NCT02132884

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

CancerCodeTM Informed, Molecularly Targeted Therapies in Non-small Cell Lung Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. The three month progression free survival (PFS) of patients treated with targeted agents in the second line setting based on the tumor molecular signature as defined by CancerCode will be 40% vs 20% with standard cytotoxic chemotherapy. SECONDARY OBJECTIVES: I. Response rate (RR). II. Overall survival (OS). III. Proportion of Arm-B patients whose second line therapy is changed as a result of physician access to CancerCode-50 results. IV. Concordance of variants identified when sequencing is performed on samples from the same patient collected at baseline and follow-up time points. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive standard of care therapy based on the discretion of the treating physician. ARM B: Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.

Conditions

• Malignant Pericardial Effusion
• Malignant Pleural Effusion
• Recurrent Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	cytology specimen collection procedure	Undergo collection of tissue and blood samples
PROCEDURE	therapeutic procedure	Receive standard of care treatment
DRUG	targeted therapy	Receive specific targeted therapy
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-05-07
• Last updated: 2019-09-04
• Results posted: 2018-01-16

Locations

1 site across 1 country: United States