Non-Small-Cell Lung CancerPhase 2KYLIN-2NCT06574347
Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
A Phase 2 study testing Vebreltinib, Osimertinib 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 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic 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, Osimertinib and PLB1004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2024to 31 Jul 2027
- 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 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).
- Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) .
- At least one measurable lesion as defined by RECIST V1.1.
- ECOG performance status 0 to 1.
Who cannot join
- 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
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Jinji Yang, MD, +86-20-83827812, yangjinji@gdph.org.cn
About this study
Official title: A Phase II Study of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.
Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
Read the detailed description
A Multicenter,Randomized,open-label,Phase II Study to Evaluate the Efficacy and Safety of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients with EGFRm+(exon 19 deletion or exon 21 L858R)/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Vebreltinib, Osimertinib, PLB1004
- Keywords
- NSCLC, Lung Cancer, MET Amplification, EGFR L858R, EGFR Exon 19 Deletion, EGFR
- 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
Subjects will receive Vebreltinib orally twice per day (BID).
OsimertinibDrug
Also called AZD9291
Subjects will receive Osimertinib 80mg orally once per day (QD).
PLB1004Drug
Also called Andamertinib
Subjects will receive PLB1004 80mg orally once per day (QD).
| Study group | Role | What they receive |
|---|---|---|
| Vebreltinib 150mg BID+PLB1004 80mg QD | Experimental | Subjects will receive Vebreltinib 150mg orally twice per day (BID) + PLB1004 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. Receives: Drug: Vebreltinib; Drug: PLB1004 |
| Osimertinib 80mg QD | Active comparator | Subjects will receive Osimertinib 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective response rate of the tumor (ORR)
The incidence of confirmed complete response or partial response.
Measured: 2 Years
Secondary outcomes (5)
The disease control rate (DCR)
The incidence of complete response, partial response and stable disease.
Measured: 2 Years
Duration of Response (DoR)
The duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded.
Measured: 2 Years
Progression-free survival (PFS)
Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Measured: 2 Years
Time to Response (TTR)
The period from the date of randomization to the date when the criteria for complete response or partial response was first measured (first record shall prevail).
Measured: 2 Years
Incidence of Treatment-Emergent Adverse Events
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: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start7 Aug 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Jul 2027 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avistone Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi long Wu, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574347
- Sponsor's protocol ID
- PLB1001/PLB1004-NSCLC-II-02
- Acronym
- KYLIN-2
- Status last verified
- Aug 2024
- First submitted
- 25 Aug 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 II Study of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT06574347
- Acronym / sponsor ID
- KYLIN-2 / PLB1001/PLB1004-NSCLC-II-02
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- NSCLC, Lung Cancer, MET Amplification, EGFR L858R, EGFR Exon 19 Deletion, EGFR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Avistone Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 27 Aug 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 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
Detailed description
A Multicenter,Randomized,open-label,Phase II Study to Evaluate the Efficacy and Safety of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients with EGFRm+(exon 19 deletion or exon 21 L858R)/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vebreltinib 150mg BID+PLB1004 80mg QD | Experimental | Drug: Vebreltinib, Drug: PLB1004Subjects will receive Vebreltinib 150mg orally twice per day (BID) + PLB1004 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. |
| Osimertinib 80mg QD | Active comparator | Drug: OsimertinibSubjects will receive Osimertinib 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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).
- Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) .
- At least one measurable lesion as defined by RECIST V1.1.
Key exclusion criteria (3 listed)
- 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, PLB1001Subjects will receive Vebreltinib orally twice per day (BID). | Drug | Vebreltinib 150mg BID+PLB1004 80mg QD |
| OsimertinibAlso: AZD9291Subjects will receive Osimertinib 80mg orally once per day (QD). | Drug | Osimertinib 80mg QD |
| PLB1004Also: AndamertinibSubjects will receive PLB1004 80mg orally once per day (QD). | Drug | Vebreltinib 150mg BID+PLB1004 80mg QD |
Primary outcome
The objective response rate of the tumor (ORR)
Time frame: 2 Years
The incidence of confirmed complete response or partial response.
5 secondary outcomes
The disease control rate (DCR)
Time frame: 2 Years
Duration of Response (DoR)
Time frame: 2 Years
Progression-free survival (PFS)
Time frame: 2 Years
Time to Response (TTR)
Time frame: 2 Years
Incidence of Treatment-Emergent Adverse Events
Time frame: 2 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.
Yi long Wu, MD principal investigator
Guangdong Provincial People's Hospital
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 Vebreltinib, Osimertinib 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 6 inclusion and 3 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 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 Liang Lin (08-10-84148931, linliang@avistonebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The objective response rate of the tumor (ORR) (time frame: 2 Years). 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.