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

Trial Summary

What is the purpose of this trial?

This trial studies certain indicators in blood and tissue to see if they can signal lung cancer or predict its return. It focuses on patients with lung nodules and those who have had lung cancer surgery. Researchers hope these indicators can help detect cancer early and identify high-risk patients.

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 data supports the effectiveness of the treatment DetermaRX for lung cancer monitoring?

The research highlights the importance of biomarker testing in lung cancer, which can help tailor treatments to individual patients. Although specific data on DetermaRX is not provided, the use of companion diagnostics in lung cancer has shown real-world benefits by identifying patients who are more likely to respond to targeted treatments. ^{1 2 3 4 5}

What makes the treatment DetermaRX unique for lung cancer monitoring?

DetermaRX is unique because it focuses on using biomarker testing to monitor lung cancer, which involves analyzing specific biological markers in the body to track the disease's progression and response to treatment. This approach is different from traditional treatments that may not utilize such targeted biomarker analysis for monitoring. ^{1 2 6 7 8}

Research Team

Lary Robinson, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

New approaches for biomarker discovery in lung cancer. [2015]

2. United States 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. [2022]

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

Biomarkers of resistance to immune checkpoint inhibitors in non-small-cell lung cancer: myth or reality? [2022]

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

A new BATTLE in the evolving war on cancer. [2018]

5. England 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Use of cytology fluid samples for predictive biomarker testing in lung cancer patients. [2023]

7. Greece pubmed.ncbi.nlm.nih.gov

Transcriptomic Analysis in Liquid Biopsy Identifies Circulating PCTAIRE-1 mRNA as a Biomarker in NSCLC. [2020]

8. France pubmed.ncbi.nlm.nih.gov

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