Spots Global Cancer Trial Database for Neoadjuvant Immunotherapy in EGFR-mutant Localized NSCLC

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Trial Identification

Brief Title: Neoadjuvant Immunotherapy in EGFR-mutant Localized NSCLC

Official Title: Neoadjuvant Sintilimab Plus Chemotherapy in EGFR-mutant Stage II-IIIB NSCLC: A Single-arm, Open-label Prospective Study

Study ID: NCT05244213

Conditions

Non-small Cell Lung Cancer

EGFR Activating Mutation

Interventions

Sintilimab

Carboplatin

Nab paclitaxel

Study Description

Brief Summary: 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.

Detailed Description: 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.