PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the efficacy and safety of PM8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer
The study is divided into two parts. The first part is single-arm study, 50 participants were enrolled as of 21 Nov 2023,and recruitment was completed. The second part is randomized, double-blind study, active controlled design , which will be integrated to another global III study (NCT06712355).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Beijing Cancer Hospital
Beijing, China
Jilin Cancer Hospital
Changchun, China
The First Affiliated Hospital of Chongqing Medical University
Objective response rate (ORR)
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Time frame: Up to approximately 2 years
Overall survival (OS)
OS is the time from the date of randomization or first dosing date to death due to any cause.
Time frame: Up to approximately 2 years
Progression free survival (PFS)
Progression free survival (PFS) is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).
Time frame: Up to approximately 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or stable disease (SD) based on RECIST v1.1.
Time frame: Up to approximately 2 years
Duration of response (DOR)
DOR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Time to response (TTR)
TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieve CR or PR (based on RECIST v1.1).
Time frame: Up to approximately 2 years
Pharmacokinetic (PK) parameters
The PK parameters including serum concentrations of PM8002 at different time points after study drug administration.
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Chongqing, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Anhui Provincial Hospital
Hefei, China
Central Hospital Affiliated To Shandong First Medical University
Jinan, China
Hebei Petro China Central Hospital
Langfang, China
Linyi Cancer Hospital
Linyi, China
...and 7 more locations
Time frame: Up to 30 days after last treatment
Anti-drug antibody (ADA)
To evaluate the incidence of ADA to PM8002.
Time frame: Up to 30 days after last treatment
Treatment related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Time frame: Up to 30 days after last treatment