NCT06030258

IN10018 Combination Therapy in Treatment-naïve ES-SCLC

A Phase Ib/II Clinical Trial to Evaluate the Anti-tumor Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Anti-PD-1/L1 Antibody and Chemotherapy as First-line Treatment in Extensive-stage Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: InxMed (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, Randomized, phase Ib/II clinical study to evaluate the anti-tumor efficacy, safety, tolerability, and PK of IN10018 in combination with anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed as the combination drug) and chemotherapy (platinum and etoposide) as the first-line treatment in Extensive-stage small cell lung cancer (ES-SCLC).

Detailed description

This study consists of 2 parts: 1) Phase Ib-Dose Confirmation part: To assess the PK parameters, safety and recommended phase II dose (RP2D) of IN10018 in combination with anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed as the combination drug), platinum (carboplatin is proposed as the combination drug) and etoposide as the first-line treatment in ES-SCLC. 2) Phase II-Dose Expansion part: To assess the antitumor efficacy, safety and tolerability in the experimental group of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to the control group of Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC.

Conditions

• Small Cell Lung Cancer Extensive Stage

Interventions

Type	Name	Description
DRUG	IN10018	orally taken once daily
DRUG	Tislelizumab	200mg D1, Q3W, intravenously
DRUG	Carboplatin	AUC 5 mg/ml/min, D1, Q3W, intravenously
DRUG	Etoposide	Etoposide 100 mg/m2, D1-D3, Q3W, intravenously

Timeline

• Start date: 2023-10-30
• Primary completion: 2025-12-24
• Completion: 2025-12-24
• First posted: 2023-09-08
• Last updated: 2025-04-30

Locations

3 sites across 1 country: China