Trial Title:
MYLUNG Consortium Study Protocol 2
NCT ID:
NCT05644808
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Conditions: 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
Study type:
Observational [Patient Registry]
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Southern Cancer Center, PC
Address:
City:
Daphne
Zip:
36526
Country:
United States
Facility:
Name:
Rocky Mountain Cancer Center
Address:
City:
Denver
Zip:
80218
Country:
United States
Facility:
Name:
Woodlands Medical Specialists, PA
Address:
City:
Pensacola
Zip:
32503
Country:
United States
Facility:
Name:
Illinois Cancer Specialists
Address:
City:
Niles
Zip:
60714
Country:
United States
Facility:
Name:
Maryland Oncology Hematology, P.A.
Address:
City:
Silver Spring
Zip:
20904
Country:
United States
Facility:
Name:
Minnesota Oncology Hematology, P.A.
Address:
City:
Minneapolis
Zip:
55404
Country:
United States
Facility:
Name:
New York Oncology Hematology, P.C.
Address:
City:
Albany
Zip:
12208
Country:
United States
Facility:
Name:
Oncology Hematology Care Clinical Trials, LLC
Address:
City:
Cincinnati
Zip:
45242
Country:
United States
Facility:
Name:
Willamette Valley Cancer Institute and Research Center
Address:
City:
Eugene
Zip:
97401
Country:
United States
Facility:
Name:
Texas Oncology - West Texas
Address:
City:
Abilene
Zip:
79606
Country:
United States
Facility:
Name:
Texas Oncology- DFWW
Address:
City:
Arlington
Zip:
76012
Country:
United States
Facility:
Name:
Texas Oncology-Dallas Presbyterian Hospital
Address:
City:
Dallas
Zip:
75231
Country:
United States
Facility:
Name:
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Address:
City:
Dallas
Zip:
75246
Country:
United States
Facility:
Name:
Texas Oncology - Fort Worth Cancer Center
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Facility:
Name:
Texas Oncology-McAllen
Address:
City:
McAllen
Zip:
78503
Country:
United States
Facility:
Name:
Texas Oncology- Northeast Texas
Address:
City:
Tyler
Zip:
75702
Country:
United States
Facility:
Name:
Virginia Cancer Specialists, PC
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Facility:
Name:
Virginia Oncology Associates
Address:
City:
Newport News
Zip:
23606
Country:
United States
Start date:
December 29, 2020
Completion date:
December 2027
Lead sponsor:
Agency:
US Oncology Research
Agency class:
Industry
Source:
US Oncology Research
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05644808
