This is a multicenter, prospective, open-label Phase II study designed to evaluate the safety and efficacy of adjuvant sintilimab therapy guided by minimal residual disease (MRD) in patients with Stage II-IIIB non-small cell lung cancer (NSCLC) who have not achieved a pathological complete response (non-pCR) after neoadjuvant immunotherapy combined with chemotherapy. The study is being conducted at the Third People's Hospital of Chengdu and the Guangdong Provincial People's Hospital.
Patients with Stage II-IIIB NSCLC who have not achieved a pathological complete response after neoadjuvant immunotherapy combined with chemotherapy will be enrolled in this study. Eligible patients will receive adjuvant sintilimab therapy guided by MRD. Patients should undergo a test 3 to 7 days after surgery, and another test 28 days (±3 days) after. surgery The results of these two tests will be used to determine the subsequent treatment pathway. Participants with two consecutive positive MRD test results or a single positive MRD test result will be included in the MRD + treatment cycle: they will receive adjuvant therapy with sintilimab (200 mg, intravenous infusion, every 3 weeks). Follow-up will be conducted every 3 months, during which chest CT scans and MRD tests will be performed. If the MRD test result turns negative, treatment will be discontinued and participants will be monitored. If the MRD test result remains positive, sintilimab treatment will continue. Participants with two consecutive negative MRD test results will be included in the MRD - treatment cycle: they will only receive follow-up observation. Follow-up will be conducted every 3 months, during which chest CT scans and MRD tests will be performed. If the MRD test result turns positive, adjuvant therapy with sintilimab (200 mg, intravenous infusion, every 3 weeks) will be initiated. If the MRD test result remains negative, follow-up observation will continue. The maximum number of treatment cycles for sintilimab therapy is 18 cycles. Safety will be evaluated through adverse events (AE) and laboratory tests.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Patients who met the inclusion criteria were treated with adaptive adjuvant sintilimab therapy guided by MRD. Patients should test twice at postoperative days 3 to 7 and again at postoperative day 28 (±3 days). The results of these two tests will be used to determine the subsequent treatment pathway. Participants with two consecutive positive MRD tests or a single positive MRD test will be enrolled in the MRD+ treatment cycle：they will receive adjuvant treatment with sintilimab (200 mg, intravenous infusion, every 3 weeks). Follow-up visits will be conducted every 3 months, during which chest CT scans and MRD testing will be performed. If MRD becomes negative, treatment will be discontinued and the participant will be monitored. If MRD remains positive, treatment with sintilimab will continue. Participants with two consecutive negative MRD tests will be enrolled in the MRD- treatment cycle：they will undergo follow-up observation only. Follow-up visits will be conducted every 3 months
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGThe third people's hospital of chengdu
Chengdu, Sichuan, China
RECRUITING2-year EFS rate
Event-free survival (EFS) is defined as the time from the date of randomization (or the start of treatment) to the first occurrence of any of the following events: disease progression, local or distant recurrence, or death due to any cause. If a patient does not experience any of these events within 2 years, they are considered to have achieved 2-year EFS.
Time frame: 2 year after treatment initiation
mEFS
The median Event-Free Survival (mEFS) is defined as the median time from the date of randomization or the initiation of treatment to the first occurrence of a prespecified event, such as disease progression, death, or change in treatment regimen.
Time frame: From enrollment to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
2-year OS rate
The 2-year Overall Survival (OS) rate is defined as the proportion of patients who remain alive at the specific time point of 2 years from the date of randomization or the initiation of treatment.
Time frame: 24 months
mOS
The median overall survival (mOS) is defined as from date of enrollment until the date of first documented date of death from any cause, whichever came first, assessed up to 40 months, at which the survival rate is 50%.
Time frame: OS is defined as the time from enrollment to death, regardless of disease recurrence, assessed up to 100 months
AEs
Safety and tolerability will be assessed by the incidence of adverse events (AEs), serious adverse events (SAEs), immune-related adverse events (irAEs), deaths, and laboratory abnormalities.
Time frame: 24 months
QoL
Per physician's discretion, the patient will complete one or more of the following QoL instruments: EQ-5D is a 5 item questionnaire with a total score ranging from 0 to 100 with the higher score indicating greater satisfaction, EORTC QLQ-C30 is a 30 item questionnaire with a total score ranging from 1 to 4 with the lower score indicating greater satisfaction.
Time frame: 24 months
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