Phase II, single-arm, open-label single center study that assess clinical feasibility and safety of 3 cycles neoadjuvant Sintilimab plus chemotherapy in EGFR-mutant stage IIB-IIIB NSCLC (excluding N3) followed by optional adjuvant treatment upon investigators' decisions.
35 eligible patients will be enrolled and 3 cycles of Sintilimab 200mg + doublet platinum-based chemotherapy will be administered. Dynamic blood samples before, during or after neoadjuvant treatment will be obtained for exploratory analysis. Patients who showed inferior response to neoadjuvant treatment leading to unresectable disease will be scheduled for local radiation or other potential subsequent treatment regarding multidisciplinary discussion. After completion of local treatment (surgery or radiation), patients will be provided with optional adjuvant treatment including EGFR-TKI upon investigators' consideration. Patients will be followed with 5 years after surgery. The primary objective of the study is major pathological response (MPR) defined as no more than 10% residual tumor found in primary lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
200mg Q3W
AUC 5, d1 every 3 weeks
260 mg/m2, d1 every 3 weeks
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China
Major Pathological Response (MPR)
Percentage of Participants with Major Pathologic Response. MPR was defined as percentage of tumor cells within tumor bed less than 10% for primary lung lesions.
Time frame: MPR will be assessed within 2 weeks after surgery
Objective Response Rate (ORR)
ORR is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.
Time frame: Tumor response will be evaluated within 3-4 weeks after last dose of neoadjuvant treatment
Pathological Complete Response (pCR)
Evaluation of the pathological complete response: The pathological complete response is defined as the absence of residual tumor in both lung and lymph nodes after neoadjuvant treatment.
Time frame: pCR will be assessed within 2 weeks after surgery
Progression-free Survival (PFS)
The period after initiation of neoadjuvant treatment when no disease progression can be detected.
Time frame: From date of initiation of neoadjuvant treatment till the date of first documented disease progression or death, whichever came first, assessed up to 36 months.
Overall Survival (OS)
The period after initiation of neoadjuvant treatment when no all-cause death can be detected.
Time frame: From date of initiation of neoadjuvant treatment till the date of all-cause death, assessed up to 60 months.
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Adverse Events (AEs)
Incidence of all grade AE which has been confirmed to be correlated with neoadjuvant treatment
Time frame: From date of initiation of neoadjuvant treatment till treatment discontinuation, assessed up to 14 weeks.