protocolSection identificationModule nctId: NCT06269211, orgStudyIdInfo id: RTS-019, briefTitle: Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer With EGFR Mutation and PD-L1 Positive Expression, acronym: TOPLINE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2030-01-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Ruijin Hospital, class: OTHER, collaborators name: Guangdong Provincial People's Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: Carcinoma, Non-Small-Cell Lung, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study has only one arm, neoadjuvant Toripalimab treatment arm. Primary endpoint is MPR. We apply the optimal design of Simon's two-stage model to calculate the sample size and set both sides α= 0.05 and power=0.8, resulting in a total sample size of 29. Among them, 10 patients will be enrolled in the first stage. If the number of MPR cases in the first stage is less than or equal to 1, the study will be terminated in the early stage; On the contrary, participants in the second stage will continue to be enrolled. If the total number of MPR cases is greater than or equal to 5 after the completion of the second stage, the study is considered positive., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 29, type: ESTIMATED, armsInterventionsModule interventions name: Toripalimab, outcomesModule primaryOutcomes measure: Major Pathological Response (MPR), secondaryOutcomes measure: Pathological Complete Response (pCR), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: 2-year Event Free Survival (EFS), secondaryOutcomes measure: 2-year Overall Survival (OS), secondaryOutcomes measure: Safety (Number of Participants With Grade 3 and Higher-grade Treatment-related Adverse Events), secondaryOutcomes measure: Feasibility (Number of Participants Who Finished Neoadjuvant therapy and Receive Surgery Within 3-6 Weeks After Neoadjuvant Therapies), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Provincial People's Hospital, city: Guangzhou, state: Guangdong, zip: 510180, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, city: Shanghai, state: Shanghai, zip: 200025, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False