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Completed

NCT Number: NCT02777658

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aschaffenburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • iOMEDICO AG, Freiburg, Germany

Registry information

Official study title

PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With EGFR Mutation-Positive Locally Advanced or Advanced NSCLC

Acronym: PANORAMA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 19, 2016
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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