A Clinical Trial of Furmonertinib Combination Therapy As Neoadjuvant Treatment in Resectable EGFR-Mutated NSCLC
NCT Number: NCT06585644
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lung Cancer (NSCLC)
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2030-06-01

Summary:
Evaluate the efficacy and safety of neoadjuvant furmonertinib combined with anlotinib and chemotherapy in patients with resectable stage II-III EGFR mutation-positive non-small cell lung cancer.

Primary Outcome Measures: Objective Response Rate, According to RECIST 1.1, objective response rate (ORR) refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained that response for a specific duration, including those with complete response (CR) and partial response (PR). Complete response is defined as the complete disappearance of all target lesions, with the shortest diameter of any pathological lymph nodes (including both target and non-target nodes) shrinking to less than 10mm. Partial response is characterized by at least a 30% reduction in the diameter of the target lesion compared to baseline levels. In this study, ORR is defined as the proportion of patients who completed neoadjuvant therapy before surgery and achieved either CR or PR based on CT evaluation three weeks after treatment., 3 Weeks
Secondary Outcome Measures: Major Pathological Response, The Major Pathological Response (MPR) is defined as the proportion of patients, among all those who have completed treatment, with less than 10% residual primary tumor under microscopic examination with hematoxylin and eosin (HE) staining., 3 Weeks|Complete Pathological Response, Complete Pathological Response (CPR) is defined as the proportion of patients, among all those who have completed treatment, in whom there is no residual cancer in the primary tumor and lymph nodes under HE staining microscopy., 3 Weeks|R0 Resection Rate, The R0 resection rate is defined as the proportion of patients whose surgical margins are negative and there is no residual tissue visible under the microscope after the operation among all patients who have completed treatment., 3 Weeks|Disease Free Survival, The disease-free survival (DFS) refers to the time from curative surgery to the time when the patient experiences recurrence or death due to disease progression., 5 years|Overall Survival, The overall survival (OS) is defined as the time from randomization to the occurrence of death from any cause in participants., 5 years|Treatment-Related Adverse Events, Treatment-related adverse events refer to the number of adverse events related to the neoadjuvant treatment regimen assessed according to CTCAE V4.0., 3 Months|Health-Related Quality of Life, The health-related quality of life (HRQOL) was evaluated according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30 \&amp;amp; LC13, Version 3) for lung cancer patients., 5 years