Carcinoma, Non-Small-Cell Lung Clinical Trial
— MYLUNGOfficial title:
Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Longitudinal Prospective RWE Study (MYLUNG Consortium Part 3: Observational Study)
NCT number | NCT05885698 |
Other study ID # | 22285 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 30, 2023 |
Est. completion date | December 2030 |
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.
Status | Recruiting |
Enrollment | 7500 |
Est. completion date | December 2030 |
Est. primary completion date | December 2030 |
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 - 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 |
Country | Name | City | State |
---|---|---|---|
United States | New York Oncology Hematology, P.C. | Albany | New York |
United States | Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Blacksburg | Virginia |
United States | Affiliated Oncologists, LLC | Chicago Ridge | Illinois |
United States | Oncology Hematology Care Clinical Trials, LLC | Cincinnati | Ohio |
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 | Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota |
United States | Virginia Oncology Associates | Newport News | Virginia |
United States | Illinois Cancer Specialists | Niles | Illinois |
United States | Cancer Care Centers of Brevard, Inc. | Palm Bay | Florida |
United States | Woodlands Medical Specialists, PA | Pensacola | Florida |
United States | Arizona Oncology Associates, PC - NAHOA | Prescott Valley | Arizona |
United States | Maryland Oncology Hematology, P.A. | Silver Spring | Maryland |
United States | Northwest Cancer Specialists, P.C. | Vancouver | Washington |
United States | Shenandoah Oncology, P.C. | Winchester | Virginia |
Lead Sponsor | Collaborator |
---|---|
US Oncology Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients Who Receive Biomarker Test Results Prior to Systemic Therapy or Death | 5 years from date of enrollment into study | ||
Primary | Proportion of Patients Who Receive Single-gene Testing Compared to Those that Receive Comprehensive Biomarker Testing | Comprehensive biomarker testing is defined as both PD-L1 testing to guide the use of immunotherapies and testing for all genomic alterations for which there are FDA-approved therapies including (but not limited to) EGFR, ALK, ROS1, BRAF, NTRK, RET, KRAS and MET. | 5 years from date of enrollment into study | |
Primary | For Patients without Biomarker Test Results, List Reasons for Not Conducting Testing | Clinical deterioration, clinical crisis Tissue: obtaining sample, tissue retrieval Assay failure for 1 or more biomarkers: Quantity Not Sufficient (QNS), Quality Assurance (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 | 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 | For Patients who Receive Comprehensive Biomarker Testing, list Types of Test Ordered | 5 years from date of enrollment into study | ||
Secondary | For Patients without Biomarker-Directed First Treatment Regimen, Catalog Reasons for Not Prescribing Biomarker-Targeted Therapy | For patients who have received biomarker test results with at least one actionable mutation, catalog the reason for not prescribing biomarker-targeted therapy. Lack of availability or delays in obtaining targeted therapy Misinterpretation of test results Clinical contraindications (allergies, end organ dysfunction, active autoimmune disease, etc.) Patient/provider attitudes and perceptions Financial barriers / Uncovered costs Patient performance status |
5 years from date of enrollment into study | |
Secondary | For Patients who Receive Comprehensive Biomarker Testing, list Types of Resulting Treatment Regimen Assigned | 5 years from date of enrollment into study | ||
Secondary | Characteristics of Cancer Care Practices: Number of Geographic Clinical Locations Per Practice | 5 years from date of enrollment into study | ||
Secondary | Characteristics of Cancer Care Practices: Rural Setting vs Urban Setting at each Practice | 5 years from date of enrollment into study | ||
Secondary | Characteristics of Cancer Care Practices: Number of Staff per Practice | 5 years from date of enrollment into study | ||
Secondary | Characteristics of Cancer Care Practices: Patient Volume per Practice | 5 years from date of enrollment into study |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04879849 -
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
|
Phase 1 | |
Completed |
NCT04426825 -
A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
|
Phase 2 | |
Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
Completed |
NCT02810457 -
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02864394 -
Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
|
Phase 3 | |
Recruiting |
NCT04592523 -
A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
|
||
Recruiting |
NCT04838548 -
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT04077463 -
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT05167604 -
Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
|
||
Recruiting |
NCT04603807 -
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
|
Phase 3 | |
Completed |
NCT04948411 -
Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
|
||
Active, not recruiting |
NCT04487080 -
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Not yet recruiting |
NCT04255836 -
Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
|
Phase 2 | |
Completed |
NCT01953913 -
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
|
Phase 3 | |
Recruiting |
NCT05715229 -
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
|
Phase 2 | |
Recruiting |
NCT04931654 -
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
|
Phase 1/Phase 2 | |
Suspended |
NCT05421936 -
Osimertinib for NSCLC With Uncommon EGFR Mutations
|
||
Completed |
NCT02847377 -
A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
|
N/A | |
Completed |
NCT04427072 -
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
|
Phase 3 | |
Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A |