Tests JSKN016 combinations in advanced lung cancer
Tests JSKN016 with other drugs in adults with advanced non-small cell lung cancer.
Key facts
- Who runs it
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 288 people, planned
- Started
- 2 Apr 2025
- Expected to end
- 30 Dec 2028
- Type of study
- Interventional, 8 groups
- Treatments tested
- JSKN016
- Carboplatin
- Furmonertinib Mesylate
- Ivonescimab
- Docetaxel
- Tislelizumab
- Pembrolizumab
- Record updated
- 30 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with locally advanced or metastatic non-small cell lung cancer who cannot have radical surgery or radical radiotherapy.
- Age
- 18 to 75 years old.
- Sex
- Men and women can join.
- Disease stage
- Locally advanced or metastatic non-small cell lung cancer, confirmed by tissue or cell tests, that cannot have radical surgery and/or radical radiotherapy. At least one measurable tumor outside the brain.
- Earlier treatment
- People who had topoisomerase I inhibitors, antibody-drug conjugates containing them, or drugs targeting TROP2 or HER3 cannot join. People who had docetaxel cannot join.
- Biomarker or test result
- Recent archived or fresh tumor tissue must be available. No other specific gene change or marker is named.
Main reasons for not taking part
- Any small cell carcinoma component in the tumor
- Active brain metastases, brainstem, meningeal or spinal cord metastases
- Uncontrolled infection, positive HIV test, or history of AIDS
- Earlier bone marrow or organ transplant from another person
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- Voluntarily participate and sign the informed consent form
- Age ≥ 18 years old, ≤ 75 years old, male or female
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
- Expected survival ≥ 3 months
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for radical surgery and/or radical radiotherapy
- At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria
- Recently archived or fresh tumor tissue samples are available
- Have good organ function
- Have no current birth plans and agree to contraception during the trial
Who cannot take part
- Subjects with other malignant tumors within 5 years prior to enrollment, and other tumors have been cured through local therapy, such as cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-primary invasive bladder cancer, and prostate/cervical/breast cancer in situ
- Adequate washout of previous therapy before the first dose
- Prior treatment with topoisomerase I inhibitors (e.g., irinotecan, topotecan), antibody-drug conjugates containing topoisomerase I inhibitors (e.g., DS-8201, HER3-DXd, DS-1062), or targeting TROP2 or HER3
- Previous treatment with docetaxel
- Previous history of allogeneic bone marrow or organ transplantation
- Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs
- Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases
- During the screening period, imaging shows that the tumor invades, compresses, or occurs in the surrounding important organs (such as the heart and pericardium, trachea, esophagus, superior vena cava, etc.) or there is a risk of esophageal tracheal fistula or esophageal pleural fistula
- Presence of clinically severe respiratory impairment caused by pulmonary disease complications
- Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors
- Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS
- Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and/or uncertainty in survival evaluation, such as tumor leukemia response , cachexia manifestations, etc
- Presence of any small cell carcinoma component in histopathology
- Gastrointestinal abnormalities with obvious clinical manifestations
- Pregnant and/or lactating females
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Li ZhangTaking people
About the trial
What the trial wants to find out
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.
The 8 groups in the trial
- Cohort -1A-aTreatment being tested
Receive JSKN016 in combination with carboplatin, administered intravenously at the dosage specified in the protocol.
Treatment: JSKN016 and Carboplatin
- Cohort -1A-bTreatment being tested
Receive JSKN016 in combination with furmonertinib mesilate tablets, administered at the dosage specified in the protocol.
Treatment: JSKN016 and Furmonertinib Mesylate
- Cohort -1BTreatment being tested
Receive JSKN016 in combination with ivonescimab, administered intravenously at the dosage specified in the protocol.
Treatment: JSKN016 and Ivonescimab
- Cohort -2Treatment being tested
Receive JSKN016 in combination with docetaxel, administered intravenously at the dosage specified in the protocol.
Treatment: JSKN016 and Docetaxel
- Cohort -3ATreatment being tested
Receive JSKN016 in combination with tislelizumab，with or without carboplatin, administered intravenously at the dosage specified in the protocol.
Treatment: JSKN016, Carboplatin, and Tislelizumab
- Cohort -3BTreatment being tested
Receive JSKN016 in combination with ivonescimab，with or without carboplatin, administered intravenously at the dosage specified in the protocol.
Treatment: JSKN016, Carboplatin, and Ivonescimab
- Cohort -4Treatment being tested
Receive JSKN016 in combination with pembrolizumab, administered intravenously at the dosage specified in the protocol.
Treatment: JSKN016 and Pembrolizumab
- Cohort -5Treatment being tested
Receive JSKN016 in combination with furmonertinib mesilate tablets, administered at the dosage specified in the protocol.
Treatment: JSKN016 and Furmonertinib Mesylate
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of JSKN016 Combination Therapy in Subjects With Advanced Non-Small Cell Lung Cancer: A Phase Ib Study
- Plain-language title
- Tests JSKN016 combinations in advanced lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06868732, who can take part
- Record updated
- 30 March 2026