AZD9291 First Time In Patients Ascending Dose Study

Status: Recruiting
Diagnosis: Lung Cancer
NCT ID: NCT01802632 (View complete trial on
DFCI Protocol ID: 13-344


This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Pasi Janne, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Lecia Sequist, MD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383,
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses - Aged at least 18 years. Patients from Japan aged at least 20 years. - Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC). - Previous treatment with a single-agent EGFR TKI (e.g. gefitinib or erlotinib). - Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing or evidence of non-child bearing potential. - Male patients should be willing to use barrier contraception. - For 1st Line expansion cohort ONLY, confirmation that the tumour is EGFRm+ve and have had no prior therapy for their advanced disease. Exclusion Criteria: - Treatment with an EGFR TKI (erlotinib or gefitinib) within 8 days (approximately 5x half-life) of the first dose of study treatment. - Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment. - AZD9291 in the present study (ie, dosing with AZD9291 previously initiated in this study). - Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection. - Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
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