Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06574347

Acronym

KYLIN-2

Enrollment

120

Registered

2024-08-27

Start date

2024-08-07

Completion date

2027-07-31

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small-Cell Lung Cancer

Keywords

NSCLC, Lung Cancer, MET Amplification, EGFR L858R, EGFR Exon 19 Deletion, EGFR

Brief summary

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.

Interventions

DRUGVebreltinib

Subjects will receive Vebreltinib orally twice per day (BID).

DRUGOsimertinib

Subjects will receive Osimertinib 80mg orally once per day (QD).

DRUGPLB1004

Subjects will receive PLB1004 80mg orally once per day (QD).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Ability to understand and willingness to sign a written informed consent document. 2. Aged at least 18 years old. 3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\ IV). 4. Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) . 5. At least one measurable lesion as defined by RECIST V1.1. 6. ECOG performance status 0 to 1.

Exclusion criteria

1. There are mutations of ALK or ROS1. 2. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control. 3. Pregnant or nursing women.

Design outcomes

Primary

Measure	Time frame	Description
The objective response rate of the tumor (ORR)	2 Years	The incidence of confirmed complete response or partial response.

Secondary

Measure	Time frame	Description
The disease control rate (DCR)	2 Years	The incidence of complete response, partial response and stable disease.
Duration of Response (DoR)	2 Years	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.
Progression-free survival (PFS)	2 Years	Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Time to Response (TTR)	2 Years	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).
Incidence of Treatment-Emergent Adverse Events	2 Years	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.

Countries

China

Contacts

Primary ContactLiang Lin

linliang@avistonebio.com08-10-84148931

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026