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Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer

Primary Purpose

Lung; Node, Adenocarcinoma of Lung

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DetermaRX
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung; Node focused on measuring Biomarkers, Lung Cancer Biomarkers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Participants must have adequate organ and bone marrow function as defined below: a. absolute neutrophil count ≥1,000/mcL b. platelets ≥70,000/mcL c. total bilirubin ≤ institutional upper limit of normal (ULN) d. AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN e. creatinine 3.0 ≤ institutional ULN Agree to participate in the follow-up protocol. Any 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 have had chemotherapy or radiotherapy within 2 years of entering the study. Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1), with the exception of alopecia. Participants who are actively receiving any cancer treatment. History of allergic reactions attributed to adjuvant chemotherapy agents used in study. 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. Pregnant or lactating female. Patient unable to provide informed consent. Prisoner or incarcerated individual. For surgical patients, a R1 or R2 resection.

Sites / Locations

  • Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

High-Risk for Recurrence That Accept Adjuvant Chemotherapy

High-Risk for Recurrence That Decline Adjuvant Chemotherapy

Low-Risk for Recurrence

Arm Description

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 and the potential referral to a medical oncologist are part of this study.

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.

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.

Outcomes

Primary Outcome Measures

Disease Free Survival
Disease-free survival (DFS) is defined as the time from surgical resection and adjuvant chemotherapy to recurrence of tumor or death
Overall Survival
Overall survival (OS) is defined as the time (days) from the date of surgical resection and adjuvant chemotherapy to the date of death, due to any reason.

Secondary Outcome Measures

Tumor Malignancy
Fisher exact test will used to test association of both LCDT1™ and NodifyXL2® blood tests with malignancy.
Cancer Recurrence
Fisher exact test will used to test association of LCDT-1™ blood test with cancer recurrence.

Full Information

First Posted
December 19, 2022
Last Updated
October 17, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05665504
Brief Title
Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
Official Title
Phase 2: Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
February 2028 (Anticipated)
Study Completion Date
February 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed 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 use another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer so that they can be offered additional drug treatment that will improve their chances of long-term cure. Finally, investigators plan to use one of the blood-based biomarkers to detect any late cancer recurrence

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung; Node, Adenocarcinoma of Lung
Keywords
Biomarkers, Lung Cancer Biomarkers

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-Risk for Recurrence That Accept Adjuvant Chemotherapy
Arm Type
Experimental
Arm Description
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 and the potential referral to a medical oncologist are part of this study.
Arm Title
High-Risk for Recurrence That Decline Adjuvant Chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Low-Risk for Recurrence
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
DetermaRX
Intervention Description
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 Information:
Title
Disease Free Survival
Description
Disease-free survival (DFS) is defined as the time from surgical resection and adjuvant chemotherapy to recurrence of tumor or death
Time Frame
Up to 5 years
Title
Overall Survival
Description
Overall survival (OS) is defined as the time (days) from the date of surgical resection and adjuvant chemotherapy to the date of death, due to any reason.
Time Frame
Up to 5 Years
Secondary Outcome Measure Information:
Title
Tumor Malignancy
Description
Fisher exact test will used to test association of both LCDT1™ and NodifyXL2® blood tests with malignancy.
Time Frame
At 6 Months
Title
Cancer Recurrence
Description
Fisher exact test will used to test association of LCDT-1™ blood test with cancer recurrence.
Time Frame
At 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Participants must have adequate organ and bone marrow function as defined below: a. absolute neutrophil count ≥1,000/mcL b. platelets ≥70,000/mcL c. total bilirubin ≤ institutional upper limit of normal (ULN) d. AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN e. creatinine 3.0 ≤ institutional ULN Agree to participate in the follow-up protocol. Any 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 have had chemotherapy or radiotherapy within 2 years of entering the study. Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1), with the exception of alopecia. Participants who are actively receiving any cancer treatment. History of allergic reactions attributed to adjuvant chemotherapy agents used in study. 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. Pregnant or lactating female. Patient unable to provide informed consent. Prisoner or incarcerated individual. For surgical patients, a R1 or R2 resection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brianna Aponte
Phone
813-745-0787
Email
Brianna.Aponte@moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lary A Robinson, MD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brianna Aponte
Phone
813-745-0787
Email
Brianna.Aponte@moffitt.org
First Name & Middle Initial & Last Name & Degree
Lary A Robinson, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://moffitt.org/clinicaltrialssearch?DiseaseSite=&q=21767&SortCriteria=
Description
Moffitt Cancer Center Clinical Trial Search

Learn more about this trial

Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer

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