A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer

Status:	Completed
Conditions:	Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	7/19/2017
Start Date:	July 2013
End Date:	September 2015

Phase 2 Open Label Trial Of Oral Intermittent Dacomitinib In Patients With Advanced Nsclc

This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each
two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of
patients, those whose tumor has a documented T790M mutation, and those without this mutation.
All patients will receive repeated cycles of dacomitinib until disease progression,
occurrence of unacceptable toxicity, or other withdrawal criteria are met.

Inclusion Criteria:

- Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).

- Evidence of T790M mutation to enroll in Cohort A.

- Evidence of measurable disease by radiographic technique.

- Adequate organ function.

Exclusion Criteria:

- Patients with T790M mutation who stopped any prior EGFR-directed therapy without
evidence of disease progression.

- Symptomatic brain metastases.

- Uncontrolled or significant cardiovascular disease.

- Pregnant or breastfeeding.

We found this trial at

sites

Severance Hospital, Yonsei University Health System

Seoul, 12075

from

Seoul,