This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MYLUNG Consortium Part 3: Observational Study (MYLUNG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05885698
Recruitment Status : Recruiting
First Posted : June 2, 2023
Last Update Posted : June 2, 2023
Sponsor:
Information provided by (Responsible Party):
US Oncology Research

Tracking Information
First Submitted Date February 22, 2023
First Posted Date June 2, 2023
Last Update Posted Date June 2, 2023
Actual Study Start Date January 30, 2023
Estimated Primary Completion Date December 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2023)
  • Proportion of Patients Who Receive Biomarker Test Results Prior to Systemic Therapy or Death [ Time Frame: 5 years from date of enrollment into study ]
  • Proportion of Patients Who Receive Single-gene Testing Compared to Those that Receive Comprehensive Biomarker Testing [ Time Frame: 5 years from date of enrollment into study ]
    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.
  • For Patients without Biomarker Test Results, List Reasons for Not Conducting Testing [ Time Frame: 5 years from date of enrollment into study ]
    1. Clinical deterioration, clinical crisis
    2. Tissue: obtaining sample, tissue retrieval
    3. Assay failure for 1 or more biomarkers: Quantity Not Sufficient (QNS), Quality Assurance (QA) fail, test failure
    4. Patient/provider attitudes & perceptions
    5. Provider knowledge about testing options
    6. Patient knowledge about biomarker testing
    7. Payor Coverage: prior authorization denial, payor refusal
    8. Financial barriers: uncovered costs, reimbursement
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 30, 2023)
  • Proportion of patients placed on biomarker-directed first treatment regimen vs those who were not [ Time Frame: 5 years from date of enrollment into study ]
  • 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). [ Time Frame: 5 years from date of enrollment into study ]
  • For Patients who Receive Comprehensive Biomarker Testing, list Types of Test Ordered [ Time Frame: 5 years from date of enrollment into study ]
  • For Patients without Biomarker-Directed First Treatment Regimen, Catalog Reasons for Not Prescribing Biomarker-Targeted Therapy [ Time Frame: 5 years from date of enrollment into study ]
    For patients who have received biomarker test results with at least one actionable mutation, catalog the reason for not prescribing biomarker-targeted therapy.
    1. Lack of availability or delays in obtaining targeted therapy
    2. Misinterpretation of test results
    3. Clinical contraindications (allergies, end organ dysfunction, active autoimmune disease, etc.)
    4. Patient/provider attitudes and perceptions
    5. Financial barriers / Uncovered costs
    6. Patient performance status
  • For Patients who Receive Comprehensive Biomarker Testing, list Types of Resulting Treatment Regimen Assigned [ Time Frame: 5 years from date of enrollment into study ]
  • Characteristics of Cancer Care Practices: Number of Geographic Clinical Locations Per Practice [ Time Frame: 5 years from date of enrollment into study ]
  • Characteristics of Cancer Care Practices: Rural Setting vs Urban Setting at each Practice [ Time Frame: 5 years from date of enrollment into study ]
  • Characteristics of Cancer Care Practices: Number of Staff per Practice [ Time Frame: 5 years from date of enrollment into study ]
  • Characteristics of Cancer Care Practices: Patient Volume per Practice [ Time Frame: 5 years from date of enrollment into study ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MYLUNG Consortium Part 3: Observational Study
Official Title Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Longitudinal Prospective RWE Study (MYLUNG Consortium Part 3: Observational Study)
Brief 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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Carcinoma, Non-Small-Cell Lung
Intervention Not Provided
Study Groups/Cohorts Non-small Cell Lung Cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 30, 2023)
7500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2030
Estimated Primary Completion Date December 2030   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Andrea Glidden, BSN, OCN 630-728-5493 andrea.glidden@mckesson.com
Contact: Taqi Mohammad 281-863-6439 taqi.mohammad@mckesson.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05885698
Other Study ID Numbers 22285
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party US Oncology Research
Original Responsible Party Same as current
Current Study Sponsor US Oncology Research
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Makenzi C. Evangelist, MD New York Oncology Hematology
Principal Investigator: Patrick J. Ward, MD Oncology Hematology Care Clinical Trials, LLC
PRS Account US Oncology Research
Verification Date May 2023