Actively Recruiting
JS207Combined With Chemotherapy in First-line Treatment of Advanced NSCLC
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2025-07-04
84
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study targets patients with in first-line treatment of advanced NSCLC， enrolling 60-84 participants. Patients will receive Arm 1: JS207 (10 mg/kg or 15 mg/kg, IV, D1) + Pemetrexed (500 mg/m2 IV, D1) + a platinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1), Q3W, for 4 cycles followed by JS207 (10 mg/kg or 15 mg/kg, IV, D1) + pemetrexed (500 mg/m2 IV, D1), Q3W, until meeting the treatment withdrawal criteria. Arm 2: JS207 (10 mg/kg or 15 mg/kg, IV, D1) + Paclitaxel (175 mg/m2 IV, D1) + a platinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1), Q3W, for 4 cycles followed by JS207 (10 mg/kg or 15 mg/kg, IV, D1), Q3W, until meeting the treatment withdrawal criteria.The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.
CONDITIONS
Official Title
JS207Combined With Chemotherapy in First-line Treatment of Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old at the time of signing the informed consent
- Diagnosed with locally advanced (stage IIIB/IIIC), metastatic, or recurrent non-small cell lung cancer not suitable for radical surgery or chemoradiotherapy
- No prior systemic antitumor therapy for metastatic or recurrent NSCLC; at least 6 months since last adjuvant/neoadjuvant/consolidation therapy if applicable
- Tissue samples available for PD-L1 testing, preferably new samples
- At least one measurable lesion based on RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected survival of 12 weeks or longer
- Adequate organ function as required by the protocol
- Use of highly effective contraception during treatment and for at least 6 months after last dose for females of childbearing potential and male partners
- Willing to voluntarily participate, sign informed consent, comply with study procedures, and attend follow-ups
You will not qualify if you...
- Presence of combined neuroendocrine components such as small cell lung cancer or large cell neuroendocrine carcinoma
- Previous treatment with immunologically mediated therapies or drugs targeting the anti-VEGF pathway as listed in the protocol
- Obvious bleeding tendency or history of severe coagulation dysfunction
- Gastrointestinal perforation, intra-abdominal fistula, or abscess within 6 months before first treatment, or high risk for these conditions
- Serious, unhealed or ruptured wounds, active ulcers, or untreated fractures
- Uncontrolled hypertension or history of hypertensive crisis or encephalopathy
- Toxicity from previous anti-tumor treatment not recovered to grade 1 or lower per CTCAE
- Known allergy to the investigational drug, pemetrexed, platinum drugs, or antibody drugs with grade 3 or higher allergy history
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shandong First Medical University Affiliated Neoplasm Hospital
Jinan, Shandong, China, 250117
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
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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