Clinical trial NCT05644808: MYLUNG Consortium Study Protocol 2
Official title: Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Prospective RWE Study (MYLUNG Consortium: Part 2)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: US Oncology Research
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 1002
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Proportion of Patients Who Do and Do Not Receive Biomarker Test Results Prior to Systemic Therapy or Death
timeFrame: 5 years from date of enrollment into study
Secondary outcomes:
measure: Proportion of patients placed on biomarker-directed first treatment regimen vs those who were not
timeFrame: 5 years from date of enrollment into study
measure: 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).
timeFrame: 5 years from date of enrollment into study
measure: 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.
timeFrame: 5 years from date of enrollment into study
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Pensacola
country: United States
facility: Woodlands Medical Specialists, PA
state: Florida
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Silver Spring
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care Clinical Trials, LLC
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Abilene
country: United States
facility: Texas Oncology - West Texas
state: Texas
city: Arlington
country: United States
facility: Texas Oncology- DFWW
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Dallas Presbyterian Hospital
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology - Fort Worth Cancer Center
state: Texas
city: McAllen
country: United States
facility: Texas Oncology-McAllen
state: Texas
city: Tyler
country: United States
facility: Texas Oncology- Northeast Texas
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
Study officials:
affiliation: New York Oncology Hematology
name: Makenzi Evangelist, MD
role: PRINCIPAL_INVESTIGATOR
References: