Non-Small-Cell Lung CancerPhase 3KYLIN-3NCT06970782
Vebreltinib Plus PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFRm, MET+, Locally Advanced or Metastatic NSCLC Following EGFR-TKI Failure
A Phase 3 study testing Vebreltinib, PLB1004 and Pemetrexed plus Carboplatin or Cisplatin in people with Non-Small-Cell Lung Cancer, run by Avistone Biotechnology Co., Ltd..
Trial summary
Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure 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, PLB1004 and Pemetrexed plus Carboplatin or Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2025to 31 Dec 2028
- Phase
- Phase 3
- 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).
- 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.
- Before randomization, patients did not recover from any toxicity and/ or complications of previous chemotherapy, surgery, radiotherapy and other anti-cancer treatments, that is, did not fall to grade 1 or lower (National Cancer Research Common Toxicity Criteria for Adverse Events [NCI-CTCAE] v5.0), except for hair loss and irrecoverable permanent radiation damage.
- Major surgery or had significant traumatic injury within 4 weeks prior to the first dose of the investigational product.
- Pregnant or nursing women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Controlled, Open Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure
Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure
Read the detailed description
A Randomized, Controlled, Open Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Vebreltinib, PLB1004, Pemetrexed plus Carboplatin or Cisplatin
- 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 Enteric-coated Capsule orally twice per day (BID).
PLB1004Drug
Also called Andamertinib
Subjects will receive PLB1004 80mg orally once per day (QD).
Pemetrexed plus Carboplatin or CisplatinDrug
Subjects randomized to the control group received pemetrexed 500 mg/m² + platinum-based chemotherapy (carboplatin AUC 5 or cisplatin 75 mg/m²) via intravenous infusion for 4-6 cycles (determined by the investigator) as initial therapy, followed by pemetrexed maintenance therapy (500 mg/m²) until disease progression, intolerable toxicity, initiation of new antitumor therapy, death, loss to follow-up, or other treatment-terminating conditions (whichever occurred first).
| Study group | Role | What they receive |
|---|---|---|
| Vebreltinib 150mg BID plus PLB1004 80mg QD | Experimental | Subjects will receive Vebreltinib 150mg orally twice per day (BID) plus 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 |
| Pemetrexed plus cisplatin/carboplatin | Active comparator | Subjects randomized to the control group will receive pemetrexed 500 mg/m² + platinum-based chemotherapy (carboplatin AUC 5 or cisplatin 75 mg/m²) via intravenous infusion for 4-6 cycles (determined by the investigator) as initial therapy, followed by pemetrexed maintenance therapy (500 mg/m²) until disease progression, intolerable toxicity, initiation of new antitumor therapy, death, loss to follow-up, or other treatment-terminating conditions (whichever occurred first) Receives: Drug: Pemetrexed plus Carboplatin or Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) by BICR
Progression-free survival (PFS) as assessed by a Blind Independent Center Review Committee (BICR) with reference to RECIST v1.1 for Solid tumors.
Measured: 2 years
Secondary outcomes (13)
Progression-Free Survival (PFS) by the investigator
Refer to RECIST v1.1, PFS assessed by the investigator.
Measured: 2 years
The objective response rate of the tumor (ORR)
Refer to RECIST v1.1, ORR assessed by the investigator and BICR.
Measured: 2 years
Duration of Response (DoR)
Refer to RECIST v1.1, DoR assessed by the investigator and BICR.
Measured: 2 years
The disease control rate (DCR)
Refer to RECIST v1.1, DCR assessed by the investigator and BICR.
Measured: 2 years
Overall Survival (OS)
OS is defined as the time from the date of the first dose until the date of death due to any cause.
Measured: 3 years
Objective Response Rate (ORR) in subjects with baseline intracranial metastases
Refer to RECIST v1.1，ORR assessed by the investigator and BICR.
Measured: 2 years
The Disease Control Rate (DCR) in subjects with baseline intracranial metastases
Refer to RECIST v1.1, DCR assessed by the investigator and BICR.
Measured: 2 years
Duration of Response (DoR) in subjects with baseline intracranial metastases
Refer to RECIST v1.1, DoR assessed by the investigator and BICR.
Measured: 2 years
Progression-Free Survival (PFS) in subjects with baseline intracranial metastases
Refer to RECIST v1.1, PFS assessed by the investigator and BICR.
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
Plasma concentrations of Vebreltinib and PLB1004
Plasma concentrations of Vebreltinib and PLB1004.
Measured: 2 years
Second progression-free survival (PFS2)
Investigator-assessed second progression-free survival (PFS2).
Measured: 2 years
Assess the Quality of Healthy Living About Patients（EQ-5D-5L）
Use the EQ-5D-5L scale to measure patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 5 levels: 1= no difficulty, 2= slight difficulty, 3= moderate difficulty, 4= serious difficulty, 5= extremely serious difficulty. The higher the score has the worse the health.
Then, the score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy.
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 posted14 May 2025
- Study start15 May 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 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
- NCT06970782
- Sponsor's protocol ID
- PLB1001/PLB1004-NSCLC-III-01
- Acronym
- KYLIN-3
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Randomized, Controlled, Open Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure
- ClinicalTrials.gov ID
- NCT06970782
- Acronym / sponsor ID
- KYLIN-3 / PLB1001/PLB1004-NSCLC-III-01
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- NSCLC, Lung Cancer, MET Amplification, EGFR L858R, EGFR Exon 19 Deletion, EGFR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Avistone Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 May 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.
Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure
Detailed description
A Randomized, Controlled, Open Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure
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 plus PLB1004 80mg QD | Experimental | Drug: Vebreltinib, Drug: PLB1004Subjects will receive Vebreltinib 150mg orally twice per day (BID) plus PLB1004 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. |
| Pemetrexed plus cisplatin/carboplatin | Active comparator | Drug: Pemetrexed plus Carboplatin or CisplatinSubjects randomized to the control group will receive pemetrexed 500 mg/m² + platinum-based chemotherapy (carboplatin AUC 5 or cisplatin 75 mg/m²) via intravenous infusion for 4-6 cycles (determined by the investigator) as initial therapy, followed by pemetrexed maintenance therapy (500 mg/m²) until disease progression, intolerable toxicity, initiation of new antitumor therapy, death, loss to follow-up, or other treatment-terminating conditions (whichever occurred first) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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).
- At least one measurable lesion as defined by RECIST V1.1.
- ECOG performance status 0 to 1.
Key exclusion criteria (5 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.
- Before randomization, patients did not recover from any toxicity and/ or complications of previous chemotherapy, surgery, radiotherapy and other anti-cancer treatments, that is, did not fall to grade 1 or lower (National Cancer Research Common Toxicity Criteria for Adverse Events [NCI-CTCAE] v5.0), except for hair loss and irrecoverable permanent radiation damage.
- Major surgery or had significant traumatic injury within 4 weeks prior to the first dose of the investigational product.
- 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 Enteric-coated Capsule orally twice per day (BID). | Drug | Vebreltinib 150mg BID plus PLB1004 80mg QD |
| PLB1004Also: AndamertinibSubjects will receive PLB1004 80mg orally once per day (QD). | Drug | Vebreltinib 150mg BID plus PLB1004 80mg QD |
| Pemetrexed plus Carboplatin or CisplatinSubjects randomized to the control group received pemetrexed 500 mg/m² + platinum-based chemotherapy (carboplatin AUC 5 or cisplatin 75 mg/m²) via intravenous infusion for 4-6 cycles (determined by the investigator) as initial therapy, followed by pemetrexed maintenance therapy (500 mg/m²) until disease progression, intolerable toxicity, initiation of new antitumor therapy, death, loss to follow-up, or other treatment-terminating conditions (whichever occurred first). | Drug | Pemetrexed plus cisplatin/carboplatin |
Primary outcome
Progression-Free Survival (PFS) by BICR
Time frame: 2 years
Progression-free survival (PFS) as assessed by a Blind Independent Center Review Committee (BICR) with reference to RECIST v1.1 for Solid tumors.
13 secondary outcomes
Progression-Free Survival (PFS) by the investigator
Time frame: 2 years
The objective response rate of the tumor (ORR)
Time frame: 2 years
Duration of Response (DoR)
Time frame: 2 years
The disease control rate (DCR)
Time frame: 2 years
Overall Survival (OS)
Time frame: 3 years
Objective Response Rate (ORR) in subjects with baseline intracranial metastases
Time frame: 2 years
The Disease Control Rate (DCR) in subjects with baseline intracranial metastases
Time frame: 2 years
Duration of Response (DoR) in subjects with baseline intracranial metastases
Time frame: 2 years
Progression-Free Survival (PFS) in subjects with baseline intracranial metastases
Time frame: 2 years
Incidence of Treatment-Emergent Adverse Events
Time frame: 2 years
Plasma concentrations of Vebreltinib and PLB1004
Time frame: 2 years
Second progression-free survival (PFS2)
Time frame: 2 years
Assess the Quality of Healthy Living About Patients（EQ-5D-5L）
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.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vebreltinib, PLB1004 and Pemetrexed plus Carboplatin or Cisplatin in people with Non-Small-Cell Lung Cancer, run by Avistone Biotechnology Co., Ltd..
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 5 inclusion and 5 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: opening soon, 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.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Progression-Free Survival (PFS) by BICR (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.