NCT04201756

Neoadjuvant Afatinib Therapy for Potentially Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma

Neoadjuvant Afatinib Therapy for Potentially Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma: A Single-Arm, Open-Label, Phase II Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Adenocarcinoma Stage III
• EGFR Gene Mutation

Interventions

Type	Name	Description
DRUG	Afatinib	①Neoadjuvant treatment stage: the enrolled patients take afatinib at a dosage of 40mg per day, 8-16 weeks in total; and receive CT scan re-examination in the 4th/8th/12th post-therapy week. ②Surgical treatment stage: the patients who respond to alfatinib treatment (CR+PR) and the patients who do not respond to alfatinib therapy but could still undergo surgery (SD and PD) will receive radical lung lobectomy+systematic lymph node dissection. ③Adjuvant treatment stage: The CR, PR and SD patients who have been treated surgically will take alfatinib at a dosage of 40mg per day for at least 1 year. The SD and PD patients who could not receive operation and the PD patients who have received operation will be transferred into medical oncology or/and radiation oncology and receive comprehensive therapy (chemotherapy or/and radiotherapy, the regimen is designed by oncologist and radiologist)

Timeline

• Start date: 2020-07-26
• Primary completion: 2022-02-28
• Completion: 2022-08-30
• First posted: 2019-12-17
• Last updated: 2022-12-23

Locations

1 site across 1 country: China