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

Eligibility Criteria:
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