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

PHASE2CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

July 26, 2020

Primary Completion Date

February 28, 2022

Study Completion Date

August 30, 2022

Conditions
Lung Adenocarcinoma Stage IIIEGFR Gene Mutation
Interventions
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)"

Trial Locations (1)

200433

Shanghai Pulmonary Hospital, Shang'ai

All Listed Sponsors
lead

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

NCT04201756 - Neoadjuvant Afatinib Therapy for Potentially Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma | Biotech Hunter | Biotech Hunter