Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT03156868
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2017-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Soluble Mediators,Cytokines and FACs as Prognostic Factors in Advanced Non-squamous Lung Carcinoma
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Soluble mediators analyzed (cytokines, FACs)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2017-05-12', 'studyFirstSubmitQcDate': '2017-05-15', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Soluble mediators in relation to progression free survival', 'timeFrame': 'At time of progression, an average of 1 year', 'description': 'to correlate soluble mediators at progression time'}], 'secondaryOutcomes': [{'measure': 'Soluble mediators in relation to response rate', 'timeFrame': 'at time of first response, an average of 3 months', 'description': 'the soluble mediators will be measured in the blood sample at time of first response'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gecp.org', 'label': 'Web page of the sponsor where users can find more information about Fundación GECP studies'}]}, 'descriptionModule': {'briefSummary': 'Recent studies have shown that the assessment of a set of cytokines and / or circulating angiogenic factors (FACs) could be used to identify prognostic factors predictive of efficacy and / or potential mechanisms of resistance to antiangiogenic agents', 'detailedDescription': 'Current management of patients with locally advanced or metastatic NSCLC, with no susceptible molecular alterations (EGFR mutation, ALK translocation, ROS1 fusion), includes combinations based on platinum in the first line of treatment, while in the second Line, there are three possibilities in monotherapy: docetaxel, erlotinib and pemetrexed. Pemetrexed is exclusively indicated for patients with a NSCLC of non-squamous histology. Although all of them have been shown to increase progression-free survival (PFS) and overall survival (OS), the median time to progression is maintained at 3 months, and the median overall survival at 8-9 months.\n\nRecently, other therapeutic options have been incorporated in the context of the second line. Firstly, two antiangiogenic drugs: nintedanib and ramucirumab. The combination of nintedanib or ramucirumab with docetaxel in the second line of treatment has been shown to provide a significant increase in SLP and SG compared to docetaxel (9,11). One of the criticisms of the results of these two trials, common to all antiangiogenic treatments, is the lack of predictive factors that help us to better select the patients who would benefit from such treatment, as well as a better rationalization of Economic costs. On the other hand, recent data from new strategies based on immunotherapies in lung cancer indicate that nivolumab, a PD-1 antibody (Programmed cell death-1), has shown benefit in terms of survival versus docetaxel monotherapy both in Histology as squamous adenocarcinoma after failure to a platinum-based prior line.\n\nBased on the above, the objective of this project is to analyze a panel of soluble mediators by means of multiparametric immunoassay techniques in samples of peripheral blood (at baseline, during treatment, and progression of the disease) obtained from patients With advanced lung adenocarcinoma, without molecular alterations treatable with anti-target drugs, that have progressed to a first line of chemotherapy, irrespective of whether they have received treatment with immunotherapies, and that they will be treated in the second line with chemotherapy (docetaxel) In combination or not with an antiangiogenic. It is a question of analyzing markers or panels of them with a prognostic / predictive meaning, as well as those that could be related to mechanisms of resistance to the administered treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced non-squamous lung carcinoma without molecular alterations susceptible to be treated with specific inhibitors (EGFR mutation, ALK translocation, ROS1 fusion) that have progressed to the first line of chemotherapy and are subsidiary to a second treatment line.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged ≥ 18 years\n2. Histological and / or cytological confirmation of non-squamous pulmonary carcinoma, stage IIIB / IV or recurrent\n3. Failure to a first line of chemotherapy for advanced or recurrent disease. Patients who have received 2 treatment lines will also be included and this will be the 3 rd line provided that during one of the previous lines they have received immunotherapy or antidandial therapies (in patients with a wild type or unknown mutational status).\n4. ECOG 0 or 1\n5. Life expectancy greater than 12 weeks.\n6. Written informed consent of the patient in accordance with current regulations\n\nExclusion Criteria:\n\n1. Receive more than one line of chemotherapy treatment for advanced disease\n2. Hepatic function (one or more of the following values would exclude the patient): a. Total bilirubin outside the limits of normality; B. For patients without hepatic metastasis: ALT or AST\\> 1.5 times ULN; C. For patients with hepatic metastases: total bilirubin outside the limits of normality, ALT or AST\\> 2.5 times the ULN.\n3. Hemogram (one or more of the following values would exclude the patient): a. Absolute neutrophil count \\<1,500 / mm3; B. Platelets \\<100,000 / mm 3; C. Hemoglobin \\<9.0 g / dl.\n4. Situations such as the following: a. Active serious infections, especially if they require antimicrobial or systemic antibiotic treatment, or active or chronic infection with hepatitis C or B virus; B. Severe disease or non-oncological concomitant disease such as neurological, psychiatric or infectious disease or active ulcers (digestive tract, skin) or relevant analytical abnormality; C. Patients who are sexually active and do not want to use a medically acceptable method of contraception during the study and for at least 3 months after the completion of active treatment; D. Psychological, family, sociological or geographical factors; and. Alcoholism or current drug addiction; F. Preexisting ascites and / or clinically significant pleural effusion; G. Decompensated diabetes mellitus or other contraindication to treatment with corticosteroids at high doses\n5. Pregnancy or breastfeeding; The women must have obtained a negative result in a pregnancy test before starting the treatment'}, 'identificationModule': {'nctId': 'NCT03156868', 'briefTitle': 'Analysis of Soluble Mediators,Cytokines and FACs as Prognostic Factors in Advanced Non-squamous Lung Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Spanish Lung Cancer Group'}, 'officialTitle': 'Analysis of Soluble Mediators, Cytokines, and Circulating Angiogenic Factors (FACs) as Potential Predictors / Prognostic Factors in Antiangiogenic Therapy Following Failure of First-line Chemotherapy in Advanced Non-squamous Lung Carcinoma', 'orgStudyIdInfo': {'id': 'GECP 16/02_SELINA'}}, 'contactsLocationsModule': {'locations': [{'zip': '03202', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital de Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '03186', 'city': 'Torrevieja', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital de Torrevieja', 'geoPoint': {'lat': 37.97872, 'lon': -0.68222}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'ICO-Badalona', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08190', 'city': 'Sant Cugat del Vallès', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital General de Catalunya', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}, {'zip': '08220', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Sanitari de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '35016', 'city': 'Las Palmas de Gran Canaria', 'state': 'Gran Canaria', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario Insular de Gran Canaria', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '28911', 'city': 'Leganés', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Severo Ochoa', 'geoPoint': {'lat': 40.32718, 'lon': -3.7635}}, {'zip': '07198', 'city': 'Palma de Mallorca', 'state': 'Mallorca', 'country': 'Spain', 'facility': 'Hospital Son Llàtzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '29603', 'city': 'Marbella', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Costa del Sol', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Clínica Universitaria de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '46600', 'city': 'Alzira', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario de la Ribera', 'geoPoint': {'lat': 39.15, 'lon': -0.43333}}, {'zip': '03010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'H.G.U. Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08028', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Quirón Dexeus', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de La Santa Creu I Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '12002', 'city': 'Castelló', 'country': 'Spain', 'facility': 'H. Provincial de Castellón', 'geoPoint': {'lat': 41.01149, 'lon': 0.84856}}, {'zip': '23007', 'city': 'Jaén', 'country': 'Spain', 'facility': 'Hospital de Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '27003', 'city': 'Lugo', 'country': 'Spain', 'facility': 'Hospital Lucus Agustí', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '28035', 'city': 'Madrid', 'country': 'Spain', 'facility': 'H.U. Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'H. Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clinico de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '38010', 'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'Hospital Nuestra Señora Candelaria', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '43003', 'city': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Sant Pau i Santa Tecla', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}, {'zip': '46014', 'city': 'Valencia', 'country': 'Spain', 'facility': 'H. General U. de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46017', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Dr. Peset', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46500', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital de Sagunto', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Carlos Camps, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General Universitario de Valencia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spanish Lung Cancer Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}