RecruitingPhase 2NCT06868836

A Study of JS207 (PD-1/VEGF Bispecific Antibody) in Combination With Chemotherapy in Advanced Non-small Cell Lung Cancer

A Phase II Study of JS207 (PD-1/VEGF Bispecific Antibody) in Combination With Pemetrexed and Platinum in Advanced Non-small Cell Lung Cancer With Actionable Genomic Alterations and TKI Therapy Failure


Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Enrollment

42 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study targets patients with advanced NSCLC driven with positive driver genes who have failed TKI treatment, enrolling 36-42 participants. Patients will receive JS207 (10 or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) + platinum-based chemotherapy (carboplatin AUC5 or cisplatin 75 mg/m², d1) every 3 weeks for 4 cycles. Afterward, JS207 and pemetrexed will continue as maintenance therapy until discontinuation criteria are met. The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination treatment — a drug called JS207 (which targets two cancer-related proteins at once) paired with chemotherapy — for people with advanced lung cancer that has come back or spread. **You may be eligible if...** - You are between 18 and 75 years old - You have a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that is advanced, has spread, or has returned - Your lung cancer cannot be treated with surgery or radiation alone - Your tumor has a specific genetic mutation ("driver gene") and your cancer stopped responding to targeted therapy (TKI drugs) - A lab test shows your tumor has a protein called PD-L1 (score of 1% or more) - You are in generally good health and can perform daily activities **You may NOT be eligible if...** - You have small cell lung cancer or squamous cell cancer components - You have cancer in the brain that is causing symptoms - You have a history of autoimmune disease or a weakened immune system - You have active tuberculosis, hepatitis B, or hepatitis C - You have been diagnosed with another cancer in the past 5 years - You have uncontrolled high blood pressure or a history of severe bleeding 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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Interventions

DRUGJS207

JS207 (10 mg/kg or 15 mg/kg, IV, d1)

DRUGPemetrexed

Pemetrexed (500 mg/m², IV, d1)

DRUGCarboplatin or cisplatin

Platinum-based chemotherapy (carboplatin: AUC5, d1 or cisplatin 75 mg/m², d1) every 3 weeks (Q3W) for a total of 4 cycles


Locations(1)

Guangdong Provicial People's Hospital

Guangzhou, Guangdong, China

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NCT06868836


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