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National Cancer Institute - U.S. National Institutes of Health - www.cancer.gov

Clinical Trial Spotlight
Lung Cancer – NCI-08-C-0086

Dr. Giuseppe Giaccone
Principal Investigator

NCI is currently conducting the following trial for patients with lung cancer. Click on the trial below for additional details, including a summary of eligibility criteria, treatment plan, and information on how to contact Dr. Giaccone and his staff directly.

You may also call the Clinical Trials Referral Office at 1-888-NCI-1937 (1-888-624-1937) to inquire about referring a patient to this trial.

A Phase II, Open-Label, Two Arm Trial to Evaluate the Efficacy of PF-00299804 in Patients With Advanced NSCLC After Failure of at Least One Prior Chemotherapy Regimen and Failure of Prior Treatment With Erlotinib
NCI-08-C-0086

  • All patients take 45 mg of PF-00299804 orally once daily for a cycle that is defined as 21 days
  • Pharmacokinetics will be collected in Cycle 1 and Cycle 2
  • 44 response-evaluable adenocarcinoma patients and 22 evaluable non-adenocarcinoma patients will be enrolled in the study
  • Blood for biomarkers will be drawn at baseline, at Cycle 2, and when the patient ends the study
  • Quality of life questionnaires will be done at baseline and prior to every cycle

Why is this trial important?

Currently, we are limited in the treatment options for patients with advanced non-small cell lung cancer (NSCLC). The use of standard chemotherapy using a platinum agent in addition to another approved cytotoxic chemotherapy agent has resulted in only small improvements in overall survival of patients with lung cancer. Recurrent and progressive disease after initial treatment has even fewer chemotherapy options. Erlotinib is currently the only oral agent approved in the United States for the treatment of advanced NSCLC. There is great need to further develop and examine new agents for the treatment of advanced NSCLC. PF-00299804 irreversibly binds to the Human Epidermal Growth Factor Receptor and may provide benefit after erlotinib has stopped working. This trial will determine the safety and efficacy of PF-00299804 in the treatment of recurrent or progressive NSCLC after failure of up to two chemotherapy regimens and erlotinib.

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