Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation

Status: Recruiting
Phase: Phase 2
Diagnosis: Lung Cancer
NCT ID: NCT01746251 (View complete trial on
DFCI Protocol ID: 12-504


This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied. It also means that the FDA has not yet approved afatinib for use in patients. In this research study the investigators are looking to see if taking afatinib after surgery works better when taken over a short period of time, compared to a long period of time.


Conducting Institutions:
Massachusetts General Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Lecia Sequist, MD, Massachusetts General Hospital

Site-responsible Investigators:
Daniel Costa, MD, Beth Israel Deaconess Medical Center

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Pathologically confirmed diagnosis of non-small cell lung cancer with EGFR mutation - Complete surgical resection, pathologic stage IA-B, IIA-B, IIIA-B by AJCC 7th Edition staging criteria - Surgical resection with curative intent was at least 6 months prior to enrollment - At least 3 weeks have passed since completion of adjuvant chemotherapy or radiotherapy Exclusion Criteria: - Pregnant or breastfeeding - History of allergic reactions attributed to compounds of similar chemical composition to afatinib - Prior exposure to EGFR tyrosine kinase inhibitor - Evidence of clinically active interstitial lung disease - Radiographic evidence of recurrent NSCLC prior to afatinib treatment - Receipt of any experimental treatment within 30 days of start of treatment with afatinib until the end of treatment visit - Use of potent P-gp inhibitors and potent P-gp inducers must be avoided during treatment with afatinib - Individuals with a history of a different malignancy (except: synchronous or metachronous primary non-small cell lung cancers of lower stage than the cancer for which adjuvant treatment is currently being prescribed; disease free for at least 3 years; cervical cancer in situ; basal or squamous cell carcinoma of the skin) - HIV positive on combination antiretroviral therapy - Uncontrolled intercurrent illness
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