Trial Title:
MYLUNG Consortium Part 3: Observational Study
NCT ID:
NCT05885698
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:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
This longitudinal 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 longitudinal 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 interrogated
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 prospectively evaluated 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 various interventions all aimed at improving biomarker testing rates. Protocol #3
(22285) will serve as a resource to monitor the impact of these strategies on the patient
journey as it relates to shared decision making, and will continue to prospectively
evaluate the patient journey in a limited number of index practices focused on testing,
integration of testing results and treatments.
Criteria for eligibility:
Study pop:
This longitudinal 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
- Must be eligible for systemic therapy based on the treating provider's assessment.
If systemic therapy was recommended and documented by the treating provider but the
patient declined, they can still be eligible for the study. Patients can be enrolled
prior to start of treatment.
- 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 must 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
Status:
Recruiting
Contact:
Last name:
Karla Childers
Phone:
251-433-9899
Email:
karla.childers@usoncology.com
Investigator:
Last name:
Michael Meshad, MD
Email:
Principal Investigator
Facility:
Name:
Arizona Oncology Associates, PC - NAHOA
Address:
City:
Prescott Valley
Zip:
86314
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Erika Arguello Vargas
Phone:
928-775-9430
Email:
erika.arguellovargas@usoncology.com
Investigator:
Last name:
Allan V. Espinosa Morazan, MD
Email:
Principal Investigator
Facility:
Name:
Rocky Mountain Cancer Center
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Cancer Care Centers of Brevard, Inc.
Address:
City:
Palm Bay
Zip:
32901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karla Childers
Phone:
251-433-9899
Email:
karla.childers@usoncology.com
Investigator:
Last name:
Venkat Pavan R. Kancharla, MD
Email:
Principal Investigator
Facility:
Name:
Woodlands Medical Specialists, PA
Address:
City:
Pensacola
Zip:
32503
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Affiliated Oncologists, LLC
Address:
City:
Chicago Ridge
Zip:
60415
Country:
United States
Status:
Recruiting
Contact:
Last name:
Angela Malone
Phone:
708-424-9710
Email:
Angela.Malone@usoncology.com
Investigator:
Last name:
Rami Y. Haddad, MD
Email:
Principal Investigator
Facility:
Name:
Illinois Cancer Specialists
Address:
City:
Niles
Zip:
60714
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Maryland Oncology Hematology, P.A.
Address:
City:
Silver Spring
Zip:
20904
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Minnesota Oncology Hematology, P.A.
Address:
City:
Minneapolis
Zip:
55404
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
New York Oncology Hematology, P.C.
Address:
City:
Albany
Zip:
12208
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ambri Cicchinelli
Phone:
518-262-6696
Email:
ambri.cicchinelli@usoncology.com
Investigator:
Last name:
Makenzi Evangelist, MD
Email:
Principal Investigator
Facility:
Name:
Oncology Hematology Care Clinical Trials, LLC
Address:
City:
Cincinnati
Zip:
45242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sara Gonce
Phone:
513-751-2273
Email:
Sara.Gonce@usoncology.com
Investigator:
Last name:
Patrick J. Ward, MD
Email:
Principal Investigator
Facility:
Name:
Willamette Valley Cancer Institute and Research Center
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jeanne Schaffer
Phone:
541-683-5001
Email:
jeanne.schaffer@usoncology.com
Investigator:
Last name:
James E. Butrynski, MD
Email:
Principal Investigator
Facility:
Name:
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Address:
City:
Blacksburg
Zip:
24060
Country:
United States
Status:
Recruiting
Contact:
Last name:
Natasha R. Holt
Phone:
540-982-0237
Email:
natasha.holt@usoncology.com
Investigator:
Last name:
Jerome H. Goldschmidt, Jr., MD
Email:
Principal Investigator
Facility:
Name:
Virginia Cancer Specialists, PC
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Virginia Oncology Associates
Address:
City:
Newport News
Zip:
23606
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ebony Villarson
Phone:
757-873-9810
Email:
ebony.villarson@usoncology.com
Investigator:
Last name:
John C. Paschold, MD
Email:
Principal Investigator
Facility:
Name:
Shenandoah Oncology, P.C.
Address:
City:
Winchester
Zip:
22601
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Northwest Cancer Specialists, P.C.
Address:
City:
Vancouver
Zip:
98684
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julian Kern
Phone:
360-597-1300
Email:
julian.kern@usoncology.com
Investigator:
Last name:
Anthony Van Ho, MD
Email:
Principal Investigator
Start date:
January 30, 2023
Completion date:
December 2030
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/NCT05885698
