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

Stage IV Non-small Cell Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02178163
• Other study ID #: 2014-002
• Secondary ID: NCI-2014-00913W8
• Status: Recruiting
• Phase: N/A
• Start date: June 2014
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: Gerold Bepler, M.D.
• Phone: (313) 576-8665
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1020
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Recurrent Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Intervention

Other:
• cytology specimen collection procedure
Correlative studies
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	KCI at McLaren Bay Region	Bay City	Michigan
United States	KCI at Mclaren Bloomfield Hills	Bloomfield Hills	Michigan
United States	KCI At McLaren Clarkston	Clarkston	Michigan
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	KCI at McLaren Flint	Flint	Michigan
United States	KCI at McLaren Lapeer Region	Lapeer	Michigan
United States	KCI at McLaren Macomb	Mount Clemens	Michigan
United States	KCI at McLaren Central Michigan	Mount Pleasant	Michigan
United States	KCI at Northern Michigan Petoskey	Petoskey	Michigan
United States	KCI at McLaren Port Huron	Port Huron	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients receiving therapy based on genomic analyses among all eligible patients	Will be estimated with 95% confidence interval (CI) using the Wilson's method.	Up to 21 days
Secondary	Overall response rate assessed according to Response Evaluation Criteria in Solid Tumors 1.1	Response rate will be estimated with 95% Wilson's CI.	Up to 2 years
Secondary	Progression free survival (PFS)	PFS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data.	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
Secondary	Overall survival (OS)	Not all patients enrolled on the study will receive therapy based on genomic analyses therefore survival will be analyzed for patients who receive therapy based on genomic analyses, for patients who don't receive therapy based on genomic analyses and for the entire patient population. OS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data.	From date of registration to up to 2 years