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Trial record 1 of 340 for:    PANORAMA
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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 : Active, not recruiting
First Posted : May 19, 2016
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
iOMEDICO AG, Freiburg, Germany
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease
Carcinoma, Non-Small-Cell Lung

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Study Type : Observational [Patient Registry]
Actual Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With EGFR Mutation-Positive Locally Advanced or Advanced NSCLC
Actual Study Start Date : May 26, 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Group/Cohort
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



Primary Outcome Measures :
  1. 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;


  2. 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;



Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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 ]
  5. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777658


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Sponsors and Collaborators
AstraZeneca
iOMEDICO AG, Freiburg, Germany

Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02777658     History of Changes
Other Study ID Numbers: D5160R00005
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Keywords provided by AstraZeneca:
Epidermal Growth Factor Receptor (EGFR), non-small cell lung cancer (NSCLC), EGFR T790M, EGFR Mutation-Positive Locally Advanced or Advanced NSCLC
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases