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RECRUITING
NCT06030258
PHASE1/PHASE2

IN10018 Combination Therapy in Treatment-naïve ES-SCLC

Sponsor: InxMed (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-10-30

Completion Date

2025-12-24

Last Updated

2025-04-30

Healthy Volunteers

No

Interventions

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

Locations (3)

Shandong Province Cancer Hospital

Jinan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Henan Provincial People's Hospital

Zhengzhou, China