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Taking people in ChinaPhase 2

Tests SKB264 with SKB118 in non-small cell lung cancer

Tests SKB264 with SKB118 in adults with advanced non-small cell lung cancer.

Key facts

Who runs it
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Where
Jilin City and Shanghai, ChinaSee the 2 sites
Trial code
Registry title
SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
People taking part
206 people, planned
Started
7 Aug 2026
Expected to end
Aug 2029
Type of study
Interventional
Treatments tested
  • SKB264+SKB118
Record updated
12 August 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 lung cancer (non-small cell type) that has spread or cannot be removed locally, and that has no EGFR or ALK gene change.

Age
18 to 75 years
Sex
Men and women
Disease stage
Locally advanced or metastatic non-small cell lung cancer (NSCLC), confirmed by tissue or cell examination. At least one measurable tumour lesion. ECOG performance status 0 or 1.
Biomarker or test result
No EGFR sensitizing mutation and no ALK fusion gene. A tumour tissue sample must be provided.

Main reasons for not taking part

  • Small cell lung cancer, neuroendocrine carcinoma or carcinosarcoma components
  • Known spread to the meninges, brainstem or spinal cord, or active spread to the brain or spinal cord (CNS)
  • Active hepatitis B or hepatitis C
  • Earlier organ transplant from a donor or stem cell transplant
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications
  • 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
  • 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

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

  • Jilin Cancer HospitalJilin City, ChinaContact: Haifeng LiuNot yet recruiting
  • Shanghai East Hospital, Tongji UniversityShanghai, ChinaContact: Caicun ZhouTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • SKB264 in combination with SKB118Treatment being tested

    SKB264 at 4 mg/kg combined with SKB118 at 3 mg/kg, 10 mg/kg, 20 mg/kg, or other dose levels

    Treatment: SKB264+SKB118

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests SKB264 with SKB118 in non-small cell 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 NCT07697586, who can take part
Record updated
12 August 2026