Actively Recruiting
Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC
Led by Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Updated on 2026-03-30
288
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase Ib clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016 in combination therapy. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.
CONDITIONS
Official 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 surgery or radical radiotherapy.
- At least one measurable lesion outside the brain at baseline according to RECIST 1.1.
- Availability of recent archived or fresh tumor tissue samples.
- Good organ function.
- No current plans for pregnancy and agree to use contraception during the trial.
You will not qualify if you...
- Presence of any small cell carcinoma component.
- Other malignant tumors within 5 years prior to enrollment, except certain cured cancers.
- Brainstem, meningeal, spinal cord metastases or active brain metastases.
- Tumor invasion or compression of critical organs or risk of fistula.
- Inadequate washout from previous therapies before first dose.
- Gastrointestinal abnormalities with clear symptoms.
- Severe respiratory impairment from lung disease complications.
- Cardiovascular and cerebrovascular diseases or risk factors.
- Prior treatment with topoisomerase I inhibitors, antibody-drug conjugates targeting TROP2 or HER3, or docetaxel.
- Uncontrolled infection, immunodeficiency, HIV positive, or AIDS history.
- Previous allogeneic bone marrow or organ transplant.
- Known allergy to study drug components or severe allergic reactions to antibody drugs.
- Pregnancy or breastfeeding.
- Non-malignant tumor-related diseases or symptoms causing higher medical risks or survival uncertainty.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
L
Li Zhang
CONTACT
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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