drugset / Trial / NCT04470076

Neoadjuvant Afatinib Combination With Chemotherapy for Stage Ⅱa-Ⅲb NSCLC With EGFR Activating Mutation

NCT04470076

NaSingle-groupOpen-labelTreatment

Summary

The recommended adjuvant therapy for stage Ⅱa-Ⅲb Non-small cell lung cancer (NSCLC) were perioperative chemotherapy. The adjuvant or neoadjuvant chemotherapy for early stage lung cancer improved about 5% 5-year survival. As for advanced NSCLC with epidermal growth factor receptor (EGFR) activating mutation, epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) combination with chemotherapy had improved progression-free survival (PFS) compared with EGFR-TKI alone. We propose this trial of Neoadjuvant Afatinib Combination With Chemotherapy for Stage Ⅱa-Ⅲb NSCLC With EGFR Activating Mutation, which would maximize benefit early in a patient's treatment course. At the same time, dynamic 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography (18F-FDG PET) was used to evaluate the standardized uptake value (SUV) and uptake rate constant (Ki) changes of lesions before and after treatment, so as to accurately and quantitatively monitor the tumor response of different therapy.

Timeline

Start
2020-07-10
Primary completion
2021-12-30
Completion
2023-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 30 mg
Subject Carboplatin Small molecule 5 unknown
Subject Cisplatin Other / unclassified 75 mg/m2
Subject Gemcitabine Small molecule 1250 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous