Genomic analysis of tissue samples in patients with advanced lung cancer
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.
This study is testing whether analyzing tissue samples from patients with advanced lung cancer can help find specific gene changes that lead to better, personalized treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1020 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Barbara Ann Karmanos Cancer Institute Academic / other |
| Locations | 11 sites (Bay City, Michigan and 10 other locations) |
| Trial ID | NCT02178163 on ClinicalTrials.gov |
What this trial studies
This research focuses on conducting comprehensive genomic analysis on tissue samples from patients with recurrent or stage IV non-small cell lung cancer. The study aims to identify specific gene mutations that may guide personalized treatment options for these patients. Participants will undergo tissue sample collection and genomic analysis using advanced techniques such as mass spectrometry and PCR. Based on the genomic findings, eligible patients may initiate targeted therapy, and their progress will be monitored over several years.
Who should consider this trial
Good fit: Ideal candidates include patients with stage IV or recurrent non-small cell lung cancer who have available tissue samples for analysis or are willing to undergo a biopsy.
Not a fit: Patients whose tumors have already undergone genomic analysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective, personalized treatment strategies for patients with advanced lung cancer.
How similar studies have performed: Other studies have shown promise in using genomic analysis to tailor cancer treatments, indicating that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bay City, Michigan and 10 other locations
- KCI at McLaren Bay Region — Bay City, Michigan, United States (Recruiting)
- KCI at Mclaren Bloomfield Hills — Bloomfield Hills, Michigan, United States (Recruiting)
- KCI At McLaren Clarkston — Clarkston, Michigan, United States (Recruiting)
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- KCI at McLaren Flint — Flint, Michigan, United States (Recruiting)
- KCI at McLaren Greater Lansing, Mid Michigan Physicians — Lansing, Michigan, United States (Recruiting)
- KCI at McLaren Lapeer Region — Lapeer, Michigan, United States (Recruiting)
- KCI at McLaren Macomb — Mount Clemens, Michigan, United States (Recruiting)
- KCI at McLaren Central Michigan — Mount Pleasant, Michigan, United States (Recruiting)
- KCI at Northern Michigan — Petoskey, Michigan, United States (Recruiting)
- KCI at McLaren Port Huron — Port Huron, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Gerold Bepler, M.D. — Barbara Ann Karmanos Cancer Institute
- Study coordinator: Gerold Bepler, M.D.
- Phone: (313) 576-8665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.