This is an open-label phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of JS004 injection combined with toripalimab and with or without standard chemotherapy in patients with advanced lung cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
119
200mg via IV infusion once every 3 weeks;JS004 will be administered in combination with toripalimab until disease progression or intolerable toxicity or up to 2 years of treatment or other reasons specified in the protocol
240mg via IV infusion once every 3 weeks;JS004 will be administered in combination with toripalimab until disease progression or intolerable toxicity or up to 2 years of treatment or other reasons specified in the protocol
60 or 75mg/m2 via IV infusion on Day 1 of a 21-day cycle, which may be maintained until disease progression
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Incidence of adverse events (AEs)
Incidence of adverse events (AEs)
Time frame: 2 years
Incidence of SAEs
Incidence of serious adverse events (SAEs)
Time frame: 2 years
Incidence of irAEs
Incidence of immune-related adverse events (irAEs)
Time frame: 2 years
ORR
Efficacy endpoint: objective response rate (ORR) based on RECIST v1.1 criteria
Time frame: 2 years
DOR
Efficacy endpoints: duration of response
Time frame: 2 years
DCR
Efficacy endpoints: disease control rate
Time frame: 2 years
time to response (TTR)
Efficacy endpoints: time to response
Time frame: 2 years
PFS
Efficacy endpoints: progression-free survival
Time frame: 2 years
OS
Efficacy endpoints: overall survival (OS)
Time frame: 2 years
1-year OS rate
Efficacy endpoints: 1-Year overall survival (OS) rate
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500mg/m2 via IV infusion on Day 1 of a 21-day cycle for 4 cycles; Subjects who have disease progression after 4 cycles may continue to receive maintenance treatment with pemetrexed
75mg/m2 via IV infusion on Day 1 of a 21-day cycle for 4 cycles
AUC 5 via IV infusion on Day 1 of a 21-day cycle for 4 cycles
175mg/m2 via IV infusion on Day 1 of a 21-day cycle for 4 cycles
100mg/m2 via IV infusion on Days 1, 2, and 3 of a 21-day cycle for 4 cycles
Time frame: 1 year
Drug concentration in plasma
drug concentration at different time points after administration in an individual subject
Time frame: 2 years
incidence of ADA
incidence of anti-drug antibodies (ADA)
Time frame: 2 years
titer of ADA
titer of anti-drug antibodies (ADA)
Time frame: 2 years
incidence of Nab
incidence of neutralizing antibodies (Nab)
Time frame: 2 years
titer of Nab
titer of neutralizing antibodies (Nab)
Time frame: 2 years