Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 1:54 AM
Study NCT ID:
NCT01067794
Status:
COMPLETED
Last Update Posted:
2012-08-24
First Post:
2010-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy in Treating Patients With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1610}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-23', 'studyFirstSubmitDate': '2010-02-01', 'studyFirstSubmitQcDate': '2010-02-10', 'lastUpdatePostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Treatment start to death from any cause (follow-up assessments until death or until end of study, up to 18 months from Last Patient Entered Treatment)'}], 'secondaryOutcomes': [{'measure': 'One-year survival rate', 'timeFrame': '12 months'}, {'measure': 'Progression-free survival', 'timeFrame': 'Treatment start to progression or death (follow-up assessments until death or until end of study, up to 18 months from Last Patient Entered Treatment)'}, {'measure': 'Best tumor response', 'timeFrame': 'Treatment start to progression or treatment end'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metastatic', 'Advanced', 'Stage IIIB-IV', 'daily', 'hospital', 'practice', 'setting'], 'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '23040326', 'type': 'DERIVED', 'citation': 'Schnabel PA, Smit E, Carpeno Jde C, Lesniewski-Kmak K, Aerts J, Kraaij K, Visseren-Grul C, Dyachkova Y, Taipale K, Girvan A, Moro-Sibilot D. Influence of histology and biomarkers on first-line treatment of advanced non-small cell lung cancer in routine care setting: baseline results of an observational study (FRAME). Lung Cancer. 2012 Dec;78(3):263-9. doi: 10.1016/j.lungcan.2012.09.001. Epub 2012 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'This observational study was planned, with the primary objective to observe patient survival following first-line treatment of patients of Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) with different platinum-based doublets under routine disease management conditions. Further secondary objectives of this study are to provide insights to what extent histologic subtyping and the use of additional prognostic or predictive biomarkers are currently considered for differential therapeutic decisions under routine conditions. All of these data are critical to evaluate the factors for differential therapeutic decisions and their effect on patient outcomes in a real life setting, and they can only be obtained through observational research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients (\\> 18 yrs.) initiating first-line treatment for advanced or metastatic (stage IIIB-IV) NSCLC with any platinum-based doublet chemotherapy, with or without additional targeted agents treated in public hospitals, private hospitals or by office based physicians', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological diagnosis of non-small cell lung cancer (NSCLC) stage IIIB-IV\n* Initiation of first-line treatment for advanced NSCLC with any platinum-based doublet chemotherapy, with or without additional targeted agents\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Participating simultaneously in a study including administration of any investigational drug or procedure at entry into this study'}, 'identificationModule': {'nctId': 'NCT01067794', 'acronym': 'FRAME', 'briefTitle': 'Chemotherapy in Treating Patients With Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'First-line Treatment of Non-Small Cell Lung Cancer Under Routine Conditions: Observational Study on Overall Survival', 'orgStudyIdInfo': {'id': '13095'}, 'secondaryIdInfos': [{'id': 'H3E-EW-B012', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'pemetrexed + platinum', 'description': 'Patients with pemetrexed + platinum doublet, with or without additional targeted agents', 'interventionNames': ['Drug: Any platinum-based doublet chemotherapy']}, {'label': 'gemcitabine + platinum', 'description': 'Patients with gemcitabine + platinum doublet, with or without additional targeted agents', 'interventionNames': ['Drug: Any platinum-based doublet chemotherapy']}, {'label': 'taxanes + platinum', 'description': 'Patients with taxanes + platinum doublet, with or without additional targeted agents', 'interventionNames': ['Drug: Any platinum-based doublet chemotherapy']}, {'label': 'vinorelbine + platinum', 'description': 'Patients with vinorelbine + platinum doublet, with or without additional targeted agents', 'interventionNames': ['Drug: Any platinum-based doublet chemotherapy']}, {'label': 'others + platinum', 'description': 'Patients with other platinum-based doublet, with or without additional targeted agents', 'interventionNames': ['Drug: Any platinum-based doublet chemotherapy']}], 'interventions': [{'name': 'Any platinum-based doublet chemotherapy', 'type': 'DRUG', 'description': 'Dosage, dosage form, frequency and duration according to daily hospital practice', 'armGroupLabels': ['gemcitabine + platinum', 'others + platinum', 'pemetrexed + platinum', 'taxanes + platinum', 'vinorelbine + platinum']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}