Phase II test of SKB571 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 is a multicenter Phase II trial of SKB571 monotherapy in adults with locally advanced or metastatic non-small cell lung cancer. Participants who meet eligibility will receive SKB571 until radiographic disease progression, intolerable toxicity, withdrawal, or other protocol-specified discontinuation. Key eligibility includes age 18–75, ECOG 0–1, at least one measurable lesion per RECIST v1.1, and adequate organ function. The study is sponsored by Sichuan Kelun‑Biotech and is conducted at cancer centers in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects aged 18-75 years at the time of signing the informed consent form
2. Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC .
3. Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
4. Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1.
5. Subjects who are assessed by the investigator to have an expected survival of ≥ 12 weeks.
6. Subjects who have adequate organ function.
7. Subjects who have recovered from all toxicities due to prior therapy .
8. Male and female subjects must agree to use highly effective contraception methods during the study treatment.
9. Subjects who voluntarily sign the informed consent form.

Exclusion Criteria:

1. Subjects with known active or untreated central nervous system (CNS) metastases.
2. Subjects with other malignant tumors within 3 years prior to the first dose.
3. Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.
4. Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.
5. Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage.
6. Subjects with known allergy or hypersensitivity to SKB571 or its excipients.
7. Subjects with clinically severe lung injuries due to pulmonary complications.
8. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
9. Subjects with major surgery within 28 days prior to the first dose.
10. Subjects who have received live vaccines within 30 days prior to the first dose of study treatment, or who are scheduled to receive live vaccines during the study.
11. Subjects who have received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors within 2 weeks prior to the first dose of study treatment or within 5 half-lives of known drug, whichever is longer.
12. Subjects who have received chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of study treatment.
13. Subjects with active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study treatment.
14. Subjects with any disease requiring systemic treatment with corticosteroids (prednisone at doses \> 10 mg/d or similar drugs with equivalent doses) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment.
15. Any condition that, in the opinion of the investigator, will interfere with the assessment of study treatment or the safety of the subject or the interpretation of the study results.

Where it's running

• Henan Cancer Hospital
  Zhengzhou, China Recruiting
• Sun Yat-Sen University Cancer Center
  Guangzhou, China Not yet recruiting

Study contacts

• Study coordinator: Xin Li
• Email: lixin@kelun.com
• Phone: 086-010-58202512

Similar studies

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

• Ivonescimab alone or with carboplatin/pemetrexed for advanced NSCLC with actionable alterations

  This trial tests if ivonescimab, alone or with chemotherapy, can shrink tumors in advanced NSCLC patients who have actionable genomic alterations after prior targeted therapies.

  Recruiting at 2 sites Phase 2 Massachusetts General Hospital · Boston, Massachusetts and 2 other locations · NCT07405190

• Personalized exercise plan for cancer survivors

  This study tests a personalized, physician-guided exercise program for adults who have completed cancer treatment, to see if a safe, structured plan can be implemented in routine care.

  Recruiting Kaohsiung Medical University Chung-Ho Memorial Hospital · Kaohsiung, Taiwan · NCT07751783

• Abdominal pressure device to control breathing during stereotactic radiotherapy for peripheral non-small cell lung cancer

  This project tries an abdominal pressure device to reduce breathing-related tumor movement during stereotactic radiotherapy for people with solitary peripheral non-small cell lung cancer.

  Recruiting Tianjin Medical University Cancer Institute and Hospital · Tianjin · NCT07561567

• Combining nutrition checks and muscle measurements to predict outcomes after lung cancer surgery

  This project will test whether combining nutrition tests and muscle scans can predict recovery, complications, and short-term outcomes in adults having lung cancer surgery.

  Recruiting Ondokuz Mayıs University · Samsun, Samsun · NCT07500376

• SL-28 for Advanced Solid Tumours

  A new allogeneic cell therapy called SL-28 is being tested in adults with advanced solid tumors to see if it is safe and can help shrink tumors.

  Recruiting Phase 1/2 Second Life Therapeutics · Sydney, New South Wales and 2 other locations · NCT07341737

• Support for Veterans with lung cancer.

  This study will test whether weekly phone support from a trained lay health worker can improve quality of life for Veterans who are newly diagnosed with lung cancer or who finished treatment within the past year.

  Recruiting Palo Alto Veterans Institute for Research · Palo Alto, California · NCT07219251

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.