Actively Recruiting
Evaluation of JSKN016 Combination Therapy in Subjects With Advanced Non-Small Cell Lung Cancer: A Phase Ib Study
Led by Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Updated on 2026-03-30
288
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the treatment of advanced non-small cell lung cancer (NSCLC) using the drug JSKN016 in combination with other therapies. This Phase Ib clinical study is conducted in China and includes participants with locally advanced or metastatic NSCLC who are not suitable for radical surgery or radiotherapy. The main goal is to assess both the effectiveness and safety of JSKN016 combined with various treatments in this patient group. Participants receive JSKN016 alongside one of several other drugs including carboplatin, furmonertinib mesylate tablets, ivonescimab, docetaxel, tislelizumab, or pembrolizumab. These medications are given intravenously or orally at specified doses outlined in the study protocol. There are multiple treatment cohorts, each receiving different combinations to evaluate various therapeutic approaches. During the study, participants will undergo regular assessments for tumor response using standardized criteria (RECIST v1.1) and monitoring of any side effects. Safety and plasma drug levels will be measured for up to 24 months. The study also tracks progression-free survival, overall survival, and other clinical outcomes. Participants are expected to be involved in scheduled visits and tests for up to two years to monitor treatment effects and safety.
CONDITIONS
Brief Title
Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign the informed consent form.
- Age 18 to 75 years, male or female.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
- Expected survival of at least 3 months.
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer not suitable for radical surgery or radiotherapy.
- At least one extracranial measurable lesion at baseline per RECIST 1.1 criteria.
- Availability of recent archived or fresh tumor tissue samples.
- Good organ function.
- No current birth plans and agreement to use contraception during the trial.
You will not qualify if you...
- Presence of any small cell carcinoma component in histopathology.
- Other malignant tumors within 5 years prior to enrollment, except certain cured cancers.
- Brainstem, meningeal, spinal cord metastases or compression, leptomeningeal metastases, carcinomatous meningitis, or active brain metastases.
- Tumor invasion or compression of important organs with risk of fistula.
- Inadequate washout of previous therapy before first study dose.
- Gastrointestinal abnormalities with clear clinical symptoms.
- Severe respiratory impairment from lung disease complications.
- Cardiovascular or cerebrovascular diseases or risk factors.
- Prior treatment with topoisomerase I inhibitors, related antibody-drug conjugates, or targeting TROP2 or HER3.
- Previous treatment with docetaxel.
- Uncontrolled infection, immunodeficiency, positive HIV test, or history of AIDS.
- Previous allogeneic bone marrow or organ transplant.
- Known allergy to study drugs or severe allergic reaction to antibody drugs.
- Pregnant or lactating females.
- Local or systemic diseases caused by non-malignant tumors or secondary to tumors that increase medical risk or survival uncertainty, such as tumor leukemia response or cachexia manifestations.
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.
Duration - Up to 24 months
Participants receive JSKN016 in combination with other drugs such as carboplatin, furmonertinib mesilate, ivonescimab, docetaxel, tislelizumab, or pembrolizumab according to their assigned cohort. Treatment is administered intravenously or orally as specified in the protocol.
Visits every 3 weeks for intravenous drugs, daily for oral medications as per protocol
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
L
Li Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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