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
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.
• Age between 18 and 75 years old (both 18 and 75 years old included) at the time of signing the informed consent form, applicable to both males and females.
• Locally advanced (stage IIIB/IIIC), metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) confirmed by histology or cytology, which is not eligible for radical surgery or radical chemoradiotherapy.
• Positive for driver gene and having received the first-line targeted therapy approved by the National Medical Products Administration (NMPA).
• Failure of previous tyrosine kinase inhibitor (TKI) treatment and currently having no standard TKI treatment available.
• Positive for PD-L1 (tumor proportion score, TPS ≥ 1%) confirmed by the central laboratory test or local test.
• Being able to provide a qualified test report for positive driver gene, or agreeing to provide a qualified sample for driver gene testing.
• According to the RECIST v1.1 criteria, the subject has at least 1 measurable lesion.
• Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
• Expected survival period ≥ 12 weeks.
⁃ The function of important organs meets the requirements of the protocol.
⁃ Female subjects of childbearing potential, and male subjects whose partners are females of childbearing age, need to adopt a highly effective contraceptive measure during the study treatment period and for at least 6 months after the last administration.
⁃ Voluntarily joining this study, signing the informed consent form, having good compliance, and cooperating with the follow-up.