Genetic Sequencing-Informed Targeted Therapy in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized clinical trial studies how well genetic sequencing-informed targeted therapy works in treating patients with stage IIIB-IV non-small cell lung cancer. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of tumor cells that may have less harm to normal cells. Genetic sequencing may help identify these specific types of tumor cells in patients with non-small cell lung cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Patients with cytologically or histologically confirmed non-small cell lung cancer (NSCLC) - locally advanced, stage IIIB OR stage IV or stage IVM1A (malignant pleural or pericardial effusion or pleural implants) OR recurrence after primary surgery or radiotherapy (refer to 2010 American Joint Committee on Cancer [AJCC] staging, 7th edition [Ed])

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)-1.1 criteria; previous irradiated tumor is acceptable if there is at least a 20% increase in the size of the previously irradiated lesion

• Patients must be suitable candidates for treatment with standard regimens; this includes having adequate hematologic parameters, liver function and renal function based on labs that are deemed acceptable for treatment by the investigators

• Previous radiation allowed provided that 2 weeks has passed since radiation and/or the patient has recovered from the side effects

• Availability of archival diagnostic tissue (paraffin tissue block, cytospin block from a fine needle aspirate, or unstained slides from resected tumor, core biopsy, or fine needle aspirate) is required

• Able and willing to sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

• Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use effective methods of contraception during active treatment and for the duration of the study

Exclusion Criteria:

• Prior treatment with any investigational or targeted therapies

• Patients with known activating mutations in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma receptor tyrosine kinase (ALK) or c-ros oncogene 1, receptor tyrosine kinase (ROS-1) (this test [ROS-1] will be done only on select patients and at the discretion of treating physicians) translocation positive; the mutational status of all patients will be determined prior to study entry

• Prior malignancy within the past 3 years other than complete resection of basal or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate cancer after curative therapy

• Prior systemic therapy within 14 days of initiating protocol treatment

• Symptomatic brain metastasis or asymptomatic brain metastasis that are 1 cm or greater in size; patients with asymptomatic sub-centimeter brain metastasis are eligible

• Uncontrolled or unstable medical or psychiatric co-morbidities which would clearly limits patients participation

• Current, recent (within 2 weeks of enrollment of this study), or planned participation in an experimental drug study

• Unstable angina

• Pregnant (positive serum pregnancy test) or breast feeding

• History of any disease that could lead to impaired absorption of drugs

• Inability to comply with study and/or follow-up procedures

• Prior allogeneic bone marrow or organ