Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-21 @ 7:29 AM
Study NCT ID:
NCT02777658
Status:
COMPLETED
Last Update Posted:
2021-05-27
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes EGFR Mutation-Positive NSCLC
Sponsor:
Organization:
Raw JSON
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HRQoL are collected every 6 months (plus or minus 1.5 months) up to 36 months', 'description': 'Health related quality of life (HRQoL): Assessment of general cancer-associated and specific lung cancer associated parameters by use of standardized HRQoL questionnaires:\n\n* European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire - Core 30 (EORTC QLQ-C30)\n* 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)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epidermal Growth Factor Receptor (EGFR), non-small cell lung cancer (NSCLC), EGFR T790M, EGFR Mutation-Positive Locally Advanced or Advanced NSCLC'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5160R00005&attachmentIdentifier=8806c923-cd90-4b13-80a5-000a53f41b0d&fileName=D5160R00005_PANORAMA_Redacted.pdf&versionIdentifier=', 'label': 'Redacted CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria - Primary Study Cohort\n\n* Provision of written informed consent (patient consent should be within 6 weeks of disease progression, defined elsewhere as the Index Date)\n* Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)\n* 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\n* Patients who have progressed on or after EGFR-TKI therapy (i.e., gefitinib, erlotinib or afatinib) within the patient selection period\n\nInclusion Criteria - Secondary Study Cohort\n\n* Provision of written informed consent (patient consent should be within 6 weeks of NSCLC diagnosis, defined elsewhere as the Index Date)\n* Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)\n* 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).\n\nExclusion Criteria - Primary and Secondary Study Cohorts\n\n• Enrollment in studies that prohibit any participation in this non-interventional study. These patients will be censored.'}, 'identificationModule': {'nctId': 'NCT02777658', 'acronym': 'PANORAMA', 'briefTitle': 'PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes EGFR Mutation-Positive NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With EGFR Mutation-Positive Locally Advanced or Advanced NSCLC', 'orgStudyIdInfo': {'id': 'D5160R00005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Study Cohort', 'description': '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'}, {'label': 'Secondary Study Cohort', 'description': 'Patients diagnosed with de-novo (wild-type) EGFR T790M mutation-positive (alone or in combination with other mutations) locally advanced or advanced NSCLC'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D5160R00005', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': 'D5160R00005', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': 'D5160R00005', 'city': 'Bad Kreuznach', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.8414, 'lon': 7.86713}}, {'zip': 'D5160R00005', 'city': 'Ballenstedt', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.719, 'lon': 11.23265}}, {'zip': 'D5160R00005', 'city': 'Bautzen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.18035, 'lon': 14.43494}}, {'zip': 'D5160R00005', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D5160R00005', 'city': 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For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', '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.', 'accessCriteria': '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. 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