Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-01-01 @ 12:57 AM
Study NCT ID:
NCT04742192
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2021-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional, Prospective Study to Determine Prevalence of EGFR Mutations in Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 601}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-02-04', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of patients with a tumour PD-L1 IHC test result', 'timeFrame': '3 Month', 'description': 'Proportion of patients with PD-L1 positivity at various cut-points (\\<1%, ≥1%, ≥50%) grouped according to:\n\n* EGFRm\n* EGFR wild type'}], 'primaryOutcomes': [{'measure': 'Overall proportion of patients with EGFRm', 'timeFrame': '3 month', 'description': 'Prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC followed by Proportion of EGFRm by the following subgroup:\n\no Histology (adenocarcinoma, bronchiole-alveolar, large cell carcinoma, mixed, other, unknown)'}, {'measure': 'Proportion of EGFRm in Pathologic Stage', 'timeFrame': '3 Month', 'description': 'Prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC followed by Proportion of EGFRm by the following subgroup:\n\no Pathologic stage (IA, IB, IIA, IIB, IIIA, IIIB with lymph node metastasis status \\[N0, N1, and N2\\])b'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with the EGFRm types', 'timeFrame': '3 Month', 'description': 'Proportion of patients with the following EGFRm types:\n\n* Exon19 deletions\n* Exon21 L858R\n* Exon20 T790M\n* Others (compound mutationsb, uncommon mutations \\[including G719X, L861Q, S768I, and 20 insertions\\])'}, {'measure': 'Proportion of patients who were prescribed modalities', 'timeFrame': '3 Month', 'description': 'Proportion of patients who were prescribed these modalities:\n\n* Only surgical resection\n* Surgical resection and radiotherapy\n* Surgical resection and systemic therapy (neoadjuvant and/or adjuvant)\n* Surgical resection, radiotherapy and systemic therapy (neoadjuvant and/or adjuvant)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '39772802', 'type': 'DERIVED', 'citation': 'Batra U, Prabhash K, Noronha V, Deshpande R, Khurana S, Bhat GM, Mistry R, Agarwala V, Rajpurohit S, Poladia B, Sharma M, Banday SZ. Prevalence of EGFR Mutations in Patients With Resected Stage I to III Nonsquamous Non-Small Cell Lung Cancer: Results of India Cohort. JCO Glob Oncol. 2025 Jan;11:e2400353. doi: 10.1200/GO-24-00353. Epub 2025 Jan 7.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5161R00028&attachmentIdentifier=f8a9618e-fac2-4cf6-98db-e8ee04f49f59&fileName=EARLY-EGFR_Clinical_Study_Report_(CSR)_Synopsis_F.pdf&versionIdentifier=', 'label': 'Redacted CSR synopsis'}]}, 'descriptionModule': {'briefSummary': 'This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study.\n\nThe main objective of this study is to determine the prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB) non-squamous NSCLC as there are limited data on its prevalence in this patient population.', 'detailedDescription': "This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study. Eligible patients should have availability of formalin-fixed paraffin-embedded (FFPE) specimen(s) to be primarily tested for EGFRm at validated local laboratories or a central laboratory. The informed consent will be obtained from the patients during their routine clinical care visit before data are collected from the medical records. The data on socio-demographics, tumour staging, histology, surgical management, and neoadjuvant therapies will be collected from available medical records at the treating facility by the investigator. If PD-L1 testing is conducted as part of routine clinical care, the available results will be recorded. Patients will be followed prospectively and follow-up will be considered as complete once EGFRm status of the patient's tumour sample is known and any planned adjuvant therapy has been recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients who have stage IA to IIIB NSCLC with non-squamous histology and who have undergone surgical resection of tumour up to 6 weeks prior to enrolment', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult male or female patients ≥18 years old or 'adults' according to age of majority as defined by the local regulations\n* Patient or next of kin/legal representative is willing and able to provide informed consent according to the local regulations, where applicable\n* Patients with stage IA to IIIB (on the basis of pathologic criteria) NSCLC with adenocarcinoma, or mixed histology with an adenocarcinoma component who have undergone surgical resection of the tumour during the preceding 6 weeks\n* Availability of FFPE tissue specimen suitable for EGFRm testing (either the primary diagnostic sample or the surgically resected tumour specimen)\n* Availability of medical records at the participating site detailing the initial diagnosis, staging, and surgical management of NSCLC\n\nExclusion Criteria:\n\nPatients who fulfil any of the following exclusion criteria will not be eligible for the study:\n\n1. Histology of the tumour is considered not to be of primary lung in origin\n2. Histology is pure squamous cell carcinoma, pure small cell carcinoma, or large cell carcinoma origin lacking any immunohistochemistry evidence of adenocarcinoma differentiation -"}, 'identificationModule': {'nctId': 'NCT04742192', 'acronym': 'EARLY-EGFR', 'briefTitle': 'Non-interventional, Prospective Study to Determine Prevalence of EGFR Mutations in Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multicountry, Multicentre, Non-interventional, Prospective Study to Determine the Prevalence of EGFR Mutations in Patients With Early-stage, Surgically Resected, Non-squamous, Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'D5161R00028'}}, 'contactsLocationsModule': {'locations': [{'zip': 'S2002RE', 'city': 'Rosario - Santa Fe', 'state': 'Argentina', 'country': 'Argentina', 'facility': 'Research Site'}, {'zip': '1415', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': 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