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

A Phase II, Open-label, Multicenter and Multi-cohorts Study to Evaluate the Efficacy and Safety of PLB1001 in Advanced Non-small Cell Lung Cancer With c-Met Dysregulation

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: PLB1001

Detailed Description

PLB1001 will be administrated 200mg twice daily. The treatment will be discontinued for the patients who experience disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. A cycle of study treatment will be defined as 28 days of continuous dosing. The study includes 4 cohorts.

• Study Type: Interventional
• Enrollment (Estimated): 185
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Weizhe Xue, Ph. D; Phone Number: +86-10-84148931; Email: xueweizhe@pearlbio.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong General Hospital
      • Sub-Investigator: Jinji Yang, MD
      • Contact: Jinji Yang, MD; Phone Number: 50810 +86-20-83827812; Email: yangjinji@gdph.org.cn
      • Principal Investigator: Yilong Wu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PLB1001; 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; PLB1001 is a capsule in the form of 25 mg and 100mg, twice daily.; Other Names: Bozitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	Progression free survival is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD or death due to any cause. PD is defined as at least a 20 % increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.	2 years
Overall survival	Overall survival is defined as the time (in months) from first trial treatment administration to the date of death.	4 years
Disease control rate	Disease control rate according to RECIST 1.1 is the percentage of patients who experienced either a complete response (CR), partial response (PR) or stable disease (SD).	2 years
Time to response	Time to response according to RECIST 1.1 is the time from the first trial treatment administration to the CR/PR (whichever is first) criteria are first met. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% 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
Duration of response	Duration of response according to RECIST 1.1 is the time from when the CR/PR (whichever is first) criteria are first met until progression of disease (PD) or death due to any cause. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% 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
Occurrence of Treatment emergent adverse event (TEAEs)	This outcome measure will be presented as the percentage of subjects with any (serious) adverse event (AE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.	2 years
Maximum Plasma concentration (Cmax) of drug	In the study some Pharmacokinetics (PK) profiles of PLB1001 will be obtained following administration of PLB-1001 at pre-dose and at the 0.5, 2, 4, 6,10 hours time points on Cycle 1, Day 1 and on Cycle 1, Day 15.	Cycle 1, Day 1 and on Cycle 1, Day 15

Collaborators and Investigators

• Sponsor: Beijing Pearl Biotechnology Limited Liability Company
• Investigators: Principal Investigator: Yilong Wu, MD, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: PLB1001-II-NSCLC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No