MYLUNG Consortium Study Protocol 2

Carcinoma, Non-Small-Cell Lung Clinical Trial

— MYLUNG  

Official title:

Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Prospective RWE Study (MYLUNG Consortium: Part 2)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05644808
• Other study ID #: 20381
• Status: Active, not recruiting
• Start date: December 29, 2020
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: US Oncology Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Lung cancer remains the most lethal malignancy in men and women in the U.S. Providing high quality management of these patients in the community setting as compared to hospital or academic centers offers the opportunity to reduce cost without sacrificing clinical outcome and simultaneously improving patient convenience and value. Many patients diagnosed with late-stage cancers can benefit from advanced biomarker testing, yet not all eligible patients receive this type of diagnostic testing today.

Within advanced non-small-cell lung cancer (aNSCLC), there are many specific somatic mutations observed in select patient populations that have targeted highly effective and less toxic therapies. National guidelines have advocated for broad tumor molecular profiling as a part of the standard diagnostic evaluation for aNSCLC, with the goal of identifying driver mutations for which effective therapies or clinical trials are available.

Furthermore, there is emerging evidence that molecular testing can impact treatment choices in earlier stages of lung cancer. However, adherence to genomic testing guidelines presents unique challenges to community oncologists. While most oncology clinical research has been conducted at well-established academic medical centers, over 85% of cancer patients are diagnosed and treated at local, community-based clinical practices. Barriers exist in the ability to order these tests efficiently, in a timely manner, and reimbursed accordingly. Furthermore, patient care can vary drastically based on community-associated disparities.

This pragmatic clinical trial will generate Real World Evidence (RWE) to validate efficacy of first treatment regimen in newly diagnosed patients with non-small cell lung cancer. The MYLUNG Program integrates three separate protocols: Protocol #1 will interrogate historical data from a large number of practices seeing lung cancer patients to evaluate biomarker testing, decision making patterns, the patient journey, and the tissue journey; Protocol #2 (current trial) will prospectively evaluate the patient journey in a limited number of index practices focused on testing; integration of testing results; and treatments. Interventional strategies to optimize these objectives will be developed and integrated into Protocol #3, which will evaluate the impact of these strategies on the patient journey as it relates to shared decision making.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1002
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Stage IA at the time of enrollment

• Subjects with small cell lung cancer

• Subjects with Unknown primary tumor origin

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
United States	Texas Oncology - West Texas	Abilene	Texas
United States	New York Oncology Hematology, P.C.	Albany	New York
United States	Texas Oncology- DFWW	Arlington	Texas
United States	Oncology Hematology Care Clinical Trials, LLC	Cincinnati	Ohio
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology-Dallas Presbyterian Hospital	Dallas	Texas
United States	Southern Cancer Center, PC	Daphne	Alabama
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	Texas Oncology - Fort Worth Cancer Center	Fort Worth	Texas
United States	Texas Oncology-McAllen	McAllen	Texas
United States	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota
United States	Virginia Oncology Associates	Newport News	Virginia
United States	Illinois Cancer Specialists	Niles	Illinois
United States	Woodlands Medical Specialists, PA	Pensacola	Florida
United States	Maryland Oncology Hematology, P.A.	Silver Spring	Maryland
United States	Texas Oncology- Northeast Texas	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
US Oncology Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Clinical deterioration, clinical crisis; Insufficient tissue; Barriers to test ordering; Tissue: obtaining sample, tissue retrieval; Assay failure for 1 or more biomarkers: Quantity Not Sufficient (QNS), QA fail, test failure; Patient/provider attitudes & perceptions; Provider knowledge about testing options; Patient knowledge about biomarker testing; Payor Coverage: prior authorization denial, payor refusal; Financial barriers: uncovered costs, reimbursement	5 years from date of enrollment into study
Secondary	Proportion of patients placed on biomarker-directed first treatment regimen vs those who were not	To determine the proportion of patients placed on biomarker-directed first treatment regimen. For patients who have received biomarker test results with at least one actionable mutation, catalog the reason for not prescribing biomarker-targeted therapy.; i. Lack of availability or delays in obtaining targeted therapy ii. Misinterpretation of test results iii. Clinical contraindications (allergies, end organ dysfunction, active autoimmune disease, etc.) iv. Patient/provider attitudes and perceptions v. Financial barriers / Uncovered costs vi. Patient performance status	5 years from date of enrollment into study
Secondary	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
Secondary	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.	Characteristics of the cancer care practices include, but not limited to, number of geographic clinic locations, clinical settings (rural or urban), staffing and responsibilities, patient volumes, and Oncology Care Model (OCM) status.	5 years from date of enrollment into study