Recruiting

Biomarkers

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT05665504

Conditions

Lung; Node

Adenocarcinoma of Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DetermaRX

Study Details

Brief summary:

This study is an observational study of blood and tissue biomarkers. Investigators plan to evaluate the accuracy of lung cancer biomarkers found in the blood in determining if a lung nodule is cancer or benign. Investigators also plan to examine another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer. Finally, investigators plan to determine if one of the blood-based biomarkers can be used to detect any late cancer recurrence.

Conditions

Lung; Node

Adenocarcinoma of Lung

Study ID

NCT05665504

Start date

Jan 11, 2023

Status verified date

Mar, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Potentially-resectable lung nodule 8-40 mm diameter suspected (no preop diagnosis) of being a clinically node-negative lung cancer \[clinical stage IA-IB (cT1a-T2aN0), <4cm diameter\].
  • If surgical resection is recommended, patient will undergo surgery at Moffitt Cancer Center.
  • If a definite tissue diagnosis is obtained and stereotactic body radiotherapy (SBRT) is the recommended treatment instead of surgery, the SBRT will be delivered at Moffitt Cancer Center.
  • >18 years old, male or female.
  • ECOG performance status 0-1.
  • Agree to participate in the follow-up protocol.
  • Any suspected primary lung cancer cell type (except a suspected typical carcinoid tumor, carcinoma in situ or minimally-invasive carcinoma).
  • Ability to understand and the willingness to sign a written, informed consent document.

Exclusion Criteria:

  • Participants who are actively receiving any cancer treatment.
  • Participants with uncontrolled intercurrent illness.
  • Prior lung cancer within 5 years.
  • Current active other major cancer except non-melanoma skin cancer.
  • Patients with pure ground glass opacities (nodules) or hilar masses.
  • Suspected typical carcinoid cell type (well-differentiated neuroendocrine carcinoma).
  • Metastatic nodule (suspected) in the lung from an extrapulmonary cancer.
  • Patient unable to provide informed consent.
  • Prisoner or incarcerated individual.
  • For surgical patients, a R1 or R2 resection.

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

High-Risk for Recurrence That Accept Adjuvant Chemotherapy

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.

High-Risk for Recurrence That Decline Adjuvant Chemotherapy

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.

Low-Risk for Recurrence

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.

Interventions

DetermaRX

A lung tissue biomarker to risk stratify patients immediately after curative lung cancer resections into groups with low risk versus intermediate-high risk for recurrence of cancer. Intermediate-high risk patients will be advised to undergo adjuvant chemotherapy with the expectation of decreasing their chance of recurrence. The effectiveness and toxicity of the adjuvant chemotherapy itself is considered not part of the study-just the decision to recommend adjuvant chemotherapy is the study intervention. Investigators will then evaluate the long-term survival results of low-risk patients (no adjuvant treatment) and intermediate-high risk patients receiving adjuvant treatment versus intermediate-high risk patients who decline adjuvant therapy.

Primary outcome measure

  • Disease Free Survival [ Time Frame: Up to 5 years ]
  • Overall Survival [ Time Frame: Up to 5 Years ]

Central Contacts and Locations

Central contacts

Brianna Aponte

813-745-0787Brianna.Aponte@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Brianna Aponte

813-745-0787Brianna.Aponte@moffitt.org

Principal Investigator:

Lary A Robinson, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • Biomarkers
  • Lung Cancer Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-04-01.