A Study of PLB1001 in Non-small Cell Lung Cancer With c-Met Dysregulation(KUNPENG)

NCT04258033 | Active Not Recruiting Phase 2

• 1 other identifier: PLB1001-II-NSCLC-01
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II, open-label, multicenter and multi-cohorts study of PLB1001 administered orally twice daily to locally advanced/metastatic NSCLC patients with c-Met dysregulation.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Objective response rate will be determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Objective response rate is defined as the percentage of patients who experienced either a complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

  2 years

Secondary Outcomes (7)

• Progression free survival

  2 years

• Overall survival

  4 years

• Disease control rate

  2 years

• Time to response

  2 years

• Duration of response

  2 years

Study Arms (1)

PLB1001

EXPERIMENTAL

Subjects will receive 200mg of PLB1001 twice daily in cycles of 28-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

Drug: PLB1001

Interventions

PLB1001 DRUG

PLB1001 is a capsule in the form of 25 mg and 100mg, twice daily.

Also known as: Bozitinib

PLB1001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Age≥18 years
• Histologically or cytologically confirmed advanced non-small cell lung cancer
• Must have evidence of c-Met dysregulation from the results of molecular pre-screening evaluations
• At least one measurable lesion as per RECIST v1.1
• Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1
• ECOG Performance Status of 0-1.

You may not qualify if:

• Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits.
• Clinically significant, uncontrolled heart diseases Unstable angina History of documented congestive heart failure (New York Heart Association functional classification \> II) Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 100 mm Hg Arrhythmias
• Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
• Major surgery within 4 weeks prior to starting PLB1001
• Previous anti-cancer and investigational agents within 2 weeks before first dose of PLB1001. If previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before first dose of PLB1001
• Pregnant or nursing women
• Involved in other clinical trials \< 2 weeks prior to Day. If previous treatment of clinical trial is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before first dose of PLB1001.

Sponsors & Collaborators

• Beijing Pearl Biotechnology Limited Liability Company: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Related Publications (3)

• Wu YL, Yao Y, Yang JJ, Wu L, Zhang W, Wang Y, Xu HP, Song Y, Zhang Y, Zhao J, Chen JH, Wang ZH, Wang QM, Hu J, Li XY, Fan Y, Chen Y, Fang J, Han D, Xue WZ, Liu SM, Zhou Q, Zhang PL, Shi HP. Vebreltinib in MET amplification-driven advanced non-small-cell lung cancer (KUNPENG): a single-arm, multi-cohort, multicentre, phase 2 study. Lancet Oncol. 2026 Jan;27(1):36-44. doi: 10.1016/S1470-2045(25)00594-7. Epub 2025 Dec 6.

  PMID: 41365311 DERIVED

• Yang JJ, Zhang Y, Wu L, Hu J, Wang ZH, Chen JH, Fan Y, Lin G, Wang QM, Yao Y, Zhao J, Chen Y, Fang J, Song Y, Zhang W, Cheng Y, Guo RH, Li XY, Shi HP, Xue WZ, Han D, Zhang PL, Wu YL. Vebreltinib for Advanced Non-Small Cell Lung Cancer Harboring c-Met Exon 14 Skipping Mutation: A Multicenter, Single-Arm, Phase II KUNPENG Study. J Clin Oncol. 2024 Nov;42(31):3680-3691. doi: 10.1200/JCO.23.02363. Epub 2024 Jul 26.

  PMID: 39058972 DERIVED

• Huang S, Li L, Yan N, Zhang H, Guo Q, Guo S, Geng D, Liu X, Li X. Case report: The effect of second-line vebreltinib treatment on a patient with advanced NSCLC harboring the MET exon 14 skipping mutation after tepotinib treatment. Front Oncol. 2024 Apr 19;14:1331387. doi: 10.3389/fonc.2024.1331387. eCollection 2024.

  PMID: 38706592 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yilong Wu, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 6, 2020
• Study Start: January 17, 2020
• Primary Completion: May 14, 2024
• Study Completion: December 31, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)