Non-small Lung CancerPhase 2NCT07308106
A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities
A Phase 2 study testing SKB571 for injection in people with Non-small Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The aim of the study to evaluate the safety and efficacy of SKB571 for injection as monotherapy in patients with locally advanced or metastatic Non-Small Cell Lung Cancer with MET abnormalities. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Lung Cancer
- 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
- 70 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2026to 31 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
- Participants with histologically or cytologically confirmed NSCLC.
- Locally advanced or metastatic NSCLC with MET Abnormalities that has progressed after standard therapy.
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose.
- Life expectancy ≥ 3 months as assessed by the investigator.
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- Adequate organ and bone marrow function.
- Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
- Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.
Who cannot join
- Participants with known active central nervous system (CNS) metastasis, and/or carcinomatous meningitis, brainstem metastasis, metastases to spinal cord, or spinal cord compression.
- Participants with other malignant tumors within 3 years prior to the first dose.
- Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
- Presence of severe and/or uncontrolled concomitant diseases.
- Participants with a history of interstitial lung disease (ILD) or a history of non-infectious pneumonitis.
- Clinically severe lung damage due to complications of lung disorder.
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- Risk of esophagotracheal fistula or esophagopleural fistula, or tumor invasion or compression of surrounding vital organs and blood vessels.
- Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1.
- Known active pulmonary tuberculosis.
- Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
- Active hepatitis B and hepatitis C.
- Positive test for human immunodeficiency virus (HIV) or a medical history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- Known allergy or hypersensitivity to SKB571 or its excipients; or a history of severe allergy to other monoclonal antibodies.
- Participants who have undergone major surgery within 4 weeks before the first dose or are expected to require major surgery during the study.
- Serious infection within 4 weeks before the first dose.
- Participants who have received systemic corticosteroid therapy with > 10 mg/day of prednisone or other immunosuppressive drugs within 2 weeks before the first dose of study treatment.
- Participants who have received a live vaccine within 30 days before the first dose, or plan to receive a live vaccine during the study.
- Pregnant or breastfeeding women.
- Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors.
- Any condition that, in the investigator's opinion, interferes with the evaluation of study treatment, participant safety, or interpretation of study results, or any other condition that the investigator deems unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai
Shengxiang Ren, 021-65115006-3051, harry_ren@126.com
About this study
Official title: A Phase II Clinical Study to Evaluate the Safety and Efficacy of SKB571 for Injection as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities
The aim of the study to evaluate the safety and efficacy of SKB571 for injection as monotherapy in patients with locally advanced or metastatic Non-Small Cell Lung Cancer with MET abnormalities. 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
- Non-small Lung Cancer
- Being tested
- SKB571 for injection
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) .
| 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 investigator as per RECIST v1.1.
Measured: Up to 24 months
Secondary outcomes (4)
DCR
Disease control rate (DCR) (assessed by the investigators as per RECIST v1.1)
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
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
OS
Time from start of treatment to death due to any reason.
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 posted29 Dec 2025
- Study start3 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Lung CancerStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308106
- Sponsor's protocol ID
- SKB571-Ⅱ-03
- Status last verified
- May 2026
- First submitted
- 15 Dec 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Safety and Efficacy of SKB571 for Injection as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities
- ClinicalTrials.gov ID
- NCT07308106
- Acronym / sponsor ID
- SKB571-Ⅱ-03
- Conditions
- Non-small Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study to evaluate the safety and efficacy of SKB571 for injection as monotherapy in patients with locally advanced or metastatic Non-Small Cell Lung Cancer with MET abnormalities. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SKB571 monotherapy | Experimental | Drug: SKB571 for injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
- Participants with histologically or cytologically confirmed NSCLC.
- Locally advanced or metastatic NSCLC with MET Abnormalities that has progressed after standard therapy.
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose.
Key exclusion criteria (20 listed)
- Participants with known active central nervous system (CNS) metastasis, and/or carcinomatous meningitis, brainstem metastasis, metastases to spinal cord, or spinal cord compression.
- Participants with other malignant tumors within 3 years prior to the first dose.
- Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
- Presence of severe and/or uncontrolled concomitant diseases.
- Participants with a history of interstitial lung disease (ILD) or a history of non-infectious pneumonitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKB571 for injectionSKB571 for injection is administered every 3 weeks(Q3W) . | Drug | SKB571 monotherapy |
Primary outcome
AE
Time frame: Up to 24 months
Incidence and severity of adverse events (AEs)
ORR
Time frame: Up to 24 months
Objective response rate (ORR) assessed by the investigator as per RECIST v1.1.
4 secondary outcomes
DCR
Time frame: Up to 24 months
DOR
Time frame: Up to 24 months
PFS
Time frame: Up to 24 months
OS
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SKB571 for injection in people with Non-small Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yina Diao (028-67252634, diaoyina@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.