Biomarker Testing with DetermaRX for Lung Cancer Monitoring

Overseen By Brianna Aponte

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Active cancer treatment, Uncontrolled illness, Prior lung cancer, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to monitor lung cancer using specific markers in blood and tumor tissue. Researchers seek to determine if these markers can identify whether a lung nodule (a small lump) is cancerous and predict the likelihood of cancer returning after surgery. The study involves different risk-based groups, with some receiving follow-up and others potentially receiving treatments like chemotherapy. Ideal candidates have a diagnosed lung nodule measuring 8-40 mm and plan to undergo surgery at Moffitt Cancer Center. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage advancements in lung cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are actively receiving any cancer treatment, you would not be eligible to participate.

What prior data suggests that DetermaRX is safe for lung cancer monitoring?

Research has shown that DetermaRX is a safe and easy-to-use test, aiding doctors in selecting the best treatment plan for lung cancer patients. Studies have found that DetermaRX accurately identifies patients at high risk of cancer recurrence after surgery.

Medicare covers the DetermaRX test, indicating its trustworthiness and common use in healthcare. Importantly, no reports indicate the test causes harm or side effects. It helps determine who might need additional treatment after surgery.

In summary, DetermaRX is a safe and effective test for guiding lung cancer treatment decisions, without requiring medication or invasive procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DetermaRX trial because it offers a personalized approach to lung cancer monitoring, focusing on genetic markers to assess recurrence risk. Unlike traditional treatments like surgery and chemotherapy that are applied broadly, DetermaRX uses a gene assay to determine if a patient is at low or high risk for cancer returning. This targeted assessment helps tailor follow-up treatment plans, potentially sparing some patients from unnecessary chemotherapy while ensuring others receive additional care based on their specific genetic profile. This individualized strategy could lead to better outcomes by aligning treatment with each patient's unique tumor characteristics.

What evidence suggests that DetermaRX is effective for lung cancer monitoring?

Research has shown that DetermaRX can significantly improve the survival of lung cancer patients. In this trial, DetermaRX guides treatment decisions for individuals with non-small cell lung cancer (NSCLC). Participants with a gene assay indicating a lower risk of recurrence will not receive additional treatment after resection. Those at higher risk will be offered postoperative chemotherapy, and if they have a specific mutation (EGFR), they may also receive an oral anti-EGFR pill (TagrissoTM). Studies have found that combining DetermaRX results with information about specific gene changes helps doctors select the best treatments, which has been linked to higher survival rates. Although the treatment remains under study, current evidence suggests it could significantly benefit patients. ^{2 4 6 7 8}

Who Is on the Research Team?

Lary Robinson, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults who may have early-stage lung cancer, with a lung nodule sized 8-40 mm and no spread to lymph nodes. They must be fit enough for surgery or radiotherapy at Moffitt Cancer Center, able to follow up, and consent to the study. Excluded are those with certain types of nodules, other active major cancers, prior lung cancer within 5 years, ongoing cancer treatment, inability to consent or incarceration.

Inclusion Criteria

I have a lung nodule between 8-40 mm suspected to be early-stage cancer.

My lung cancer is not a typical carcinoid, carcinoma in situ, or minimally-invasive.

I am over 18 years old.

Exclusion Criteria

I am currently undergoing cancer treatment.

My surgery left some cancer cells behind.

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biomarker Evaluation

Evaluation of blood and tissue biomarkers to determine cancer risk and recurrence

6 months

Periodic visits every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Periodic visits every 6-12 months

What Are the Treatments Tested in This Trial?

Interventions

• DetermaRX

Trial Overview The study observes blood and tissue biomarkers in patients. It aims to assess if blood biomarkers can accurately diagnose lung nodules as benign or malignant; identify high recurrence risk post-surgery using tissue biomarkers; and monitor late recurrence through blood markers.

How Is the Trial Designed?

Group I: Low-Risk for Recurrence Experimental Treatment 1 Intervention

Participants whose gene assay show that they are at a lower risk of recurrence will not be offered additional treatment after resection. Investigators will followup with participants periodically every 6-12 months over 5 years.

Group II: High-Risk for Recurrence That Decline Adjuvant Chemotherapy Experimental Treatment 1 Intervention

Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participant declines, investigators will followup with participants periodically every 6-12 months over 5 years.

Group III: High-Risk for Recurrence That Accept Adjuvant Chemotherapy Experimental Treatment 1 Intervention

Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participants also have a special mutation on the tumor (EGFR), investigators will recommend that the participant also receive the oral anti-EGFR pill (TagrissoTM) daily for 3 years after completing the chemotherapy. The administration of standard postoperative chemotherapy is not considered part of the study. Only the results of the DetermaRx test is a part of this study.

DetermaRX is already approved in United States for the following indications:

Approved in United States as DetermaRx for:

• Risk stratification for post-surgical recurrence in early-stage non-small cell lung cancer

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Published Research Related to This Trial

Immune checkpoint inhibitors have significantly advanced treatment for non-small-cell lung cancer, but many patients either do not respond initially or develop resistance over time, highlighting the need for better predictive biomarkers.

Research is ongoing to develop new biomarkers using proteomic, genomic, and transcriptomic methods from tumor and blood samples, which could help tailor therapies and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers of resistance to immune checkpoint inhibitors in non-small-cell lung cancer: myth or reality? Pourmir, I., Gazeau, B., de Saint Basile, H., et al.[2022]

Lung cancer is the leading cause of cancer death globally, and there is currently no effective population-based screening method in place.

The ANTIBIOMIX approach, which utilizes thousands of polyclonal antibodies, shows promise for discovering specific biomarkers in biological samples like sputum and serum, potentially improving early diagnosis and monitoring of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New approaches for biomarker discovery in lung cancer. Valle, RP., Chavany, C., Zhukov, TA., et al.[2015]

The study identified PCTAIRE-1 as a novel circulating mRNA biomarker for non-small cell lung cancer (NSCLC) through plasma RNA profiling in patients, showing a sensitivity of 60% and specificity of 85% for diagnosis.

High levels of PCTAIRE-1 in plasma were associated with poor progression-free survival in NSCLC patients, indicating its potential as a prognostic marker for disease outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcriptomic Analysis in Liquid Biopsy Identifies Circulating PCTAIRE-1 mRNA as a Biomarker in NSCLC. Chang, JW., Shih, CL., Wang, CL., et al.[2020]

Specific carcinogen-derived biomarkers, such as certain DNA adducts and metabolites found in urine, show potential for use in chemoprevention trials against lung and oral cancers, although they have not yet been applied in such trials.

The study highlights the need for further development of additional biomarkers, like tobacco-specific nitrosamine-DNA adducts, to better understand how chemopreventive agents can influence cancer risk by altering carcinogen metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carcinogen biomarkers for lung or oral cancer chemoprevention trials. Hecht, SS.[2015]

The BATTLE trial uses real-time molecular analysis of lung cancer specimens to tailor targeted therapies, enhancing the precision of treatment for patients.

This innovative approach employs an adaptive Bayesian clinical trial design, allowing for adjustments based on ongoing results, which may improve the efficacy of lung cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new BATTLE in the evolving war on cancer. Sequist, LV., Muzikansky, A., Engelman, JA.[2018]

In a study of 17,555 patients with advanced non-small cell lung cancer (aNSCLC), those who underwent companion diagnostic (CDx) testing had a significantly longer median survival of 13.04 months compared to 6.01 months for those without testing, indicating a strong survival benefit from CDx testing.

Patients with CDx testing who received biomarker-driven first-line therapy had a reduced mortality risk (adjusted hazard ratio of 0.72), suggesting that CDx testing is crucial for identifying patients who are more likely to benefit from targeted treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of Precision Medicine in Advanced Non-Small Cell Lung Cancer: Real-World Outcomes Associated with the Use of Companion Diagnostics. John, A., Shah, RA., Wong, WB., et al.[2021]

Cytology fluid samples, including those from endobronchial ultrasound and serous effusions, can be effectively used for predictive biomarker testing in lung cancer patients, yielding valid results for EGFR testing.

Serous fluids were found to provide the best quality DNA for testing, allowing for rapid variant genotype reporting within 150 minutes, demonstrating the method's efficiency and potential for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of cytology fluid samples for predictive biomarker testing in lung cancer patients. Hawkins, P., Stevenson, T., Powari, M.[2023]

In a study of 106 lung cancer patients, endobronchial ultrasound (EBUS) guided needle aspiration yielded the highest RNA quantity for molecular testing compared to forceps biopsy and CT-guided core biopsy, making it a preferred method for obtaining tumor samples.

All three sampling methods successfully provided sufficient tumor material for testing multiple biomarkers, with EBUS showing a significant advantage in RNA yield, which is crucial for accurate molecular analysis in lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EBUS-TBNA provides highest RNA yield for multiple biomarker testing from routinely obtained small biopsies in non-small cell lung cancer patients - a comparative study of three different minimal invasive sampling methods. Schmid-Bindert, G., Wang, Y., Jiang, H., et al.[2022]

Citations

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Genomic profiling for non-small cell lung cancer Despite surgical resection of the tumor, a 5-year mortality rate of 30% to 50% in patients diagnosed with Stage I–IIA NSCLC has been reported ...

2. investors.imdxinc.com investors.imdxinc.com/news-releases/2020/10-14-2020-130251414

Oncocyte Announces New Prospective Data Demonstrating That ... Oncocyte Announces New Prospective Data Demonstrating That Treatment Informed by DetermaRx™ Significantly Improves Lung Cancer Patient Survival. Oct 14, 2020.

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Treatment Informed by DetermaRx Significantly Improves ... Combining DetermaRx risk status with EGFR mutation status may help inform optimal treatment strategies for non-small cell lung cancer (NSCLC) ...

4. thelancet.com thelancet.com/pdfs/journals/eclinm/PIIS2589-5370(23)00382-6.pdf

The impact of adjuvant EGFR-TKIs and 14-gene molecular ... Adjuvant chemotherapy · guided by molecular profiling and improved outcomes in early · stage, non-small-cell lung cancer. Clin Lung Cancer. 2018 ...

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Genomic profiling for non-small cell lung cancer: Clinical... Despite surgical resection of the tumor, a 5-year mortality rate of 30% to 50% in patients diagnosed with Stage I–IIA NSCLC has been reported ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11276127/

Confirmation of Recurrent Lung Cancer Following ... Confirmation of recurrent lung cancer following resection using liquid biopsy, a proof-of-concept real-world study.

7. oncocyte-ocx.reportablenews.com oncocyte-ocx.reportablenews.com/pr/kol-call-oncocyte-cancer

KOL Call on Oncocyte's Proprietary DetermaRx™ and ... DetermaRx™ is a Medicare-reimbursed treatment stratification test that enables the identification of early-stage lung cancer patients at high ...

8. mdpi.com mdpi.com/2072-6694/14/17/4150

Lung Cancer Recurrence Risk Prediction through ... We developed an integrated deep learning evaluation (IDLE) score to combine patient's preoperative lung CT image findings and postoperative pathologic ...