Actively Recruiting
A Study of JS207 (PD-1/VEGF Bispecific Antibody) in Combination With Chemotherapy in Advanced Non-small Cell Lung Cancer
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2025-06-27
42
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of JS207 (PD-1/VEGF Bispecific Antibody) in Combination With Chemotherapy in Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old inclusive at the time of informed consent
- Diagnosed with locally advanced (stage IIIB/IIIC), metastatic, or recurrent non-squamous NSCLC not eligible for surgery or radical chemoradiotherapy
- Positive for driver gene and previously treated with approved first-line targeted therapy
- Experienced failure of prior tyrosine kinase inhibitor (TKI) treatment with no standard TKI options available
- PD-L1 positive with tumor proportion score (TPS) 261%
- Able to provide a qualified test report for positive driver gene or agree to testing
- At least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate organ function as defined by protocol
- Women of childbearing potential and men with partners of childbearing potential agree to use effective contraception during treatment and for 6 months after last dose
- Voluntarily consent to participate and comply with study procedures
You will not qualify if you...
- Presence of neuroendocrine tumor components or squamous cell carcinoma components exceeding 10%
- Known meningeal or symptomatic brain metastases
- Tumors encircling major blood vessels, with necrosis or cavities posing bleeding risk
- Previous immunologically mediated treatment or anti-VEGF pathway drugs
- History or signs of severe bleeding or coagulation disorders
- Gastrointestinal perforation, fistula, or abscess within 6 months or high risk for such conditions
- Serious, unhealed wounds, active ulcers, or untreated fractures
- Uncontrolled hypertension or history of hypertensive crisis/encephalopathy
- Toxicity from prior anti-tumor treatment not recovered to grade 1 or better
- Known allergies to study drugs or history of severe antibody drug allergy
- Active or history of autoimmune disease
- History of immunodeficiency
- Severe infection within 4 weeks prior to first study drug use
- History or evidence of moderate to severe lung diseases affecting function
- Active pulmonary tuberculosis or hepatitis B or C infections
- Diagnosed with other malignancies within 5 years prior to study
- Uncontrolled concurrent diseases or other severe medical or mental illnesses increasing risk or interfering with study results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Guangdong Provicial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
Y
Ying Zhang, Master
CONTACT
H
Huiyu Lan, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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