NCT07697586RecruitingPhase 2
SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer
A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 206 (estimated)
- First submitted
- 3 Jul 2026
- Start date
- Aug 2026
- Primary completion date
- Aug 2028
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07697586
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 206
- From Aug 2026 to the primary completion date, Aug 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications.
Other illness
- Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.
- Uncontrolled systemic disease as judged by the investigator.
- Presence of other moderate to severe lung disorders.
- History of haemorrhagic diathesis or coagulopathy and/or clinically significant bleeding symptoms or risks.
- 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.
Other
- Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and/or compression, or active metastases to central nervous system (CNS).
- Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Jilin City | China | Not yet recruiting |
| Shanghai East Hospital, Tongji University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.