Clinical trial NCT02178163: Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer
Official title: A Study to Assess the Ability to Initiate Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Based on Genomic Analyses of Tumor Specimens.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-06-30
Enrollment: 1020
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will assess the percentage of advanced NSCLC patients whose tumor samples can undergo genomic analysis and in whom therapy can begin based on the results of this analysis.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients receiving therapy based on genomic analyses among all eligible patients
timeFrame: Up to 21 days
Secondary outcomes:
measure: Overall response rate assessed according to Response Evaluation Criteria in Solid Tumors 1.1
timeFrame: Up to 2 years
measure: Progression free survival (PFS)
timeFrame: Time from the date of start of therapy based on genomic analysis until the date that progressive disease or death whichever is first reported, assessed up to 2 years
measure: Overall survival (OS)
timeFrame: From date of registration to up to 2 years
Other outcomes:
Locations:
city: Bay City
country: United States
facility: KCI at McLaren Bay Region
state: Michigan
city: Bloomfield Hills
country: United States
facility: KCI at Mclaren Bloomfield Hills
state: Michigan
city: Clarkston
country: United States
facility: KCI At McLaren Clarkston
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Flint
country: United States
facility: KCI at McLaren Flint
state: Michigan
city: Lansing
country: United States
facility: KCI at McLaren Greater Lansing, Mid Michigan Physicians
state: Michigan
city: Lapeer
country: United States
facility: KCI at McLaren Lapeer Region
state: Michigan
city: Mount Clemens
country: United States
facility: KCI at McLaren Macomb
state: Michigan
city: Mount Pleasant
country: United States
facility: KCI at McLaren Central Michigan
state: Michigan
city: Petoskey
country: United States
facility: KCI at Northern Michigan
state: Michigan
city: Port Huron
country: United States
facility: KCI at McLaren Port Huron
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Gerold Bepler, M.D.
role: PRINCIPAL_INVESTIGATOR
References: