IN10018 Combination Therapy in Treatment-naïve ES-SCLC
NCT06030258 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-04-30
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).
Conditions
- Small Cell Lung Cancer Extensive Stage
Interventions
- DRUG
-
IN10018
orally taken once daily
- DRUG
-
Tislelizumab
200mg D1, Q3W, intravenously
- DRUG
-
AUC 5 mg/ml/min, D1, Q3W, intravenously
- DRUG
-
Etoposide
Etoposide 100 mg/m2, D1-D3, Q3W, intravenously
Sponsors & Collaborators
-
InxMed (Shanghai) Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jun Zhao · Peking University Cancer Hospital & Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-30
- Primary Completion
- 2025-12-24
- Completion
- 2025-12-24
Countries
- China
Study Locations
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