PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II study to evaluate the efficacy and safety of PM8002 in combination with pemetrexed and carboplatin in patients with EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have failed to EGFR-TKI treatment.
This study is a phase II, single-arm study, 64 participants were enrolled as of 6 Feb 2024, and recruitment was completed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Medical Ethics Committee of Guangdong Provincial People's Hospital
Guangzhou, Guangdonng, China
Objective response rate (ORR)
Objective response rate 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
Progression free survival (PFS)
Progression free survival 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
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
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 include serum concentrations of PM8002 at different timepoints after study drug administration.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Correlation between PD-L1 expression and antitumor effect
To evaluate correlation between PD-L1 expression and antitumor effect
Time frame: Up to approximately 2 years