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Ifebemtinib + Tislelizumab + Chemotherapy in First-line ES-SCLC
NCT06030258Phase 2
Key facts
- Status
- Recruiting
- Start
- Oct 2023
- Primary completion
- Dec 2025
- Countries
- 1
- Sponsor
- InxMed
- Modality
- Small Molecules
- Drugs
- ifebemtinib
- Conditions
- small cell lung cancer (SCLC)
01
Overview
Phase 2, randomised, open-label trial of ifebemtinib in small cell lung cancer (SCLC) (2 arms), sponsored by InxMed. Primary endpoints: Recommended Phase II Dose up to 3 years and Progression-Free Survival (BICR) up to 3 years. Started Oct 2023; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
IN10018 + Tislelizumab + Chemo
IN10018 (Ifebemtinib) + Tislelizumab + Carboplatin + Etoposide
Tislelizumab + Chemo
Tislelizumab + Carboplatin + Etoposide
03
Who it enrols
Adult patients (18-75 years) with histologically confirmed extensive-stage small cell lung cancer (ES-SCLC) who have not received prior systemic therapy for ES-SCLC. Patients must have measurable disease, ECOG 0-1, and adequate organ function.
04
Endpoints
Primary
Recommended Phase II Dose
Progression-Free Survival (BICR)
Secondary
Progression-Free Survival (Investigator)
Objective Response Rate
Duration of Objective Response
Disease Control Rate
Overall Survival
Number of patients with adverse events
Area Under the Curve
Maximum Plasma Concentration
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