Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-07 @ 7:19 AM
Study NCT ID:
NCT01656551
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2012-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MILES-4: Study Comparing Gemcitabine and Pemetrexed, With or Without Cisplatin, in Patients With Nonsquamous 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2012-07-23', 'studyFirstSubmitQcDate': '2012-07-31', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'identification of patient and lesion specific prognostic factors', 'timeFrame': '2 years'}, {'measure': 'identification of patient and lesion specific factors predictive of chemotherapy efficacy', 'timeFrame': '2 years'}], 'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'one year', 'description': 'factorial design with two comparisons: single agent chemotherapy versus chemotherapy plus cisplatin (Arms A+C versus Arms B + D), and gemcitabine versus pemetrexed (Arms A+B versus Arms C+D)'}], 'secondaryOutcomes': [{'measure': 'worst grade toxicity per patient', 'timeFrame': 'evaluated at end of each 3 week cycle of chemotherapy up to 18 weeks', 'description': 'according to Common Toxicity Criteria for Adverse Events v. 4.03'}, {'measure': 'progression free survival', 'timeFrame': '6 months'}, {'measure': 'changes in quality of life', 'timeFrame': 'baseline and up to 18 weeks'}, {'measure': 'objective response', 'timeFrame': 'after 9 and 18 weeks of therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['elderly', 'chemotherapy'], 'conditions': ['Non-small Cell Lung Cancer Metastatic', 'Non-small Cell Lung Cancer Stage IIIB']}, 'referencesModule': {'references': [{'pmid': '30028656', 'type': 'DERIVED', 'citation': 'Gridelli C, Morabito A, Cavanna L, Luciani A, Maione P, Bonanno L, Filipazzi V, Leo S, Cinieri S, Ciardiello F, Burgio MA, Bilancia D, Cortinovis D, Rosetti F, Bianco R, Gebbia V, Artioli F, Bordonaro R, Fregoni V, Mencoboni M, Nelli F, Riccardi F, di Isernia G, Costanzo R, Rocco G, Daniele G, Signoriello S, Piccirillo MC, Gallo C, Perrone F. Cisplatin-Based First-Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer: Joint Analysis of MILES-3 and MILES-4 Phase III Trials. J Clin Oncol. 2018 Sep 1;36(25):2585-2592. doi: 10.1200/JCO.2017.76.8390. Epub 2018 Jul 20.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to test whether the addition of cisplatin to single agent chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with non squamous non small cell lung cancer (NSCLC), and to test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cytologically or histologically confirmed non-small cell lung cancer.\n* Non squamous tumor type (including those with a non-specified tumor type).\n* Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition.\n* Both patients at first diagnosis or those with disease recurrence after former surgery are eligible.\n* At least one target or non-target lesion according to RECIST revised version 1.1.\n* Male or female \\> or = 70 years of age.\n* ECOG PS 0 or 1.\n* Life expectancy \\> 3 months.\n* Neutrophils \\> or = 1500 mm3, platelets \\> or = 100000 mm3, and haemoglobin \\> or = 9 g/dL.\n* Bilirubin level either normal or \\< 1.5 x ULN.\n* AST (SGOT) and ALT (SGPT) \\< or = 2.5 x ULN (\\< or = 5 x ULN if liver metastasis are present).\n* Serum creatinine \\< 1.5 x ULN.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease. Prior surgery and/or localised irradiation is permitted. Prior adjuvant chemotherapy is permitted if it did not contain gemcitabine and pemetrexed and if at least 6 months elapsed from the end of adjuvant chemotherapy.\n* Any unstable systemic disease (including active infections, significant cardiovascular disease or myocardial infarction within the previous year, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medications or render the patient at high risk from treatment complications.\n* Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA).\n* Patients with symptomatic brain metastasis or spinal cord compression that has not yet been treated with surgery and/or radiation; patients with CNS metastases or spinal cord compression previously treated with surgery and/or radiation are eligible if they are asymptomatic and do not require steroids (anti-seizure medications are allowed).\n* Known or suspected hypersensitivity to any of the study drugs'}, 'identificationModule': {'nctId': 'NCT01656551', 'acronym': 'MILES-4', 'briefTitle': 'MILES-4: Study Comparing Gemcitabine and Pemetrexed, With or Without Cisplatin, in Patients With Nonsquamous Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Naples'}, 'officialTitle': 'A Factorial Study Comparing Pemetrexed With Gemcitabine and Testing the Efficacy of the Addition of Cisplatin in Elderly Patients With Non Squamous Advanced, Metastatic or Recurrent NSCLC.', 'orgStudyIdInfo': {'id': 'MILES-4'}, 'secondaryIdInfos': [{'id': '2012-000164-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A: Gemcitabine', 'description': 'Single agent gemcitabine dose 1200 mg/m2 days 1 and 8, every 3 weeks', 'interventionNames': ['Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'B: Gemcitabine + Cisplatin', 'description': 'Gemcitabine dose 1000 mg/m2 days 1 and 8, every 3 weeks', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C: Pemetrexed', 'interventionNames': ['Drug: Pemetrexed']}, {'type': 'EXPERIMENTAL', 'label': 'D: Pemetrexed + Cisplatin', 'interventionNames': ['Drug: Pemetrexed', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Gemcitabine', 'type': 'DRUG', 'armGroupLabels': ['A: Gemcitabine', 'B: Gemcitabine + Cisplatin']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': '500 mg/m2 day 1 every 3 weeks', 'armGroupLabels': ['C: Pemetrexed', 'D: Pemetrexed + Cisplatin']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '60 mg/m2 day 1 every 3 weeks', 'armGroupLabels': ['B: Gemcitabine + Cisplatin', 'D: Pemetrexed + Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alba', 'country': 'Italy', 'facility': 'Ospedale San Lazzaro', 'geoPoint': {'lat': 44.6999, 'lon': 8.0347}}, {'city': 'Ancona', 'country': 'Italy', 'facility': 'Ospedali Riunit Umberto I-Lancisi-Salesi', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Aprilia', 'country': 'Italy', 'facility': 'Oncologia Universitaria degli Studi di Roma', 'geoPoint': {'lat': 41.59452, 'lon': 12.65419}}, {'city': 'Asti', 'country': 'Italy', 'facility': 'Ospedale Cardinal Massaia', 'geoPoint': {'lat': 44.90162, 'lon': 8.20751}}, {'city': 'Avellino', 'country': 'Italy', 'facility': 'S. Giuseppe Moscati', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'city': 'Brindisi', 'country': 'Italy', 'facility': 'Ospedale Senatore Antonio Perrino', 'geoPoint': {'lat': 40.63215, 'lon': 17.93607}}, {'city': 'Cagliari', 'country': 'Italy', 'facility': 'Univeristaria Policlinico Monserrato di Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Campobasso', 'country': 'Italy', 'facility': 'Ospedale A. cardarelli', 'geoPoint': {'lat': 41.55947, 'lon': 14.66737}}, {'city': 'Camposampiero', 'country': 'Italy', 'facility': 'U.L.S.S. 15 Veneto', 'geoPoint': {'lat': 45.56368, 'lon': 11.93534}}, {'city': 'Carpi', 'country': 'Italy', 'facility': 'Ospedale Ramazzini di Carpi', 'geoPoint': {'lat': 44.78237, 'lon': 10.8777}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Garibalda Nesimadi Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Policlinico vittorio Emanuele', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Chioggia', 'country': 'Italy', 'facility': 'Ospedale della Madonna della Navicella', 'geoPoint': {'lat': 45.21857, 'lon': 12.27774}}, {'city': 'Faenza', 'country': 'Italy', 'facility': 'Ospedale Civile di Faenza', 'geoPoint': {'lat': 44.29007, 'lon': 11.87948}}, {'city': 'Frosinone', 'country': 'Italy', 'facility': 'Ospedale Fabrizio Spaziani', 'geoPoint': {'lat': 41.63976, 'lon': 13.34109}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'IRCCS AOU San Martino IST Genova', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Ospedale Villa Scassi', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Lecce', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Vito Fazzi', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'city': 'Legnano', 'country': 'Italy', 'facility': 'Ospedale Civile di Legnano', 'geoPoint': {'lat': 45.59788, 'lon': 8.91506}}, {'city': 'Lugo', 'country': 'Italy', 'facility': 'Ospedale Umberto I', 'geoPoint': {'lat': 44.42137, 'lon': 11.91094}}, {'city': 'Meldola', 'country': 'Italy', 'facility': 'IRCCS-Meldola', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale L. Sacco Polo Universitario', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale S. Paolo', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Mirano', 'country': 'Italy', 'facility': 'U.L.S.S. 13', 'geoPoint': {'lat': 45.49458, 'lon': 12.10775}}, {'city': 'Monza', 'country': 'Italy', 'facility': 'H San Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'A.O.U. 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