Clinical trial NCT04258033: A Study of PLB1001 in Non-small Cell Lung Cancer With c-Met Dysregulation(KUNPENG)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Beijing Pearl Biotechnology Limited Liability Company
Sponsor class: INDUSTRY
First posted: 2020-02-06
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate
timeFrame: 2 years
Secondary outcomes:
measure: Progression free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 4 years
measure: Disease control rate
timeFrame: 2 years
measure: Time to response
timeFrame: 2 years
measure: Duration of response
timeFrame: 2 years
measure: Occurrence of Treatment emergent adverse event (TEAEs)
timeFrame: 2 years
measure: Maximum Plasma concentration (Cmax) of drug
timeFrame: Cycle 1, Day 1 and on Cycle 1, Day 15
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Yilong Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: