Brief Summary
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.
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.
Brief Title
Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now
Detailed Description
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
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
Categories
Completion Date
Completion Date Type
Actual
Conditions
Non-Small-Cell Lung Cancer
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
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
Inclusion 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
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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT02835599
Org Class
Industry
Org Full Name
AstraZeneca
Org Study Id
D133FR00110
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now
Primary Outcomes
Outcome Description
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.
Outcome Measure
Assessment of treatment decisions using molecular testing and results, provider decisions and patient preferences.
Outcome Time Frame
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Outcome Description
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.
Outcome Measure
Assessment of progression-free survival
Outcome Time Frame
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Outcome Description
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.
Outcome Measure
Assessment of overall survival
Outcome Time Frame
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Outcome Description
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.
Outcome Measure
Assessment of treatments.
Outcome Time Frame
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Outcome Measure
Assessment of billing claims data.
Outcome Description
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.
Outcome Time Frame
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Outcome Measure
Assessment of patient demographics, smoking history and disease characteristics
Outcome Description
Assess quality of life (QOL) associated with various treatment regimens and the association of severe complications (i.e. hospitalizations, emergency room visits) with treatment.
Outcome Time Frame
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Outcome Measure
Assessment of patient hospitalizations.
Outcome Description
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.
Outcome Time Frame
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Outcome Measure
Assessment of targeted, immune, and cytotoxic therapies
Outcome Description
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.
Outcome Time Frame
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Outcome Measure
Assessment of financial burden related to treatment
Outcome Description
Characterize and describe the NSCLC patient population as a whole and by EGFR mutation status, with emphasis on demographics and comorbidities.
Outcome Time Frame
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Outcome Measure
Assessment of EGFR mutation status.
Outcome Description
Bank archived tissue specimens for future assessment of molecular markers identified in this or other relevant studies.
Outcome Time Frame
Time from first patient enrolled up to study completion, approximately 3 years.
Outcome Measure
Assessment of molecular markers using tissue specimens.
Outcome Description
Analyze other specimens (eg blood) for future assessment of molecular markers.
Outcome Time Frame
Time from first patient enrolled up to study completion, approximately 3 years.
Outcome Measure
Assessment of molecular markers using blood specimens
Outcome Description
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.
Outcome Time Frame
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Outcome Measure
Assessment of costs extracted from site billing claims
Outcome Description
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.
Outcome Time Frame
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Outcome Measure
Assessment of patient financial burden using the Patient reported objective and subjective measures of financial toxicity patient questionnaire
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study 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.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Balazs Halmos
Investigator Email
bahalmos@montefiore.org
Investigator Phone