Genomic Sequencing in Determining Treatment in Patients With Metastatic Cancer or Cancer That Cannot Be Removed by Surgery

Stopped early · Not applicable

Conditions studied: Metastatic Neoplasm, Recurrent Neoplasm, Recurrent Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer, Unresectable Malignant Neoplasm

In brief

This pilot clinical trial studies patients' genomic sequencing in determining specific treatments, also called Precision Medicine, in patients with cancer that has spread to other parts of the body (metastatic) and/or cannot be removed by surgery. Examining the genetic code of a patient's tumor, a mutation (a change in the deoxyribonucleic acid \[DNA\] sequence of a cell or gene) may be identified and matched with available treatment that targets the mutated gene or an alternative treatment that may provide benefit for the patient with the mutation identified. Precision medicine may impacts patient's response to treatment by targeting specific mutations and may increase survival and improve quality of life.

Key facts

Study ID

NCT02566421

Run by

Wake Forest University Health Sciences

People needed

110

Starts

2015-10-01

Expected to finish

2017-08-01

Last updated by the study team

2018-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with unresectable cancer for which there are genomic drivers with corresponding Food and Drug Administration (FDA) approved or experimental drugs available, e.g. non-small cell lung cancer; and/or patients with histologically confirmed metastatic malignancy that have failed standard treatment or cannot tolerate standard treatment as deemed by the treating physician
• Malignancy must be measureable as per appropriate guidelines
• Patients who are willing to provide a specimen for genomic sequencing
• Preferred method:
• Tumor cell sample available and of sufficient quantity in the Tumor Tissue Shared Resource or patients who are willing to undergo additional tissue collection for tumor genomic sequencing through FoundationOne; available specimens must have been harvested within two years to be eligible
• Alternative method:
• Patients who are unwilling or unable to provide a tumor tissue sample and who undergoes Guardant360 sequencing may be considered eligible by the treating physician
• Patients who have already had their specimens sent for genomic sequencing are eligible provided they have not received their sequencing results at the time of enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Absence of clinically relevant liver or kidney failure as deemed by the treating physician
• Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

You may not qualify if…

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diminished mental capacity or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnancy or lactation

Where it is running

• Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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