This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely resected stage IA2-IB non-squamous NSCLC with high-risk factors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
This is a prospective, open, single-center, single-arm phase II clinical study with no driver mutations identified in the central laboratory,to evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely resected stage IA2-IB non-squamous NSCLC with high-risk factors.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITING3-year DFS rate
DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment. 3-year DFS rate is Disease-Free Survival at 3 Years.
Time frame: From date of randomisation up to approximately 5 years
DFS
DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment.
Time frame: From date of randomisation up to approximately 10 years
3-year OS rate
Defined as the percentage of patients alive at 3 years, respectively, estimated from a Kaplan Meier plot of OS at the time of the primary analysis
Time frame: From date of randomization up to approximately 5 years
5-year OS rate
Defined as the percentage of patients alive at 5 years, respectively, estimated from a Kaplan Meier plot of OS at the time of the primary analysis
Time frame: From date of randomization up to approximately 5 years
OS
OS is defined as the time from the date of randomisation until death due to any cause.
Time frame: From date of randomization up to approximately 10 years
Safety and tolerability in overall population
AEs graded by CTCAE version 5.0
Time frame: From date of randomisation up to approximately 10 years
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