MYLUNG Consortium Study Protocol 2

NCT05644808 | Active Not Recruiting

• 1 other identifier: 20381
• Study Type: observational
• Target: 1,002
• Locations: 1 country
• Sites: 18

Brief Summary

This pragmatic study looks to quantify the testing timeline, operational barriers, and outcomes of biomarker-guided therapy in a large, community-based, and largely unselected patient population with early stage and advanced stage, treatment-naive non-small cell lung cancer, whether squamous or non-squamous.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell Lung; Non-Small Cell Lung Cancer; Non-Small Cell Lung Carcinoma; Non-Small-Cell Lung Carcinoma; Nonsmall Cell Lung Cancer; Lung Cancer; Squamous Non-small Cell Lung Cancer; Non-squamous Non-small Cell Lung Cancer; Biomarker Testing; Tumor Tissue Testing

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Who Do and Do Not Receive Biomarker Test Results Prior to Systemic Therapy or Death

  i. Comprehensive testing is defined as both PD-L1 testing to guide use of immunotherapies \& testing for all genomic alterations for which we have FDA-approved therapies incl EGFR, ALK, ROS1, BRAF, NTRK, RET, KRAS \& MET ii. Document whether patient receives single gene testing for actionable mutations compared to those who receive comprehensive testing. For patients who start systemic therapy prior to or without biomarker results, we will catalog reasons for not conducting testing incl: 1. Clinical deterioration, clinical crisis 2. Insufficient tissue 3. Barriers to test ordering 1. Tissue: obtaining sample, tissue retrieval 2. Assay failure for 1 or more biomarkers: Quantity Not Sufficient (QNS), QA fail, test failure 3. Patient/provider attitudes \& perceptions 4. Provider knowledge about testing options 5. Patient knowledge about biomarker testing 6. Payor Coverage: prior authorization denial, payor refusal 7. Financial barriers: uncovered costs, reimbursement

  5 years from date of enrollment into study

Secondary Outcomes (3)

• Proportion of patients placed on biomarker-directed first treatment regimen vs those who were not

  5 years from date of enrollment into study

• Time span between first systemic therapy as compared to date of initial presentation, date of diagnostic biopsy, date of first visit to a medical oncologist, and date of biomarker test order(s) and result(s).

  5 years from date of enrollment into study

• Determine the variance in biomarker test order practice patterns by community cancer clinic settings as measured by percentage of comprehensive testing ordered, type of test ordered, and resulting treatment assigned to the patient.

  5 years from date of enrollment into study

Study Arms (1)

Non-small Cell Lung Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This pragmatic study looks to quantify the testing timeline, operational barriers, and outcomes of biomarker-guided therapy in a large, community-based, and largely unselected patient population with early stage and advanced stage, treatment naive non-small cell lung cancer.

You may qualify if:

• Adult subjects (18 years and older) with newly diagnosed early stage, locally advanced or metastatic non-small cell lung cancer
• Eligible for systemic therapy based on the treating provider's assessment
• Subjects who developed locally advanced or metastatic disease after receiving adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of locally advanced or metastatic disease
• Subjects may be enrolled within 30 days of initiation of systemic therapy
• Signed informed consent

You may not qualify if:

• Stage IA at the time of enrollment
• Subjects with small cell lung cancer
• Subjects with Unknown primary tumor origin

Sponsors & Collaborators

• US Oncology Research: lead

Study Sites (18)

Southern Cancer Center, PC

Daphne, Alabama, 36526, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Woodlands Medical Specialists, PA

Pensacola, Florida, 32503, United States

Location

Illinois Cancer Specialists

Niles, Illinois, 60714, United States

Location

Maryland Oncology Hematology, P.A.

Silver Spring, Maryland, 20904, United States

Location

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, 55404, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12208, United States

Location

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45242, United States

Location

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401, United States

Location

Texas Oncology - West Texas

Abilene, Texas, 79606, United States

Location

Texas Oncology- DFWW

Arlington, Texas, 76012, United States

Location

Texas Oncology-Dallas Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology - Fort Worth Cancer Center

Fort Worth, Texas, 76104, United States

Location

Texas Oncology-McAllen

McAllen, Texas, 78503, United States

Location

Texas Oncology- Northeast Texas

Tyler, Texas, 75702, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

Virginia Oncology Associates

Newport News, Virginia, 23606, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Makenzi Evangelist, MD

  New York Oncology Hematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 9, 2022
• Study Start: December 29, 2020
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

US (18)