Non-Small-Cell Lung CancerPhase 1/2KYLIN-1NCT06343064
Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI
A Phase 1/2 study testing Vebreltinib and PLB1004 in people with Non-Small-Cell Lung Cancer, run by Avistone Biotechnology Co., Ltd. at 1 site in China.
Trial summary
Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- Vebreltinib and PLB1004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2023to 31 Dec 2026
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to sign a written informed consent document.
- Aged at least 18 years old.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB~IV).
- EGFR mutations, including exon 19 deletion and exon 21 L858R.
- C-Met overexpression and/or c-Met amplification confirmed after treatment with EGFR-TKI.
- At least one measurable lesion as defined by RECIST V1.1.
- ECOG performance status 0 to 1.
Who cannot join
- Previous treatment with MET inhibitors or HGF-targeted therapy.
- There are mutations of ALK or ROS1.
- Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.
- Pregnant or nursing women.
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, Shanghai Municipality, 200433
Caichun Zhou, PHD, +86-21-65115006, caicunzhoudr@163.com
About this study
Official title: A Phase Ib/II Study of Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI
Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC
Read the detailed description
Open label, multicenter Phase Ib/II clinical study to evaluate the safety, efficacy, and pharmacokinetics of Vebreltinib in combination with PLB1004 in patients with locally advanced or metastatic non-small cell lung cancer with MET overexpression or MET amplification following EGFR-TKI treatment failure.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Vebreltinib, PLB1004
- Keywords
- Non-Small-Cell Lung Cancer, EGFR, NSCLC, Lung Cancer, MET Amplified, MET Expression
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VebreltinibDrug
Also called Bozitinib, PLB1001
Phase Ib is a dose escalation study, the initial dose of Vebreltinib is 100mg/150mg/200mg,according to the result of Phase Ib, will confirm the RP2D.
PLB1004Drug
Phase Ib is a dose escalation study, the initial dose of PLB1004 is 80mg/160mg,according to the result of Phase Ib, will confirm the RP2D.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib:Vebreltinib 100mg/150mg/200mg BID + PLB1004 80mg/160mg QD | Experimental | In the dose-escalation and dose-expansion phase, patients received oral Vebreltinib 100mg/150mg/200mg BID plus PLB1004 80mg/160mg once daily. Receives: Drug: Vebreltinib; Drug: PLB1004 |
| Phase II:Cohort 1 | Experimental | In phase II-Cohort 1:Failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and c-Met amplification(GCN≥6).Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）. Receives: Drug: Vebreltinib; Drug: PLB1004 |
| Phase II:Cohort 2 | Experimental | In phase II-Cohort 2 :Failed third-generation EGFR inhibitors, c-Met amplification(GCN≥6).Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）. Receives: Drug: Vebreltinib; Drug: PLB1004 |
| Phase II:Cohort 3 | Experimental | In phase II-Cohort 3 :Failed first-generation or second-generation EGFR inhibitors, c-Met over expression.Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）. Receives: Drug: Vebreltinib; Drug: PLB1004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
In phase Ib，Incidence of Treatment-Emergent Adverse Events (TEAEs),
Measured: 3 years
Incidence of dose-limiting toxicities (DLT) as defined in the protocol.
In phase Ib，Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Measured: 28 days
Overall Response Rate (ORR）
In phase II,ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.
Measured: 3 years
Secondary outcomes (4)
Pharmacokinetics of Vebreltinib and PLB1004 : Area under the concentration time curve (AUC)
In phase Ib，Measurement of PK parameters: Area under the concentration time curve (AUC)
Measured: From date of first dose up until 28 days post last dose
Pharmacokinetics of Vebreltinib and PLB1004: Maximum plasma concentration of the study drug (C-max)
In phase Ib，Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)
Measured: From date of first dose up until 28 days post last dose
Pharmacokinetics of Vebreltinib and PLB1004: Time to maximum plasma concentration of the study drug (T-max)
In phase Ib，Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)
Measured: From date of first dose up until 28 days post last dose
Incidence of Treatment-Emergent Adverse Events
In phase II，Incidence of Treatment-Emergent Adverse Events (TEAEs),A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start13 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Avistone Biotechnology 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avistone Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343064
- Sponsor's protocol ID
- PLB1001/PLB1004-NSCLC-Ib/II-01
- Acronym
- KYLIN-1
- Status last verified
- May 2025
- First submitted
- 21 Mar 2024
- Last updated
- 21 May 2025
- 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI
- ClinicalTrials.gov ID
- NCT06343064
- Acronym / sponsor ID
- KYLIN-1 / PLB1001/PLB1004-NSCLC-Ib/II-01
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- Non-Small-Cell Lung Cancer, EGFR, NSCLC, Lung Cancer, MET Amplified, MET Expression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Avistone Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Apr 2024 (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.
Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC
Detailed description
Open label, multicenter Phase Ib/II clinical study to evaluate the safety, efficacy, and pharmacokinetics of Vebreltinib in combination with PLB1004 in patients with locally advanced or metastatic non-small cell lung cancer with MET overexpression or MET amplification following EGFR-TKI treatment failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase Ib:Vebreltinib 100mg/150mg/200mg BID + PLB1004 80mg/160mg QD | Experimental | Drug: Vebreltinib, Drug: PLB1004In the dose-escalation and dose-expansion phase, patients received oral Vebreltinib 100mg/150mg/200mg BID plus PLB1004 80mg/160mg once daily. |
| Phase II:Cohort 1 | Experimental | Drug: Vebreltinib, Drug: PLB1004In phase II-Cohort 1:Failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and c-Met amplification(GCN≥6).Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）. |
| Phase II:Cohort 2 | Experimental | Drug: Vebreltinib, Drug: PLB1004In phase II-Cohort 2 :Failed third-generation EGFR inhibitors, c-Met amplification(GCN≥6).Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）. |
| Phase II:Cohort 3 | Experimental | Drug: Vebreltinib, Drug: PLB1004In phase II-Cohort 3 :Failed first-generation or second-generation EGFR inhibitors, c-Met over expression.Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to understand and willingness to sign a written informed consent document.
- Aged at least 18 years old.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB~IV).
- EGFR mutations, including exon 19 deletion and exon 21 L858R.
- C-Met overexpression and/or c-Met amplification confirmed after treatment with EGFR-TKI.
Key exclusion criteria (4 listed)
- Previous treatment with MET inhibitors or HGF-targeted therapy.
- There are mutations of ALK or ROS1.
- Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.
- Pregnant or nursing women.
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 |
|---|---|---|
| VebreltinibAlso: Bozitinib, PLB1001Phase Ib is a dose escalation study, the initial dose of Vebreltinib is 100mg/150mg/200mg,according to the result of Phase Ib, will confirm the RP2D. | Drug | Phase II:Cohort 1, Phase II:Cohort 2, Phase II:Cohort 3, Phase Ib:Vebreltinib 100mg/150mg/200mg BID + PLB1004 80mg/160mg QD |
| PLB1004Phase Ib is a dose escalation study, the initial dose of PLB1004 is 80mg/160mg,according to the result of Phase Ib, will confirm the RP2D. | Drug | Phase II:Cohort 1, Phase II:Cohort 2, Phase II:Cohort 3, Phase Ib:Vebreltinib 100mg/150mg/200mg BID + PLB1004 80mg/160mg QD |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time frame: 3 years
In phase Ib，Incidence of Treatment-Emergent Adverse Events (TEAEs),
Incidence of dose-limiting toxicities (DLT) as defined in the protocol.
Time frame: 28 days
In phase Ib，Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Overall Response Rate (ORR）
Time frame: 3 years
In phase II,ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.
4 secondary outcomes
Pharmacokinetics of Vebreltinib and PLB1004 : Area under the concentration time curve (AUC)
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of Vebreltinib and PLB1004: Maximum plasma concentration of the study drug (C-max)
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of Vebreltinib and PLB1004: Time to maximum plasma concentration of the study drug (T-max)
Time frame: From date of first dose up until 28 days post last dose
Incidence of Treatment-Emergent Adverse Events
Time frame: 3 years
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 21 May 2025.
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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 1/2 study testing Vebreltinib and PLB1004 in people with Non-Small-Cell Lung Cancer, run by Avistone Biotechnology 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 7 inclusion and 4 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 21 May 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Liang Lin (+86-10-84148931, linliang@avistonebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). (time frame: 3 years). The study lists 3 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 21 May 2025.