Actively Recruiting
A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2026-05-18
864
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination therapy of JS212 with other drugs in patients with advanced lung cancer, including non-small cell lung cancer (NSCLC) and extensive-stage small cell lung cancer (ES-SCLC). This Phase II, open-label, multicenter study aims to assess the response rate, safety, tolerability, and early effectiveness of JS212 combined with JS207, Toripalimab, or JS213, with or without chemotherapy. It focuses on patients who have either failed previous treatments or have not yet received systemic anti-tumor therapy. The study consists of two parts: a safety introduction phase and a clinical expansion phase. JS212 is given by intravenous infusion on Day 1 of each 21-day cycle in all treatment groups. Depending on the group, JS212 is combined with JS207, Toripalimab, or JS213, also given intravenously on Day 1 of each 21-day cycle. Chemotherapy may be added based on safety evaluations. The study includes multiple cohorts to explore different combinations and their safety profiles. Participants will undergo evaluations including tumor response assessments according to standard criteria, safety monitoring, and measurement of drug levels in the blood. Researchers will track outcomes such as objective response rate, progression-free survival, duration of response, disease control rate, overall survival, and adverse events for up to six years. Laboratory tests and immunogenicity assessments will also be conducted. The study lasts several years with ongoing safety and efficacy follow-up.
CONDITIONS
Brief Title
A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old, any gender
- Diagnosis of locally advanced, metastatic, or recurrent non-small cell lung cancer (NSCLC)
- Diagnosis of extensive-stage small cell lung cancer (ES-SCLC)
- At least one measurable lesion according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate function of important organs
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before first treatment and agree to effective contraception until 7 months after last dose
- Male participants with fertile partners must agree to use effective contraception until 4 months after last dose and avoid sperm donation during this time
- Voluntary participation with signed informed consent
You will not qualify if you...
- Tumor confirmed as combined large cell neuroendocrine carcinoma, sarcomatoid lesion, or NSCLC with small cell lung cancer component
- NSCLC with positive driver mutations
- Known meningeal metastasis
- Symptomatic brain metastases
- Uncontrolled pleural or pericardial effusion, or recurrent ascites
- Untreatable spinal cord compression
- Recent significant hemoptysis or tumor bleeding within 1 month before first study drug use (for Cohorts 1 and 4)
- High bleeding risk or tumor invading important organs with risk of perforation or fistula
- Bleeding tendency or severe coagulation dysfunction history
- Recent gastrointestinal perforation, obstruction, fistula, abscess, or active inflammatory bowel disease
- Severe, non-healed wounds, ulcers, or untreated fractures
- Poorly controlled hypertension
- Use of antiplatelet or anticoagulant therapy within 14 days
- Previous permanent discontinuation of similar agents due to adverse events
- Prior immune-mediated treatments (for part Two)
- Use of investigational drugs within 4 weeks or 5 half-lives before study drug
- Enrollment in another clinical study
- Major surgery within 4 weeks
- Local small-scale radiotherapy within 14 days
- Unrecovered toxicity above grade 1 per CTCAE
- Known allergies to study treatments or excipients
- Prior permanent discontinuation of anti-PD-(L)1 therapy due to adverse events
- Long QT or left ventricular ejection fraction under 50%
- History of interstitial lung disease, drug-induced pneumonia, or severe lung diseases
- Severe infection within 4 weeks
- History of immunodeficiency or organ/bone marrow transplantation
- Active pulmonary tuberculosis or hepatitis
- Uncontrolled concurrent diseases
- Diagnosis of other malignant tumors within 5 years
- Pregnancy, breastfeeding, or planning pregnancy during study
- Other conditions deemed inappropriate by investigator
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 - Repeated 21-day cycles until disease progression or discontinuation
Participants receive combination drug therapies involving JS212 and one of JS207, Toripalimab, or JS213 administered by intravenous infusion on Day 1 of each 21-day cycle.
1 visit every 3 weeks for treatment administration
Duration - Up to 6 years
Participants are monitored for safety and long-term outcomes including response rate, progression-free survival, and overall survival for up to 6 years after treatment ends.
Periodic visits as scheduled for assessments
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
Research Team
W
Weilong Ni, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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