Clinical trial · Observational
MYLUNG Consortium Study Protocol 2
Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Prospective RWE Study (MYLUNG Consortium: Part 2)
NCT05644808CI-TRIAL-00111892MYLUNGactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Non-small Cell Lung Cancer
Primary outcomes (1)
- measure
- Proportion of Patients Who Do and Do Not Receive Biomarker Test Results Prior to Systemic Therapy or Death
- timeFrame
- 5 years from date of enrollment into study
- description
- i. Comprehensive testing is defined as both PD-L1 testing to guide use of immunotherapies \& testing for all genomic alterations for which we have FDA-approved therapies incl EGFR, ALK, ROS1, BRAF, NTRK, RET, KRAS \& MET ii. Document whether patient receives single gene testing for actionable mutations compared to those who receive comprehensive testing. For patients who start systemic therapy prior to or without biomarker results, we will catalog reasons for not conducting testing incl: 1. Clinical deterioration, clinical crisis 2. Insufficient tissue 3. Barriers to test ordering 1. Tissue: obtaining sample, tissue retrieval 2. Assay failure for 1 or more biomarkers: Quantity Not Sufficient (QNS), QA fail, test failure 3. Patient/provider attitudes \& perceptions 4. Provider knowledge about testing options 5. Patient knowledge about biomarker testing 6. Payor Coverage: prior authorization denial, payor refusal 7. Financial barriers: uncovered costs, reimbursement
Secondary outcomes (3)
- measure
- Proportion of patients placed on biomarker-directed first treatment regimen vs those who were not
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDEvangelist M, Wang B, Butrynski JE, Paschold J, Ward PJ, Waterhouse DM, Jotte RM, Ali K, Richards DA, Konduri K, Melnyk A, Owera RS, Hakimian D, Ghaddar H, Lander EM, Robert NJ, Yori JL, Upadhyay V, Spigel DR, Johnson ML. Biomarker Testing Rates and Patterns in Patients With Metastatic Non-Small Cell Lung Cancer: A Prospective, Observational Study in Community Practices. JCO Precis Oncol. 2026 Apr;10(4):e2500832. doi: 10.1200/PO-25-00832. Epub 2026 Apr 22. PMID 42018966