Clinical trial NCT02835599: Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now
Official title: Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-Small-Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-07-18
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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

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

Primary outcomes:
measure: Assessment of treatment decisions using molecular testing and results, provider decisions and patient preferences.
timeFrame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
measure: Assessment of progression-free survival
timeFrame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
measure: Assessment of overall survival
timeFrame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
measure: Assessment of treatments.
timeFrame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Secondary outcomes:
measure: Assessment of billing claims data.
timeFrame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
measure: Assessment of patient demographics, smoking history and disease characteristics
timeFrame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
measure: Assessment of patient hospitalizations.
timeFrame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
measure: Assessment of targeted, immune, and cytotoxic therapies
timeFrame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
measure: Assessment of financial burden related to treatment
timeFrame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
measure: Assessment of EGFR mutation status.
timeFrame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
measure: Assessment of molecular markers using tissue specimens.
timeFrame: Time from first patient enrolled up to study completion, approximately 3 years.
measure: Assessment of molecular markers using blood specimens
timeFrame: Time from first patient enrolled up to study completion, approximately 3 years.
measure: Assessment of costs extracted from site billing claims
timeFrame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
measure: Assessment of patient financial burden using the Patient reported objective and subjective measures of financial toxicity patient questionnaire
timeFrame: Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Other outcomes:
measure: Assessment of patient treatments
timeFrame: Time from first patient enrolled up to 3 years.
measure: Evaluate multiple comorbidities and low socioeconomic status
timeFrame: Time from first patient enrolled up to 3 years
measure: Evaluate patients with advanced disease (e.g. multiple metastases, symptomatic disease, weight loss)
timeFrame: Time from first patient enrolled up to 3 years
Locations:
city: Monterey
country: United States
facility: Research Site
state: California
city: Santa Rosa
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Urbana
country: United States
facility: Research Site
state: Illinois
city: Southfield
country: United States
facility: Research Site
state: Michigan
city: Duluth
country: United States
facility: Research Site
state: Minnesota
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: Jackson
country: United States
facility: Research Site
state: Mississippi
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Rock Hill
country: United States
facility: Research Site
state: South Carolina
city: Germantown
country: United States
facility: Research Site
state: Tennessee
city: Newport News
country: United States
facility: Research Site
state: Virginia
city: Tacoma
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Duke Clinical Research Institute
name: Jeffery Crawford, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atrium Health Levine Cancer Institute
name: Edward Kim, MD
role: STUDY_CHAIR
References: