Trial Summary
What is the purpose of this trial?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.
Is Comprehensive Genomic Analysis a promising treatment for advanced lung cancer?Yes, Comprehensive Genomic Analysis is promising for advanced lung cancer because it helps identify specific genetic changes in cancer cells. This can lead to more effective, personalized treatments, especially when standard tests don't find any targets. It can also help find treatment options for patients with a minimal smoking history, who might have unique genetic changes.14578
What safety data is available for genomic analysis in lung cancer treatment?The provided research does not directly address safety data for genomic analysis treatments like NGS or CGP in lung cancer. The studies focus on the diagnostic and therapeutic potential of these technologies, their role in identifying targetable mutations, and their application in clinical practice. However, they do not specifically discuss safety outcomes or adverse effects related to these genomic profiling methods.24567
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.
What data supports the idea that Genomic Analysis for Advanced Lung Cancer is an effective treatment?The available research shows that Genomic Analysis for Advanced Lung Cancer helps identify specific changes in the cancer's DNA that can be targeted with specific treatments. This is especially useful when standard tests do not find any targets. By using this method, doctors can find new treatment options for patients, which can lead to better outcomes. For example, one study found that it helps follow guidelines for testing certain genes in lung cancer, which can guide doctors to choose the best treatment for each patient. This approach can also help find patients who might benefit from new treatments being tested in clinical trials.12379
Eligibility Criteria
This trial is for adults with stage IV or recurrent non-small cell lung cancer who have a life expectancy of at least 3 months and are in relatively good health. They must not have had recent serious heart issues, active hepatitis, HIV, or other cancers that could affect the outcome. Pregnant women are excluded.Inclusion Criteria
I have a recent biopsy (not from a radiated site) that hasn't been followed by systemic therapy.
I can take care of myself and am up and about more than 50% of my waking hours.
I have stage IV or recurrent NSCLC and can provide tissue for genomic analysis.
My kidney function, measured by creatinine levels, is within the normal range.
Exclusion Criteria
I do not have serious illnesses like uncontrolled heart issues, recent heart attack, chronic hepatitis, HIV, or active infections.
Treatment Details
The study involves collecting tissue samples from patients to perform comprehensive genomic analysis. This may help identify specific DNA mutations in the cancer cells and allow doctors to customize treatments targeting these mutations.
1Treatment groups
Experimental Treatment
Group I: Ancillary-Correlative (comprehensive genomic analysis)Experimental Treatment2 Interventions
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.
Comprehensive Genomic Analysis is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Comprehensive Genomic Profiling for:
- Identification of specific gene mutations in non-small cell lung cancer
🇺🇸 Approved in United States as Comprehensive Genomic Profiling for:
- Identification of specific gene mutations in non-small cell lung cancer
🇨🇦 Approved in Canada as Comprehensive Genomic Profiling for:
- Identification of specific gene mutations in non-small cell lung cancer
🇯🇵 Approved in Japan as Comprehensive Genomic Profiling for:
- Identification of specific gene mutations in non-small cell lung cancer
Find a clinic near you
Research locations nearbySelect from list below to view details:
KCI at McLaren Greater Lansing, Mid Michigan PhysiciansLansing, MI
KCI at Northern MichiganPetoskey, MI
Barbara Ann Karmanos Cancer InstituteDetroit, MI
KCI at Northern Michigan PetoskeyPetoskey, MI
More Trial Locations
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Who is running the clinical trial?
Barbara Ann Karmanos Cancer InstituteLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Genomic profiling of lung adenocarcinoma patients reveals therapeutic targets and confers clinical benefit when standard molecular testing is negative. [2022]Identification of clinically relevant oncogenic drivers in advanced cancer is critical in selecting appropriate targeted therapy. Using next-generation sequencing (NGS)-based clinical cancer gene assay, we performed comprehensive genomic profiling (CGP) of advanced cases of lung adenocarcinoma.
Comprehensive Genomic Profiling Facilitates Implementation of the National Comprehensive Cancer Network Guidelines for Lung Cancer Biomarker Testing and Identifies Patients Who May Benefit From Enrollment in Mechanism-Driven Clinical Trials. [2019]The National Comprehensive Cancer Network (NCCN) guidelines for patients with metastatic non-small cell lung cancer (NSCLC) recommend testing for EGFR, BRAF, ERBB2, and MET mutations; ALK, ROS1, and RET rearrangements; and MET amplification. We investigated the feasibility and utility of comprehensive genomic profiling (CGP), a hybrid capture-based next-generation sequencing (NGS) test, in clinical practice.
Effect of a Collaboration Between a Health Plan, Oncology Practice, and Comprehensive Genomic Profiling Company from the Payer Perspective. [2023]Comprehensive genomic profiling (CGP) is a next-generation sequencing-based methodology that detects 4 classes of genomic alterations, as well as gene signature biomarkers such as microsatellite instability and tumor mutational burden. In the context of precision oncology, CGP can help to direct treatment to genomically matched therapies.
Expediting Comprehensive Molecular Analysis to Optimize Initial Treatment of Lung Cancer Patients With Minimal Smoking History. [2020]Lung cancer patients with tumors harboring actionable alterations can achieve very durable responses to first-line targeted therapy. However, identifying targetable alterations using next-generation sequencing (NGS) is a complex and time-intensive process. As actionable genetic alterations are enriched in lung cancers arising in patients with limited smoking history, we designed a workflow to expedite NGS testing for this group.
Co-occurring genetic alterations and primary EGFR T790M mutations detected by NGS in pre-TKI-treated NSCLCs. [2020]Next-generation sequencing (NGS)-based assays to understand various mutations and co-occurrence of genomic alterations in non-small cell lung cancer (NSCLC) have enabled understanding of treatment impact on clinical outcomes.
Next-generation sequencing informs diagnosis and identifies unexpected therapeutic targets in lung squamous cell carcinomas. [2021]Potentially targetable genomic alterations have been identified in lung squamous cell carcinoma (LUSC), but none have yet translated into effective therapy. We examined potential benefits of next generation sequencing (NGS) in a cohort of consecutive LUSC patients with emphasis on distinctions between smokers and light/never smokers and implications for clinical trial enrollment.
Clinical application of comprehensive genomic profiling panel to thoracic malignancies: A single-center retrospective study. [2023]The usefulness of comprehensive genomic profiling (CGP) panels for thoracic malignancies after completion of the standard treatment is unclear.
Accuracy of next-generation sequencing for molecular profiling of small specimen of lung cancer: a prospective pilot study of side-by-side comparison. [2022]Successful practice of precision medicine in advanced lung cancers relies on therapeutic regimens tailored to individual molecular characteristics. The aim of this study was to investigate the accuracy of small specimens for molecular profiling using next-generation sequencing (NGS).
First-Line Genomic Profiling in Previously Untreated Advanced Solid Tumors for Identification of Targeted Therapy Opportunities. [2023]Precision oncology using comprehensive genomic profiling (CGP) by next-generation sequencing is aimed at companion diagnosis and genomic profiling. The clinical utility of CGP before the standard of care (SOC) is still not resolved, and more evidence is needed.