What side effects are associated with this type of intervention?

Common treatments for lung adenocarcinoma, such as chemotherapy, immune checkpoint inhibitors, and targeted therapies, have various side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infection. Immune checkpoint inhibitors, like pembrolizumab, may lead to immune-related adverse events including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Targeted therapies, such as those for ALK-rearranged NSCLC, can cause gastrointestinal issues, liver enzyme abnormalities, and fatigue. It is important for patients to discuss these potential side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

For the treatment of Lung Adenocarcinoma, the FDA has approved several targeted therapies and immunotherapies. Notable approvals include pembrolizumab, an anti-PD-1 therapy, which has shown efficacy in combination with chemotherapy for advanced non-small-cell lung cancer (NSCLC). Additionally, fam-trastuzumab deruxtecan, a HER2-targeted antibody-drug conjugate, is approved for patients with HER2-mutant NSCLC. These treatments align with ongoing research into diagnostic and prognostic biomarkers, aiming to personalize therapy based on specific genetic mutations and protein expressions in tumors.

What other types of research exist?

Promising novel alternatives to biomarker evaluation for lung adenocarcinoma patients include next-generation imaging techniques such as integrated PET/CT or PET/MRI using advanced radiotracers, which offer higher sensitivity in detecting metastases. Additionally, the use of liquid biopsies for circulating tumor DNA (ctDNA) analysis is emerging as a non-invasive method to monitor tumor dynamics and treatment response. These methods provide enhanced diagnostic accuracy and prognostic information, potentially improving patient outcomes.

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Biomarker Test

Biomarker Testing with DetermaRX for Lung Cancer Monitoring

N/A

Recruiting

Led By Lary A Robinson, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Potentially-resectable lung nodule 8-40 mm diameter suspected of being a clinically node-negative lung cancer (clinical stage IA-IB)

Any suspected primary lung cancer cell type (except typical carcinoid tumor, carcinoma in situ or minimally-invasive carcinoma)

Must not have

Unable to provide informed consent

Suspected typical carcinoid cell type

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is an observational study focusing on diagnostic biomarkers rather than treatments like drugs or surgeries (beyond standard care), it does not introduce additional side effects related directly to the interventions being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am fully active or can carry out light work.

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I am recommended to have SBRT at Moffitt Cancer Center instead of surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand and give consent for treatment.

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My tumor is suspected to be a typical carcinoid.

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I am currently undergoing cancer treatment.

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My surgery left some cancer cells behind.

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My scans show nodules or masses near my lung's air passages.

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I do not have any active cancer except for non-melanoma skin cancer.

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I had lung cancer within the last 5 years.

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I do not have any uncontrolled illnesses.

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My cancer has spread to my lung from another part of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Free Survival

Overall Survival

Secondary study objectives

Cancer Recurrence

Tumor Malignancy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Low-Risk for RecurrenceExperimental Treatment1 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 ChemotherapyExperimental Treatment1 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 ChemotherapyExperimental Treatment1 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.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Lung Adenocarcinoma include targeted therapies and immunotherapies. Targeted therapies, such as EGFR tyrosine kinase inhibitors, block the activity of specific proteins that are mutated and overactive in cancer cells, thereby inhibiting tumor growth. Immunotherapies, like PD-1/PD-L1 inhibitors, enhance the immune system's ability to recognize and destroy cancer cells by preventing the interaction between PD-1 on immune cells and PD-L1 on cancer cells. These treatments are particularly important for patients with specific genetic mutations or high PD-L1 expression, as they can offer more effective and personalized treatment options with potentially fewer side effects compared to traditional chemotherapy.