RecruitingPhase 1Phase 2NCT06030258

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

Sponsor

InxMed (Shanghai) Co., Ltd.

Enrollment

120 participants

Start Date

Oct 30, 2023

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Cancer Extensive Stage

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination (IN10018 with standard chemotherapy and immunotherapy) for people newly diagnosed with extensive-stage small cell lung cancer — a fast-growing type of lung cancer that has spread beyond the chest. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with extensive-stage small cell lung cancer (confirmed by biopsy) - You have not yet received any treatment for this cancer - You are generally in good health (able to care for yourself) - Your heart, liver, kidneys, and blood counts are functioning adequately **You may NOT be eligible if...** - The cancer has spread to the brain or spinal cord fluid - You have fluid build-up around the heart, lungs, or abdomen causing symptoms - You have an active autoimmune disease - You have received a transplant (organ or bone marrow) - You have another active cancer diagnosed within the past 3 years - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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