To evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of Almonertinib combined with SHR-1701 in relapsed or advanced NSCLC To evaluate the efficacy of Almonertinib combined with SHR-1701 in the first-line treatment of relapsed or advanced NSCLC
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Phase Ⅰb/Phase Ⅱ: SHR-1701: injection, intravenous infusion Almonertinib: tablets, oral
Phase Ⅱ: Almonertinib: tablets, oral
Dose limiting toxicity (Phase Ib)
Time frame: 21 days after the first dose
The incidence and severity of ≥ grade 3 treatment-related adverse events (TRAE) and serious adverse events (TRSAE) in the combination of two drugs (Phase Ib)
Time frame: from the time when all informed subjects signed the informed consent to the end of the safety follow-up period
PFS rate at 12 months
Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame: 12 months after the first medication for the last subject
Adverse Events and Serious Adverse Events
Time frame: up to 3 years
Proportion of dose pauses, dose downgrades and dose terminations due to study-drug related toxicities during the trial
Time frame: up to 3 years
ORR
Time frame: up to 3 years
DCR
Disease Control Rate, determined using RECIST v1.1 criteria
Time frame: up to 3 years
DoR
Duration of Response, determined using RECIST v1.1 criteria
Time frame: up to 3 years
DepOR
Depth of tumor remission, determined using RECIST v1.1 criteria
Time frame: up to 3 years
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PFS
Progression-Free-Survival, determined using RECIST v1.1 criteria
Time frame: up to 3 years
OS
OS is the time interval from the date of randomization to death due to any reason or lost of follow-up
Time frame: up to 5 years