Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC. (KYLIN-2)

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small-Cell Lung Cancer
• Intervention / Treatment: Drug: Vebreltinib; Drug: PLB1004; Drug: Osimertinib

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Liang Lin; Phone Number: 08-10-84148931; Email: linliang@avistonebio.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Jinji Yang, MD; Phone Number: +86-20-83827812; Email: yangjinji@gdph.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vebreltinib 150mg BID+PLB1004 80mg QD; 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.	Drug: Vebreltinib; Subjects will receive Vebreltinib orally twice per day (BID).; Other Names: Bozitinib; PLB1001; Drug: PLB1004; Subjects will receive PLB1004 80mg orally once per day (QD).; Other Names: Andamertinib
Active Comparator: Osimertinib 80mg QD; 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.	Drug: Osimertinib; Subjects will receive Osimertinib 80mg orally once per day (QD).; Other Names: AZD9291

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The disease control rate (DCR)	The incidence of complete response, partial response and stable disease.	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.	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).	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).	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.	2 Years

Collaborators and Investigators

• Sponsor: Avistone Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Yi long Wu, MD, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: August 25, 2024
• First Submitted That Met QC Criteria: August 25, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Lung Cancer; NSCLC; EGFR; EGFR L858R; MET Amplification; EGFR Exon 19 Deletion
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Osimertinib
• Other Study ID Numbers: PLB1001/PLB1004-NSCLC-II-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No