Lung Cancer (Non-Small Cell)Phase 2NCT07230405
A Phase II Study of SKB571 in Patients With Lung Cancer
A Phase 2 study testing SKB571 for injection in people with Lung Cancer (Non-Small Cell), run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This is a multicenter, phase II study. The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of SKB571 in patients with advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer (Non-Small Cell)
- What is being tested?
- SKB571 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 2 sitesChina
- Study dates
- 19 Jan 2026to 19 Jan 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18-75 years at the time of signing the informed consent form
- Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC .
- Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
- Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1.
- Subjects who are assessed by the investigator to have an expected survival of ≥ 12 weeks.
- Subjects who have adequate organ function.
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- Subjects who have recovered from all toxicities due to prior therapy .
- Male and female subjects must agree to use highly effective contraception methods during the study treatment.
- Subjects who voluntarily sign the informed consent form.
Who cannot join
- Subjects with known active or untreated central nervous system (CNS) metastases.
- Subjects with other malignant tumors within 3 years prior to the first dose.
- Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.
- Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.
- Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage.
- Subjects with known allergy or hypersensitivity to SKB571 or its excipients.
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- Subjects with clinically severe lung injuries due to pulmonary complications.
- History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
- Subjects with major surgery within 28 days prior to the first dose.
- 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.
- 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.
- Subjects who have received chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of study treatment.
- Subjects with active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study treatment.
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Sun Yat-Sen University Cancer Center
Guangzhou
Li Zhang, 086-020-87343458, zhangli@sysucc.org.cn
- Recruiting
Henan Cancer Hospital
Zhengzhou
Qiming Wang, 086-0371-65588421, qimingwang1006@126.com
About this study
Official title: A Phase II Study to Evaluate the Safety and Efficacy of SKB571 in Patients With Advanced Non-small Cell Lung Cancer
This is a multicenter, phase II study. The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of SKB571 in patients with advanced non-small cell lung cancer. Eligible subjects will receive SKB571 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
- Conditions
- Lung Cancer (Non-Small Cell)
- Being tested
- SKB571 for injection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB571 for injectionDrug
SKB571 for injection is administered every 3 weeks(Q3W) until radiographic disease progression,intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| SKB571 monotherapy | Experimental | Not described Receives: Drug: SKB571 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Incidence and severity of adverse events (AEs)
Measured: Up to 24 months
ORR
Objective response rate (ORR) (assessed by the investigators as per RECIST v1.1)
Measured: Up to 24 months
Secondary outcomes (4)
PFS
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Measured: Up to 24 months
DOR
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Measured: Up to 24 months
OS
Time from start of treatment to death due to any reason.
Measured: Up to 24 months
DCR
Disease control rate (DCR) (assessed by the investigators as per RECIST v1.1)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start19 Jan 2026
- Primary completion19 Jan 2028 (estimated)
- Study completion19 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Non-Small Cell)Studies of the same condition, open and under way.
- More trials run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 295 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230405
- Sponsor's protocol ID
- SKB571-II-02
- Status last verified
- May 2026
- First submitted
- 13 Nov 2025
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No