Actively Recruiting
Phase II Study of JS207 (PD-1/VEGF Bispecific Antibody) Combination Therapies in Patients With Driver Gene-Positive Advanced Non-Small Cell Lung Cancer After TKI Treatment Failure
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2026-05-18
78
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for patients with advanced non-squamous non-small cell lung cancer (NSCLC) who have specific positive driver gene mutations and have not responded to tyrosine kinase inhibitor (TKI) therapy. This phase II clinical trial aims to assess the safety, tolerability, and early effectiveness of combination therapies involving JS207, a PD-1/VEGF bispecific antibody, with other drugs in this patient group. The study plans to enroll approximately 66 to 78 participants. Participants are divided into two groups: Cohort 1 receives JS207 (10 or 15 mg/kg intravenously on day 1) combined with pemetrexed (500 mg/m² IV on day 1) and platinum-based chemotherapy (carboplatin or cisplatin) every three weeks for four cycles. After these cycles, JS207 and pemetrexed continue every three weeks as maintenance until stopping criteria are met. Cohort 2 receives JS207 (10 mg/kg IV on day 1) combined with JS212 (4.2 mg/kg or another selected dose IV on day 1) every three weeks until treatment ends. Participants will undergo regular assessments including evaluations of tumor response, survival, and side effects for up to about 37 months. Researchers will measure objective response rates and other outcomes like progression-free survival and overall survival. Safety and lab tests will also be monitored throughout the study period, with ongoing follow-up to track the effects and tolerability of the treatments.
CONDITIONS
Brief Title
Phase II Clinical Study of JS207 (PD-1/VEGF Bispecific Antibody) Combination Therapies in Patients With Driver Gene-Positive, Advanced Non-Small Cell Lung Cancer After Failure of TKI Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old, inclusive, for both males and females
- Diagnosed with locally advanced (stage IIIB/IIIC), metastatic, or recurrent non-squamous non-small cell lung cancer not eligible for radical surgery or chemoradiotherapy
- Positive for driver gene mutations such as EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, KRAS, HER-2, or EGFR 20 exon insertion
- Previous targeted therapy has failed and no standard targeted treatment is available
- Cohort 1: PD-L1 positive (TPS 61 1%) confirmed; Cohort 2: must provide samples for biomarker testing
- Able to provide qualified test reports or samples for driver gene testing
- At least one measurable lesion according to RECIST v1.1 criteria
- ECOG performance status score between 0 and 1
- Expected survival of at least 12 weeks
- Important organ functions meet protocol requirements
- Agree to effective contraception measures during and after treatment as specified
- Voluntarily consent to participate, comply with study procedures, and follow-up
You will not qualify if you...
- Tumors with neuroendocrine components or squamous cell carcinoma exceeding 10%, symptomatic brain metastasis, meningeal metastasis, or tumors posing bleeding risks
- Prior treatments including immune-mediated therapies, systemic chemotherapy, anti-VEGF, anti-EGFR/HER3 drugs, or certain antibody-drug conjugates (specific to cohort 2)
- History of severe bleeding or coagulation disorders
- Recent gastrointestinal perforation, fistula, or abscess within 6 months or high risk for these conditions
- Serious wounds, active ulcers, or untreated fractures
- Uncontrolled hypertension or history of hypertensive crisis/encephalopathy
- Toxicity from prior cancer treatments not recovered to grade 1 or less
- Allergy to study drugs or related agents
- Active or history of autoimmune or immunodeficiency diseases
- Severe infections within 4 weeks before starting study drugs
- History or suspicion of interstitial lung disease or severe lung conditions
- Active pulmonary tuberculosis, hepatitis B or C infections
- Diagnosis of other malignancies within 5 years prior to study
- Uncontrolled concurrent diseases or severe medical/mental conditions increasing study risks or interfering with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable, until treatment discontinuation criteria are met
Participants receive JS207 in combination with other drugs depending on their cohort. Cohort 1 receives JS207 plus pemetrexed and platinum-based chemotherapy every 3 weeks for 4 cycles, followed by continued JS207 and pemetrexed every 3 weeks until treatment discontinuation criteria are met. Cohort 2 receives JS207 plus JS212 every 3 weeks until treatment termination criteria are met.
Every 3 weeks (in-person) corresponding to each treatment cycle
Trial Site Locations
Total: 1 location
1
Guangdong Provicial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
M
Mei Yue, Master
H
Huiyu Lan, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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