MYLUNG Consortium Study Protocol 2

NCT ID: NCT05644808

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1002 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-29
• Study Completion Date: 2027-12-31

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.

Detailed 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-small Cell Lung Cancer

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Oncology Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Makenzi Evangelist, MD

Role: PRINCIPAL_INVESTIGATOR

New York Oncology Hematology

Locations

Southern Cancer Center, PC

Daphne, Alabama, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Woodlands Medical Specialists, PA

Pensacola, Florida, United States

Illinois Cancer Specialists

Niles, Illinois, United States

Maryland Oncology Hematology, P.A.

Silver Spring, Maryland, United States

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, United States

New York Oncology Hematology, P.C.

Albany, New York, United States

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

Texas Oncology - West Texas

Abilene, Texas, United States

Texas Oncology- DFWW

Arlington, Texas, United States

Texas Oncology-Dallas Presbyterian Hospital

Dallas, Texas, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Texas Oncology - Fort Worth Cancer Center

Fort Worth, Texas, United States

Texas Oncology-McAllen

McAllen, Texas, United States

Texas Oncology- Northeast Texas

Tyler, Texas, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Virginia Oncology Associates

Newport News, Virginia, United States

Countries

United States

Other Identifiers

20381

Identifier Type: -

Identifier Source: org_study_id