Genomic Analysis for Advanced Lung Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen by Gerold Bepler, M.D., PhD.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Barbara Ann Karmanos Cancer Institute

Disqualifiers: Concurrent malignancy, Uncontrolled heart disease, HIV, others

No Placebo Group

Approved in 4 Jurisdictions

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Comprehensive Genomic Analysis for advanced lung cancer?

Comprehensive Genomic Profiling (CGP) helps identify specific genetic changes in lung cancer, which can guide doctors to choose targeted treatments that are more likely to work for each patient. Studies show that CGP can find treatment options when standard tests do not, and it aligns with guidelines for testing certain genetic markers in lung cancer. ^{1 2 3 4 5}

Is genomic analysis for lung cancer safe for humans?

The research articles focus on the benefits and applications of genomic analysis in lung cancer treatment, but they do not provide specific safety data for humans. ^{2 3 6 7 8}

How is Comprehensive Genomic Analysis different from other treatments for advanced lung cancer?

Comprehensive Genomic Analysis (CGA) is unique because it uses next-generation sequencing (NGS) to identify specific genetic changes in a patient's cancer, allowing for personalized treatment plans. This approach is particularly beneficial when standard molecular tests do not find actionable targets, offering a tailored therapy option based on the individual's unique cancer profile. ^{1 2 7 8 9}

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

Your absolute neutrophil count is higher than 1.5 x 10^9/L.

Laboratory tests should be done within 30 days of enrollment on the trial

I have a recent biopsy (not from a radiated site) that hasn't been followed by systemic therapy.

Exclusion Criteria

I have another cancer, but my doctor thinks it won't affect this treatment.

I am not pregnant or breastfeeding and willing to use birth control if I join the trial.

I do not have serious illnesses like uncontrolled heart issues, recent heart attack, chronic hepatitis, HIV, or active infections.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Genomic Analysis

Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, PCR, and microarray

Up to 21 days

Treatment

Patients may begin therapy based on the results of the genomic analysis

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months for 2 years, every 6 months for 3 years, and then every 12 months thereafter

Treatment Details

Interventions

• Comprehensive Genomic Analysis (Genomic Analysis)

Trial Overview 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.

Participant Groups

Group I: Ancillary-Correlative (comprehensive genomic analysis) Experimental Treatment 2 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 Nearby Select from list below to view details:

KCI at McLaren Greater Lansing, Mid Michigan Physicians Lansing, MI

KCI at Northern Michigan Petoskey, MI

Barbara Ann Karmanos Cancer Institute Detroit, MI

KCI at Northern Michigan Petoskey Petoskey, MI

More Trial Locations

Who Is Running the Clinical Trial?

Barbara Ann Karmanos Cancer Institute Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

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.

2. Singapore pubmed.ncbi.nlm.nih.gov

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.

3. England pubmed.ncbi.nlm.nih.gov

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.

4. United States pubmed.ncbi.nlm.nih.gov

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.

5. United States pubmed.ncbi.nlm.nih.gov

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.

6. Ireland pubmed.ncbi.nlm.nih.gov

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.

7. Germany pubmed.ncbi.nlm.nih.gov

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.

8. United States pubmed.ncbi.nlm.nih.gov

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.

9. England pubmed.ncbi.nlm.nih.gov

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).