SKB264 plus SKB118 in NSCLC (phase 2)

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 open-label, multicenter study in NSCLC uses a dose-escalation and expansion design to evaluate safety, tolerability, and preliminary efficacy of SKB264 in combination with SKB118. Eligible participants have locally advanced or metastatic NSCLC without EGFR mutations or ALK fusions, an evaluable tumor lesion, good performance status, and adequate organ function. The study collects tumor tissue, follows RECIST v1.1 for response assessments, and requires contraception for both sexes during participation. Sites are located in Jilin and Shanghai in China, led by Sichuan Kelun-Biotech Biopharmaceutical and conducted at multiple centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced or metastatic NSCLC
* Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.
* Provide a tumor tissue sample.
* At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
* ECOG performance status of 0 or 1.
* Life expectancy ≥ 12 weeks.
* Adequate bone marrow, liver, kidney, and coagulation function.
* Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.

Exclusion Criteria:

* Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.
* Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and/or compression, or active metastases to central nervous system (CNS).
* Uncontrolled systemic disease as judged by the investigator.
* Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.
* Presence of other moderate to severe lung disorders.
* History of haemorrhagic diathesis or coagulopathy and/or clinically significant bleeding symptoms or risks.
* Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications.
* Active hepatitis b or hepatitis c or co-infection with HBV and HCV.
* Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.
* Known hypersensitivity to the study drug or any of its components.
* Pregnant or lactating women.

Where it's running

• Shanghai East Hospital, Tongji University
  Shanghai, China Recruiting
• Jilin Cancer Hospital
  Jilin City, China Not yet recruiting

Study contacts

• Study coordinator: Yan Qing Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
• Email: qingyan@kelun.com
• Phone: 028-67255480

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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.