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

 1. ≥19 years of age

 2. 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)

 3. Pathologic confirmation of malignancy prior to initiation of first systemic therapy

 4. Patient agrees to the submission of archival biospecimen sample(s) (collected up to two
 years prior) for analysis

 5. Availability of key variables at the time of screening (e.g. stage, demographics)

 6. Have been fully informed and are able to provide written consent for longitudinal
 follow-up and agree to be accessible by phone

 7. 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:

 1. Pre-specified enrollment caps have been met (Figure 1)

 2. Suspected recurrent or subsequently metastatic disease that is not biopsy confirmed
 prior to receipt of initial systemic therapy
Inclusion Criteria:

 1. ≥19 years of age

 2. 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:

 1. Incident metastatic disease (stage IV) undergoing palliative therapy

 2. Non-metastatic disease undergoing adjuvant, neoadjuvant, or concurrent
 chemoradiation with either curative or palliative intent

 3. Recurrent or subsequently metastatic disease (any stage)

 3. Pathologic confirmation of malignancy prior to initiation of first systemic therapy

 4. Submission of archival biospecimen sample(s) (collected up to two years prior) for
 analysis

 5. Availability of key variables at the time of screening (e.g. stage, demographics)

 6. Have been fully informed and are able to provide written consent for longitudinal
 follow-up and agree to be accessible by phone

 7. Patients may be concurrently enrolled in unblinded clinical trials, but not blinded
 clinical trials in which the treatment being administered is unknown

 Exclusion Criteria:

 1. Pre-specified enrollment caps have been met (Figure 1)

 2. Suspected recurrent or subsequently metastatic disease that is not biopsy confirmed
 prior to receipt of initial systemic therapy