Neoadjuvant Afatinib Therapy for Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma
Status:
Recruiting
Trial end date:
2026-12-30
Target enrollment:
Participant gender:
Summary
In general, for patients with stage I or II disease, surgery provides the best chance for
cure.EGFR tyrosine kinase inhibitors(TKIs)are standard first-line treatment for EGFR-mutant
advanced NSCLC.Afatinib was a 2nd-generation EGFR TKI that covalently bound and irreversibly
blocked signaling through activated EGFR, human epidermal growth factor receptor 2 (HER2),
and ErbB4 receptors, and the FDA has approved afatinib for first-line treatment of patients
with metastatic NSCLC who have sensitizing EGFR mutations.The treatment of stage III NSCLC
remains a matter of debate. Current multimodality treatment options for stage III included
definitive chemoradiation, surgery followed by adjuvant therapy,or neoadjuvant therapy
followed by surgical resection.Previous studies have revealed that adjuvant EGFR-TKI could
significantly prolong disease free surivival, and have less toxicity than adjuvant
chemotherapy for early resectable EGFR mutation positive NSCLC patients.EMERGING-CTONG1103
regarding neoadjuvant erlotinib vs chemotherapy (Gemcitabine plus cisplatin) for stage III
NSCLC reveal that erlotinib has improved ORR (54%), major pathological response, operation
rate, R0 resection and lymph node downstaging, and progression-free survival (PFS).A phase II
trial (ASCENT) of neoadjuvant afatinib for stage III EGFR-mutation NSCLC concludes that
afatinib yields the highest ORR (75%) up to now and verifies the feasibility of neoadjuvant
EGFR TKIs for stage III NSCLC. However, no more studies are available so far to confirm the
efficacy and safety of neoadjuvant afatinib in the treatment of resectable stage III EGFR
mutation-positive NSCLC, and there is a lack of studies based on the Chinese population.
Given that the neoadjuvant therapy has delayed the operation time and there is a potential
risk of cancer progression, more data are needed to perform evaluation.