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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
145
PLB1001 is a capsule in the form of 25 mg and 100mg, twice daily.
Guangdong General Hospital
Guangzhou, Guangdong, China
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.
Time frame: 2 years
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.
Time frame: 2 years
Overall survival
Overall survival is defined as the time (in months) from first trial treatment administration to the date of death.
Time frame: 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).
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Cycle 1, Day 1 and on Cycle 1, Day 15