Genetic Sequencing-Informed Targeted Therapy in Treating Patients With Stage IIIB-IV Non-small Ce… (NCT02132884) | Clinical Trial Compass
TerminatedNot Applicable
Genetic Sequencing-Informed Targeted Therapy in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer
Stopped: Feasibility
United States1 participantsStarted 2015-03
Plain-language 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.
Who can participate
SexALL
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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 …
What they're measuring
1
Progression Free Survival
Timeframe: Time from start of second line treatment to time of progression or death, whichever occurs first, assessed at 3 months