JSKN016 combination therapy for advanced non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase Ib study in China tests JSKN016 given together with agents such as carboplatin, furmonertinib, ivonescimab, or docetaxel in adults with locally advanced or metastatic non-small cell lung cancer. Participants must have measurable extracranial disease, adequate organ function, available tumor tissue, and an ECOG performance status of 0–1. The primary objective is to determine the safety profile and early signs of anti-tumor activity of the combination regimens. The trial is conducted at Sun Yat-sen University Cancer Center in Guangzhou and enrolls patients who meet the listed inclusion and exclusion criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily participate and sign the informed consent form.
2. Age ≥ 18 years old, ≤ 75 years old, male or female.
3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
4. Expected survival ≥ 3 months.
5. 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.
6. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
7. Recently archived or fresh tumor tissue samples are available.
8. Have good organ function.
9. Have no current birth plans and agree to contraception during the trial.

Exclusion Criteria:

1. Presence of any small cell carcinoma component in histopathology.
2. 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.
3. Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases.
4. 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.
5. Adequate washout of previous therapy before the first dose.
6. Gastrointestinal abnormalities with obvious clinical manifestations.
7. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
8. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
9. 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.
10. Previous treatment with docetaxel.
11. Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS.
12. Previous history of allogeneic bone marrow or organ transplantation.
13. Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs.
14. Pregnant and/or lactating females.
15. 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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Li Zhang — Sun Yat-sen University
• Study coordinator: Li Zhang
• Email: zhangli@sysucc.org.cn
• Phone: 13902282893

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Imaging study of [68Ga]Ga-DWJ155 in adults with solid tumors

  This trial tests a new radioligand imaging agent, [68Ga]Ga-DWJ155, to see how well it images tumors and how safe it is in adults with advanced solid cancers.

  Recruiting at 2 sites Phase 1 Novartis · Darlinghurst, New South Wales and 1 other locations · NCT07801508

• Long-term survival and AI-based prediction in NSCLC patients treated with immunotherapy

  This study tests whether AI analysis of routine pathology images, along with multi-omics data, can predict long-term survival for people with advanced NSCLC treated with immunotherapy.

  Recruiting Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing · NCT07668037

• Tislelizumab use in European patients with NSCLC or ES-SCLC in routine care

  This study looks at how tislelizumab is used in real-world European patients with advanced NSCLC or extensive-stage SCLC and what outcomes are seen in everyday clinical practice.

  Recruiting at 6 sites BeOne Medicines · Córdoba and 5 other locations · NCT07652736

• Lorlatinib with local consolidation therapy for ALK-positive advanced non-small cell lung cancer

  This trial will test whether adding local consolidation treatments to lorlatinib helps people with ALK-positive advanced non-small cell lung cancer stay progression-free longer.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT07415005

• PF-08634404 plus chemotherapy versus pembrolizumab-based chemotherapy for advanced non-small cell lung cancer

  This will test whether PF-08634404 combined with chemotherapy works better than pembrolizumab plus chemotherapy for adults with locally advanced or metastatic non-small cell lung cancer who have not received prior treatment for their advanced disease.

  Recruiting at 464 sites Phase 3 Pfizer · Bullhead City, Arizona and 483 other locations · NCT07222566

• Firmonertinib versus standard EGFR drugs as first treatment for advanced NSCLC with EGFR PACC mutations

  This trial tests whether daily firmonertinib works better than standard EGFR drugs (osimertinib or afatinib) as the first treatment for people with advanced NSCLC that has EGFR PACC mutations.

  Recruiting at 141 sites Phase 3 ArriVent BioPharma, Inc. · Fullerton, California and 140 other locations · NCT07185997

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.