Genomic Analysis for Advanced Lung Cancer

Recruiting at 11 trial locations

Overseen By Gerold Bepler, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Barbara Ann Karmanos Cancer Institute

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1020 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new method for analyzing the DNA of individuals with advanced non-small cell lung cancer through Comprehensive Genomic Analysis. By examining the genes in cancer tissue, doctors aim to identify specific changes that can guide personalized treatments. Patients with stage IV or recurrent non-small cell lung cancer who are willing to provide a tissue sample for analysis might be suitable candidates. This approach could help doctors select the best treatment based on individual genetic profiles. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to more personalized cancer treatments.

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 prior data suggests that comprehensive genomic analysis is safe for patients with advanced lung cancer?

Research has shown that comprehensive genomic analysis is a trusted method in cancer care. This test examines many genes simultaneously to help doctors identify specific DNA changes that may cause cancer to grow.

Studies have found that using this analysis to guide treatment is generally safe. It doesn't involve taking medicine or undergoing a procedure, so it carries few risks. The process involves collecting tissue samples, a common practice in cancer care and similar to other tests used to study cancer cells.

In summary, comprehensive genomic analysis helps customize treatment without adding significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comprehensive genomic analysis for advanced lung cancer because it offers a personalized approach to treatment. Unlike standard treatments such as chemotherapy or targeted therapies, this method involves analyzing the unique genetic makeup of a patient’s cancer through techniques like mass spectrometry and PCR. By understanding the specific genetic mutations driving an individual's cancer, doctors can tailor therapies that are more likely to be effective, potentially improving outcomes and reducing unnecessary side effects. This represents a shift from one-size-fits-all treatments to more precise, individualized care.

What evidence suggests that comprehensive genomic analysis is effective for advanced lung cancer?

Research has shown that analyzing the complete set of genes in cancer cells can greatly improve treatment for advanced non-small cell lung cancer (NSCLC). In this trial, participants will undergo comprehensive genomic analysis to identify specific gene changes in their cancer cells, helping doctors select the best treatments. This method has been linked to better patient outcomes and longer survival. Additionally, using a full genetic profile is more cost-effective than smaller tests and offers more treatment options. Understanding the cancer's genetic details allows for more precise and effective treatments. ^{2 4 6 7 8}

Who Is on the Research Team?

Gerold Bepler, M.D., PhD.

Principal Investigator

Barbara Ann Karmanos Cancer Institute

Are You a Good Fit for This Trial?

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.

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

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Barbara Ann Karmanos Cancer Institute

Lead Sponsor

Trials

166

Recruited

9,300+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Core needle biopsy (CNB) specimens can provide accurate molecular profiling for advanced lung cancers, showing an 83.9% concordance rate with surgical resection specimens in detecting genetic alterations.

Despite lower DNA yield and allele frequency in CNB specimens, the results for tumor mutational burden and microsatellite instability were comparable to those from resection specimens, indicating that CNB is a reliable method for guiding precision medicine in lung cancer treatment.

NCBI (Pubmed)

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. Ben, X., Tian, D., Zhuang, W., et al.[2022]

Next generation sequencing (NGS) of lung squamous cell carcinoma (LUSC) patients revealed that 38% of those tested had potentially targetable genomic alterations, which could qualify them for clinical trials or approved therapies.

The study found that light or never smokers had a higher rate of therapeutic targets (47%) compared to moderate or heavy smokers (35%), suggesting that NGS is particularly beneficial for this group in identifying treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next-generation sequencing informs diagnosis and identifies unexpected therapeutic targets in lung squamous cell carcinomas. Sands, JM., Nguyen, T., Shivdasani, P., et al.[2021]

In a 3-year study involving 96 patients at a community oncology practice, comprehensive genomic profiling (CGP) identified clinically relevant genomic alterations in 86 patients, with 15 receiving targeted therapies based on these results.

CGP detected significant alterations that conventional testing missed in 84% of a subset of patients, leading to treatment changes and facilitating clinical trial enrollment, which may have resulted in an estimated cost savings of $25,000 per patient for the payer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Collaboration Between a Health Plan, Oncology Practice, and Comprehensive Genomic Profiling Company from the Payer Perspective. Reitsma, M., Fox, J., Borre, PV., et al.[2023]

Comprehensive genomic profiling (CGP) of 51 lung adenocarcinoma patients revealed that 58% of those previously negative for EGFR/KRAS/ALK had actionable genomic alterations, indicating potential benefits from targeted therapies.

The study identified a total of 190 genomic alterations, with TP53 mutations being the most common, highlighting the importance of CGP in uncovering additional treatment options for patients with advanced lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genomic profiling of lung adenocarcinoma patients reveals therapeutic targets and confers clinical benefit when standard molecular testing is negative. Lim, SM., Kim, EY., Kim, HR., et al.[2022]

Comprehensive genomic profiling (CGP) was successfully performed on 6,832 NSCLC cases, revealing that 71% of patients had at least one genomic alteration in key driver genes, supporting the NCCN guidelines for targeted testing.

CGP not only detects known driver mutations but also identifies additional alterations in 'pan-negative' lung adenocarcinoma cases, potentially guiding patients towards mechanism-driven clinical trials without requiring extra tissue samples.

NCBI (Pubmed)

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. Suh, JH., Johnson, A., Albacker, L., et al.[2019]

Comprehensive genomic profiling (CGP) panels can identify previously undetected driver mutations in thoracic malignancies, leading to new treatment options for 10% of patients, particularly in lung cancer.

CGP results may help predict the effectiveness of immune checkpoint inhibitors (ICIs), as certain mutations were associated with reduced ICI efficacy, highlighting the importance of CGP in guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of comprehensive genomic profiling panel to thoracic malignancies: A single-center retrospective study. Kunimasa, K., Sugimoto, N., Kawamura, T., et al.[2023]

In a study of 1353 NSCLC patients, a total of 2328 genetic alterations were identified, highlighting the genetic diversity and complexity of this cancer, particularly with co-occurring mutations like TP53 and ALK fusions.

The presence of dual EGFR mutations showed variability in their allele fractions, which may influence treatment responses to targeted therapies, suggesting that genetic profiling could be crucial for personalized treatment strategies in NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-occurring genetic alterations and primary EGFR T790M mutations detected by NGS in pre-TKI-treated NSCLCs. Tang, Y., Che, N., Yu, Y., et al.[2020]

In a study of 180 patients with untreated advanced solid tumors, comprehensive genomic profiling (CGP) identified actionable genomic alterations in 100% of cases, indicating its high utility in guiding treatment decisions.

The study found that 61% of patients received molecular-based recommended therapy (MBRT) based on CGP results, suggesting that CGP can effectively inform personalized treatment strategies for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-Line Genomic Profiling in Previously Untreated Advanced Solid Tumors for Identification of Targeted Therapy Opportunities. Matsubara, J., Mukai, K., Kondo, T., et al.[2023]

A new workflow for next-generation sequencing (NGS) of lung cancer patients significantly reduced the time from biopsy to results, with a median interval of just 10.7 days, and some results available within a week.

This expedited process allowed 93% of patients with actionable genetic alterations to start first-line targeted therapy quickly, with a median treatment initiation time of 19.7 days, highlighting the effectiveness of using frozen tissue for rapid molecular analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expediting Comprehensive Molecular Analysis to Optimize Initial Treatment of Lung Cancer Patients With Minimal Smoking History. Dagogo-Jack, I., Robinson, H., Mino-Kenudson, M., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12476845/

Comprehensive Genomic Profiling in Advanced Non‐Small ... The prognosis for lung cancer has improved in recent years, partly due to the identification of several driver mutations and targeted therapies, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525157825001655

Cost-effectiveness Analysis of Comprehensive Genomic ... Using real-world evidence, this study compared the cost-effectiveness of comprehensive genomic profiling (CGP) versus small panel (SP) testing ...

3. lungcancerjournal.info lungcancerjournal.info/article/S0169-5002(25)00002-9/fulltext

Genomic analysis of comprehensive next generation ... We explored the genomic landscape of METamp NSCLC including degree of amplification, co-drivers, amplicon size, and outcomes to MET inhibitors.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.9126

Clinical and economic outcomes associated with upfront ... Clinical and economic outcomes associated with upfront comprehensive genomic profiling in newly diagnosed advanced lung cancer in the United States from 2018- ...

5. jmdjournal.org jmdjournal.org/article/S1525-1578(25)00165-5/abstract

Cost-Effectiveness Analysis of Comprehensive Genomic ... Using real-world evidence, this study compared the cost-effectiveness of comprehensive genomic profiling (CGP) versus small panel (SP) testing ...

6. illumina.com illumina.com/areas-of-interest/cancer/ngs-in-oncology/cgp.html

Comprehensive Genomic Profiling (CGP) | Cancer ... This next-generation sequencing approach consolidates hundreds of cancer-related markers, including different variant types, into a single assay.

7. nature.com nature.com/articles/s41698-025-00942-5

Tumor diagnosis recharacterization enabled by ... Comprehensive genomic profiling (CGP) via next-generation sequencing is standard clinical practice for advanced and metastatic cancers in the US.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2949820124000353

Clinical impact for advanced non-small-cell lung cancer ... To this effect, comprehensive genomic profiling (CGP) has emerged as a streamlined workflow to test for all relevant tumor biomarkers within a single assay.