MYLUNG Consortium Part 3: Observational Study (MYLUNG)
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| ClinicalTrials.gov Identifier: NCT05885698 |
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Recruitment Status :
Recruiting
First Posted : June 2, 2023
Last Update Posted : June 2, 2023
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| Condition or disease |
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| Carcinoma, Non-Small-Cell Lung |
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] |
| Estimated Enrollment : | 7500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Longitudinal Prospective RWE Study (MYLUNG Consortium Part 3: Observational Study) |
| Actual Study Start Date : | January 30, 2023 |
| Estimated Primary Completion Date : | December 2030 |
| Estimated Study Completion Date : | December 2030 |
| Group/Cohort |
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| Non-small Cell Lung Cancer |
- 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 ]
- 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
- 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.
- 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
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05885698
| Contact: Andrea Glidden, BSN, OCN | 630-728-5493 | andrea.glidden@mckesson.com | |
| Contact: Taqi Mohammad | 281-863-6439 | taqi.mohammad@mckesson.com |
Show 17 study locations
| Principal Investigator: | Makenzi C. Evangelist, MD | New York Oncology Hematology | |
| Principal Investigator: | Patrick J. Ward, MD | Oncology Hematology Care Clinical Trials, LLC |
| Responsible Party: | US Oncology Research |
| ClinicalTrials.gov Identifier: | NCT05885698 |
| Other Study ID Numbers: |
22285 |
| First Posted: | June 2, 2023 Key Record Dates |
| Last Update Posted: | June 2, 2023 |
| Last Verified: | May 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |
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Carcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |