The study is a prospective, open label, multicenter, single arm Phase II clinical trial, aiming to explore the use of neoadjuvant Toripalimab for clinically stage II-IIIB NSCLC patients with EGFR mutations and PD-L1 positive expression, providing a novel perspective for further improving the prognosis of NSCLC patients. This study will provide valuable information for further clinical trials of neoadjuvant Toripalimab and other immune checkpoint inhibitors in NSCLC patients with EGFR mutations and PD-L1 positive expression.
For resectable locally advanced non-small cell lung cancer (NSCLC), the combination of neoadjuvant therapy and surgery has benefited the patients and has become a clinical routine and guideline recommended treatment. Among the East Asian NSCLC population, about 30% are positive for EGFR driver gene mutations. The efficacy of this population receiving neoadjuvant chemotherapy and EGFR inhibitors is limited, and their optimal neoadjuvant treatment strategy is still unclear. The neoadjuvant immunotherapy has achieved good therapeutic effects in driver-negative NSCLC patients, and is superior in PD-L1 expression positive patients. Based on the above evidence, the investigators plan to conduct a prospective, open label, multicenter, single arm Phase II clinical study to explore the use of neoadjuvant Toripalimab for clinically stage II-IIIB NSCLC patients with EGFR mutations and PD-L1 positive expression, providing a novel perspective for further improving the prognosis of NSCLC patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
240mg IV, Q3W
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGRuijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGMajor Pathological Response (MPR)
Defined as the incidence rate in postoperative pathology where the percentage of surviving tumor cells in the tumor bed is ≤ 10%, regardless of the presence or absence of live tumor cells in the lymph nodes.
Time frame: MPR will be assessed within 2 weeks after surgery
Pathological Complete Response (pCR)
Defined as the proportion of patients in postoperative pathology who have no residual live tumor cells in the primary tumor bed or in all excised lymph nodes.
Time frame: pCR will be assessed within 2 weeks after surgery
Objective Response Rate (ORR)
Based on the solid tumor evaluation criteria (RECIST 1.1), the sum of the proportions of complete and partial remission evaluated by imaging
Time frame: Tumor response will be evaluated within 30 days after last dose of neoadjuvant treatment
2-year Event Free Survival (EFS)
EFS is defined as the time from the first use of the investigational drug to any of the following events (whichever occurs first): the investigator assessed the disease progression based on imaging according to RECIST 1.1 and therefore was unable to receive curative surgery, local or distant recurrence, or death from any cause. A 2-year EFS is used as a secondary endpoint.
Time frame: 2 years after the date of initiation of neoadjuvant treatment
2-year Overall Survival (OS)
OS is defined as the date from the first use of the investigational drug until death from any cause. A 2-year OS is used as a secondary endpoint.
Time frame: 2 years after the date of initiation of neoadjuvant treatment
Safety (Number of Participants With Grade 3 and Higher-grade Treatment-related Adverse Events)
The safety evaluation will be based on weekly blood routine tests, liver and kidney function, electrolyte analysis, etc., and adverse reactions of level 3 or above will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0).
Time frame: From date of neoadjuvant treatment until surgery was applied during study period or up to at least 90 days after last dose.
Feasibility (Number of Participants Who Finished Neoadjuvant therapy and Receive Surgery Within 3-6 Weeks After Neoadjuvant Therapies)
Among patients who have been evaluated as operable after completing neoadjuvant therapy, a surgical period of no more than 42 days from the completion of neoadjuvant therapy is defined as feasible.
Time frame: 6 weeks after last dose of neoadjuvant treatment
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