Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer

Barbara Ann Karmanos Cancer Institute

Status: Enrolling

Conditions: Stage IV Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer

Treatments: Other: laboratory biomarker analysis; Other: cytology specimen collection procedure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02178163

P30CA022453 (U.S. NIH Grant/Contract)

2014-002

W81XWH-11-1-0500 (Other Identifier)

NCI-2014-00913 (Registry Identifier)

Details and patient eligibility

About

This research trial studies comprehensive genomic analysis in tissue samples from patients with non-small cell lung cancer that has come back or is stage IV. Comprehensive genomic analysis may identify specific gene mutations (changes in deoxyribonucleic acid [DNA]) and help doctors to tailor treatment to target the specific mutations.

Full description

PRIMARY OBJECTIVES:

I. To assess the percentage of advanced non-small cell lung cancer patients in whom therapy can be initiated based on genomic analysis of tumor specimens.

SECONDARY OBJECTIVES:

I. To estimate the percentage of patients in whom genomic analysis can be performed.

II. To assess the progression free survival and response rate in patients who start therapy based on the genomic analyses results.

OUTLINE:

Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, polymerase chain reaction (PCR), and microarray. Based on the results of the genomic analysis, patients may begin therapy.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months thereafter.

Enrollment: 1,020 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage IV or recurrent Non-Small Cell Lung Cancer patients who either have archival tissue for genomic analysis or are willing to undergo a new biopsy to obtain tumor tissue for genomic analysis. Patients whose tumor has already undergone genomic analysis will be eligible.
• Zubrod performance status 0-2
• Life expectancy >= 3 months
• Absolute neutrophil count of > 1.5 x 10^9/L
• Platelet count > 100,000 x 10^9/L
• Serum creatinine =< 1.5 times the institutional upper limit of normal (ULN) or calculated creatinine clearance (Cockcroft-Gault formula) of > 45 mL/min
• Serum bilirubin =< 1.5 X ULN
• Transaminases (serum glutamic oxaloacetic transaminase [SGOT] and/or serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times institutional ULN and alkaline phosphatase =< 2.5 times ULN, unless patient has liver metastases and the managing physician believes that the elevation in liver enzymes is only related to the liver metastases
• Laboratory tests should be done within 30 days of enrollment on the trial
• A biopsy of the patient's tumor for genomic profiling is required; this biopsy specimen can be an already obtained diagnostic specimen provided the patient has not received systemic therapy since the biopsy has been obtained and was obtained within 60 days of trial enrollment. The biopsy material cannot be from a tumor site that has been radiated.
• Signed informed consent that details the investigational nature of the study according to institutional and federal guidelines

Exclusion criteria

• Patients with concurrent malignancy; patients with prior or concurrent malignancy will be allowed as long as the treating physician considers it unlikely to impact the clinical outcome of the patient
• Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6 months of registration, history of chronic active hepatitis or history of human immunodeficiency virus (HIV) or an active bacterial infection will not be eligible
• Pregnant or lactating women; female patients of child bearing potential will be informed that if they do enroll on a therapeutic trial, based on the genomic analyses, that they may not be able to enroll on a clinical trial if they are pregnant; all sexually active patients will be informed that patients enrolling on a therapeutic trial have to use contraceptive methods to prevent pregnancy

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,020 participants in 1 patient group

Ancillary-Correlative (comprehensive genomic analysis)

Experimental group

Description:

Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, PCR, and microarray. Based on the results of the genomic analysis, patients may begin therapy.

Treatment:

Other: cytology specimen collection procedure

Other: laboratory biomarker analysis