA
Last Update Posted:2026-05-04

Study Overview

Brief 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.

Official Title

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

Conditions

Small Cell Lung Cancer Recurrent

Intervention / Treatment

  • Drug: Debio 0123
  • Drug: Etoposide
  • Drug: Carboplatin

Other Study ID Numbers

  • Debio 0123-SCLC-104
  • 2024-510980-40-00
  • U1111-1302-8787

Start Date (Actual)

2023-05-02

Primary Completion Date (Actual)

2026-03-09

Study Completion Date (Actual)

2026-03-09

Enrollment (Actual)

34

Study Type

Interventional

Phase

Phase 1