Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations

Stopped early · Phase 2

Conditions studied: EGFR Activating Mutation, Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer

In brief

This phase II trial studies how well targeted therapy works in treating patients with incurable non-small cell lung cancer with a genetic mutation. Giving drugs that target other genetic mutations or other specific proteins may work better when a patient has cancer caused by a driver mutation and the treatment that targets that mutation stops working.

Key facts

Study ID

NCT02949843

Run by

Wake Forest University Health Sciences

People needed

19

Starts

2017-03-10

Expected to finish

2021-01-12

Last updated by the study team

2024-06-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically or cytologically confirmed incurable non-small cell lung cancer that harbors an activating mutation in EGFR, MET, BRAF, V600E, RET, HER2, translocation in Alk, or translocation in ROS-1
• Patients must be receiving treatment or planning to start treatment with a tyrosine kinase inhibitor targeting the activated gene
• Patients may not be receiving the treatment targeting the activated gene as part of a clinical treatment trial other than the Precision Oncology Trial
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
• Total bilirubin =< 1.5 X institutional upper limit of normal
• Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine transaminase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

You may not qualify if…

• Emergent need for palliative radiation
• Patients may not be receiving any other investigational agents for the treatment of non-small cell lung cancer
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded; breastfeeding should be discontinued

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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