JSKN016 combination therapy for advanced non-small cell lung cancer

Evaluation of JSKN016 Combination Therapy in Subjects With Advanced Non-Small Cell Lung Cancer: A Phase Ib Study

The study will try combining JSKN016 with chemotherapy or targeted antibodies to see if it helps adults whose non-small cell lung cancer is locally advanced or has spread.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 288 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06868732 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed locally advanced or metastatic NSCLC not suitable for curative surgery or radiotherapy, ECOG 0–1, at least one measurable extracranial lesion, available tumor tissue, and adequate organ function are ideal candidates.

Not a fit: Patients with any small cell carcinoma component, recent other active malignancies, poor organ function, ECOG performance status above 1, or inability to attend the Guangzhou site are unlikely to be eligible or to receive benefit.

Why it matters

Potential benefit: If successful, the combination could improve tumor control and extend the time patients live without disease progression compared with current options.

How similar studies have performed: Other trials combining novel targeted agents or antibodies with chemotherapy have shown benefit in select NSCLC subgroups, but JSKN016 itself is an early-stage investigational agent with limited clinical data to date.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

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

Study contacts

• Principal investigator: Li Zhang — Sun Yat-sen University
• Study coordinator: Li Zhang

Conditions Advanced Non-small Cell Lung Cancer