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PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes EGFR Mutation-Positive NSCLC (PANORAMA)

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ClinicalTrials.gov Identifier: NCT02777658
Recruitment Status : Completed
First Posted : May 19, 2016
Last Update Posted : June 26, 2020
Sponsor:
Collaborator:
iOMEDICO AG, Freiburg, Germany
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date May 17, 2016
First Posted Date May 19, 2016
Last Update Posted Date June 26, 2020
Actual Study Start Date May 26, 2016
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2016)
  • To evaluate molecular testing patterns among patients with EGFR mutation-positive locally advanced or advanced NSCLC [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
    Molecular testing patterns including: Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients in the primary study cohort (applicable to patients in the primary study cohort); Change in testing rates over time - testing rate over time will be described; Molecular testing details including sample type, method of biopsy, testing turnaround time, test type, reason for testing, testing laboratory type, reason for not performing a test; Molecular testing results including mutation status and type, test outcome, histologic/phenotypic transformation;
  • To assess treatment patterns and associated clinical outcomes among patients with EGFR mutation-positive locally advanced or advanced NSCLC [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
    Treatment patterns and associated clinical outcomes including: Overall survival measured from: date of initial diagnosis to date of death from any cause (for primary and secondary cohorts), date of progression to date of death from any cause (for primary cohort only); Time to initiation of new therapy defined as the time from start date of current therapy to start date of subsequent therapy; Treatment(s) received post diagnosis and post progression including chemotherapy, radiation, surgery, targeted therapy, immunotherapy; Treatment sequence patterns, line(s) of therapy, treatment regimen(s), treatment duration, number of cycles;
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 17, 2016)
  • To assess health care utilization patterns [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
    Health care utilization patterns will be presented by the following care settings: hospitalization and length of stay, emergency room and physician office visits
  • To assess treatment related complications [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
    Assessment of treatment related complications observed with chemotherapy and targeted therapies among patients with NSCLC.
  • To assess biopsy related complications [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
    Assessment of biopsy related complications for each documented biopsy procedure
  • To document rate of central nervous system (CNS) metastases [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
  • Assessment of health-related quality of life (HRQoL) [ Time Frame: Date of first visit to last visit. HRQoL are collected every 6 months (plus or minus 1.5 months) up to 36 months ]
    Health related quality of life (HRQoL): Assessment of general cancer-associated and specific lung cancer associated parameters by use of standardized HRQoL questionnaires:
    • European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire - Core 30 (EORTC QLQ-C30)
    • European Organisation For Research And Treatment Of Cancer Quality Of Life Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13) (adminstered to patients included in primary study cohort)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes EGFR Mutation-Positive NSCLC
Official Title PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With EGFR Mutation-Positive Locally Advanced or Advanced NSCLC
Brief Summary The objectives of this study are to assess molecular testing, treatment patterns, and associated outcomes among patients with EGFR (Epidermal Growth Factor Receptor) mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (EGFR-Tyrosine Kinase Inhibitor) therapy post availability of a third-generation TKI (primary study cohort). Additionally, molecular testing and treatment patterns will be assessed among a secondary cohort of patients which will include patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 36 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 800 patients across both cohorts - 700 patients primary cohort and 100 patients secondary cohort. Patients will be recruited from approximately 100 participating sites in Germany (70 hospitals and 30 outpatient practices).
Condition Carcinoma, Non-Small-Cell Lung
Intervention Not Provided
Study Groups/Cohorts
  • Primary Study Cohort
    Patients with prior confirmed EGFR mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (Epidermal Growth Factor Receptor - Tyrosine Kinase Inhibitor) therapy
  • Secondary Study Cohort
    Patients diagnosed with de-novo (wild-type) EGFR T790M mutation-positive (alone or in combination with other mutations) locally advanced or advanced NSCLC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 23, 2019)
165
Original Estimated Enrollment
 (submitted: May 17, 2016)
800
Actual Study Completion Date May 31, 2020
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria - Primary Study Cohort

  • Provision of written informed consent (patient consent should be within 6 weeks of disease progression, defined elsewhere as the Index Date)
  • Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
  • Patients with prior confirmed EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC - Patients who developed resistance to an EGFR-TKI due to any other phenotypic/histologic transformations (e.g., small-cell lung cancer, EMT) or other mutations (e.g., HER2, MET amplifications) at the index-date will be eligible for participation in this study as long as they have prior confirmed diagnosis of EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC
  • Patients who have progressed on or after EGFR-TKI therapy (i.e., gefitinib, erlotinib or afatinib) within the patient selection period

Inclusion Criteria - Secondary Study Cohort

  • Provision of written informed consent (patient consent should be within 6 weeks of NSCLC diagnosis, defined elsewhere as the Index Date)
  • Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
  • Patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC during the patient selection period. The de-novo T790M mutation can be alone or in combination with other mutations (e.g., L858R and T790M).

Exclusion Criteria - Primary and Secondary Study Cohorts

• Enrollment in studies that prohibit any participation in this non-interventional study. These patients will be censored.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02777658
Other Study ID Numbers D5160R00005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators iOMEDICO AG, Freiburg, Germany
Investigators Not Provided
PRS Account AstraZeneca
Verification Date June 2020