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Treatment Study for Patients with EGFR Mutation and ALK Positive Non-Small Cell Lung Cancer

Clinical Trial Title: 
Phase II multi-center study of pembrolizumab in combination with platinum-based doublet chemotherapy in patients with EGFR mutation and ALK positive non-small cell lung cancer with progressive disease following prior tyrosine kinase inhibitors (TKIs).
Clinical Trial Protocol ID: 
17101006
Clinical Trial Investigator Name: 
Mary Jo Fidler, MD
Clinical Trial Protocol Description: 

The main purpose of this study is to learn if the addition of pembrolizumab will enhance the efficacy of carboplatin and pemetrexed in EGFR (epidermal growth factor receptor) mutation and ALK (anaplastic lymphoma kinase) positive NSCLC (non-small cell lung cancer) patients who have disease progression following prior TKIs (tyrosine kinase inhibitors).

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are willing and able to provide written informed consent for the trial.
  • Have not received any systemic chemotherapy for advanced NSCLC. (Patients who have received neoadjuvant, adjuvant or as part of concurrent chemotherapy and radiation are eligible if they received the chemotherapy 12 months or more before the start of study therapy.)
  • Female subjects of childbearing potential: Have a negative urine or serum pregnancy within 1 week of enrollment.
  • Male subjects of child bearing potential: Agree to use an adequate method of contraception.

You will be excluded from the study if any of the following criteria apply to you:

  • Are currently participating and receiving study therapy or have participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. If the half-life of the drug is known then starting therapy 5 half-lives after the end of the last therapy is acceptable. Current or previous use of a prohibited medication, as listed in the study protocol.
  • Have hypersensitivity to pembrolizumab, carboplatin or pemetrexed or any of its excipients.
  • Have a known additional malignancy that is progressing or requires active treatment or the treating physician believes will require therapy within 1 year.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Lung and Chest Tumors
Contact Phone: 
(312) 563-3347
Contact Name: 
Deborah Pach, RN