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Afatinib With CT and RT for EGFR-Mutant NSCLC

Status: Recruiting
Phase: Phase 2
Diagnosis: Lung Cancer
NCT ID: NCT01553942 (View complete trial on
DFCI Protocol ID: 11-464


This research study is a Phase II clinical trial. Phase II clinical trials test the 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 and that study doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not yet approved the drug for the patients type of cancer or for any use outside of research studies. Chemotherapy and radiation is the standard treatment for the patients with stage III non-small cell lung cancer (NSCLC). For people with epidermal growth factor receptor (EGFR) mutations, adding a type of drug called a tyrosine kinase inhibitor (TKI) can help increase the response to treatment. Afatinib is a tyrosine kinase inhibitor. It has been studied in a previous research study in participants with more advanced NSCLC. Results from that study indicate it may be helpful in treating NSCLC with EGFR mutations. In this study, patients with stage III NSCLC and EGFR mutations will receive the standard treatment of radiation and chemotherapy. If possible, the patients tumor will be removed by surgery. Afatinib will be given before radiation and chemotherapy and after surgery. The aim of giving afatinib before radiation therapy is to try to shrink the tumor. This may make the radiation therapy more effective since radiation therapy tends to work better on smaller tumors. The goal of this study is to see if adding afatinib to standard treatment helps to improve the response to treatment.


Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute

Overall PI:
Lecia Sequist, MD, Massachusetts General Hospital

Site-responsible Investigators:
Geoffrey Oxnard, MD, Dana Farber Cancer Institute

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Bryan Marion,

Eligibility Criteria

Inclusion Criteria: - Histologically confirmed stage IIIA NSCLC - Measurable disease - Have lung cancer harboring an EGFR mutation - Must be evaluated by a medical oncologist, radiation oncologist and thoracic surgeon within 4 weeks of enrollment into study to document that they are a candidate for chemoradiation and for consideration of surgical resection (not required to be a surgical candidate) Exclusion Criteria: - Pregnant or breastfeeding - Prior EGFR TKI therapy - Prior treatment with radiation to the thoracic region (including breast irradiation) - Known pre-existing interstitial lung disease - Significant or recent gastrointestinal disorders with diarrhea as a major symptom - History or presence of relevant cardiovascular abnormalities - Any other concomitant serious illness or organ system dysfunction - Active hepatitis B, C or known HIV carrier - Known or suspected active drug or alcohol use - Known hypersensitivity to afatanib, cisplatin, or pemetrexed - Concomitant treatment with strong inhibitor of P-gp - History of an active malignancy within the last 3 years
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