Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now

Study Overview
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Brief Summary
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REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables. The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date. The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria.

Detailed Description
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REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables. The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date. The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria. Study Patient Selection Criteria Patients are eligible to be included in the study if they meet all of the following criteria: ≥19 years of age Patients with a primary diagnosis of NSCLC within the past 5 years who are eligible for their first systemic therapy based on disease characteristics. Systemic therapy may include any cytotoxic, targeted, immune-based, or otherwise non-local treatment modality. Specific allowed settings include the following: Incident metastatic disease (stage IV) undergoing palliative therapy Non-metastatic disease undergoing adjuvant, neoadjuvant, or concurrent chemoradiation with either curative or palliative intent Recurrent or subsequently metastatic disease (any stage) Pathologic confirmation of malignancy prior to initiation of first systemic therapy Patient agrees to the submission of archival biospecimen sample(s) (collected up to two years prior) for analysis Availability of key variables at the time of screening (e.g. stage, demographics) Have been fully informed and are able to provide written consent for longitudinal follow-up and agree to be accessible by phone Patients may be concurrently enrolled in unblinded clinical trials, but not blinded clinical trials in which the treatment being administered is unknown Patients are excluded if they meet any of the following criteria: Pre-specified enrollment caps have been met (Figure 1) Suspected recurrent or subsequently metastatic disease that is not biopsy confirmed prior to receipt of initial systemic therapy

Official Title
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Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now

Conditions
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Non-Small-Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥19 years of age Patients with a primary diagnosis of NSCLC within the past 5 years who are eligible for their first systemic therapy based on disease characteristics. Systemic therapy may include any cytotoxic, targeted, immune-based, or otherwise non-local treatment modality. Specific allowed settings include the following: Incident metastatic disease (stage IV) undergoing palliative therapy Non-metastatic disease undergoing adjuvant, neoadjuvant, or concurrent chemoradiation with either curative or palliative intent Recurrent or subsequently metastatic disease (any stage) Pathologic confirmation of malignancy prior to initiation of first systemic therapy Submission of archival biospecimen sample(s) (collected up to two years prior) for analysis Availability of key variables at the time of screening (e.g. stage, demographics) Have been fully informed and are able to provide written consent for longitudinal follow-up and agree to be accessible by phone Patients may be concurrently enrolled in unblinded clinical trials, but not blinded clinical trials in which the treatment being administered is unknown Exclusion Criteria: Pre-specified enrollment caps have been met (Figure 1) Suspected recurrent or subsequently metastatic disease that is not biopsy confirmed prior to receipt of initial systemic therapy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of treatment decisions using molecular testing and results, provider decisions and patient preferences. | Characterize current practice patterns for the care of patients with NSCLC, with a special emphasis on pharmacotherapy (i.e. chemotherapy, targeted agents, and immunotherapy) and patients with EGFR mutated disease. These data will include treatment, molecular test administration and results, provider decisions and patient preferences, and explore the determinants of each. | Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months. | 
| Assessment of progression-free survival | Compare progression-free survival, overall survival, and duration of response associated with targeted therapies, immune checkpoint inhibitors, and cytotoxic chemotherapy in NSCLC and EGFR mutated disease. | Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months. | 
| Assessment of overall survival | Compare progression-free survival, overall survival, and duration of response associated with targeted therapies, immune checkpoint inhibitors, and cytotoxic chemotherapy in NSCLC and EGFR mutated disease. | Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months. | 
| Assessment of treatments. | Compare of progression-free survival, overall survival, and duration of response associated with targeted therapies, immune checkpoint inhibitors, and cytotoxic chemotherapy in NSCLC and EGFR mutated disease. | Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of billing claims data. | Assessments will be aggregated to quantify total, treatment-related, and toxicity-related health care resource utilization and associated financial burden at the population level (not at the individual patient level) using a three-pronged approach including 1) costs extracted from site billing claims, 2) payments obtained from Medicare claims and 3) both objective and subjective measures of patient financial burden to be collected alongside PROs. | Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months. | 
| Assessment of patient demographics, smoking history and disease characteristics | Characterize the current landscape of actionable mutations in the general clinical population and identify additional factors such as demographics, smoking history, and disease characteristics that predict the presence of actionable mutations as well as the development of T790M mutations in patients with EGFR mutated disease at initial presentation. | Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months. | 
| Assessment of patient hospitalizations. | Assess quality of life (QOL) associated with various treatment regimens and the association of severe complications (i.e. hospitalizations, emergency room visits) with treatment. | Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months. | 
| Assessment of targeted, immune, and cytotoxic therapies | Assess patient reported outcomes associated with commonly used targeted, immune, and cytotoxic therapies and additionally measures of patient reported objective and subjective financial burden as a result of their cancer treatment. | Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months. | 
| Assessment of financial burden related to treatment | Assess patient reported outcomes associated with commonly used targeted, immune, and cytotoxic therapies and additionally measures of patient reported objective and subjective financial burden as a result of their cancer treatment. | Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months. | 
| Assessment of EGFR mutation status. | Characterize and describe the NSCLC patient population as a whole and by EGFR mutation status, with emphasis on demographics and comorbidities. | Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months. | 
| Assessment of molecular markers using tissue specimens. | Bank archived tissue specimens for future assessment of molecular markers identified in this or other relevant studies. | Time from first patient enrolled up to study completion, approximately 3 years. | 
| Assessment of molecular markers using blood specimens | Analyze other specimens (eg blood) for future assessment of molecular markers. | Time from first patient enrolled up to study completion, approximately 3 years. | 
| Assessment of costs extracted from site billing claims | Assessments will be aggregated to quantify total, treatment-related, and toxicity-related health care resource utilization and associated financial burden at the population level (not at the individual patient level) using a three-pronged approach including 1) costs extracted from site billing claims, 2) payments obtained from Medicare claims and 3) both objective and subjective measures of patient financial burden to be collected alongside PROs. | Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months. | 
| Assessment of patient financial burden using the Patient reported objective and subjective measures of financial toxicity patient questionnaire | Assessments will be aggregated to quantify total, treatment-related, and toxicity-related health care resource utilization and associated financial burden at the population level (not at the individual patient level) using a three-pronged approach including 1) costs extracted from site billing claims, 2) payments obtained from Medicare claims and 3) both objective and subjective measures of patient financial burden to be collected alongside PROs. | Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months. |