Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-04 @ 5:47 PM
Study NCT ID:
NCT05059951
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy With or Without Immune Checkpoint Inhibitors for 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': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'tissue sample and plasma DNA was obtained with the permission of patients.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-01', 'studyFirstSubmitDate': '2021-09-17', 'studyFirstSubmitQcDate': '2021-09-17', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Time from first subject dose to study completion, or up to 36 month', 'description': 'To assess progression-free survival of patients treated by different treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Time from first subject dose to study completion, or up to 36 months.', 'description': 'To assess overall survival, define as first dose to the death of the subject due to any cause'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Time from first subject dose to study completion, or up to 36 months.', 'description': 'To assess ICI and TKIs overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Time from first subject dose to study completion, or up to 36 month', 'description': 'To assess duration of response for subjects with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator , defined as the time from the first documented CR or PR to disease progression or death'}, {'measure': 'Adverse events (AEs) according to CTCAE 5.0', 'timeFrame': 'From first dose until 28 days after the last dose, up to 24 month', 'description': 'Number of participants with adverse events (AEs) according to CTCAE 5.0'}, {'measure': 'Patient reported outcome', 'timeFrame': 'Time from first subject dose to study completion, or up to 36 months.', 'description': "Patient reported outcomes (PROs): A report that directly reflects a patient's assessment of their own health status."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chemotherapy, Immune Checkpoint Inhibitors'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Although several clinical trials provide evidence for efficacy benefit for Checkpoint Inhibitors plus chemotherapy for lung cancer. However, there was rare evidence for clinical evidence in Hunan province.', 'detailedDescription': 'This prospective study aimed to assess its efficacy and adverse event for Checkpoint Inhibitors with or without chemotherapy in clincial practice. Several cohorts were devided including pathological type, treatment line, treatment regiems, combination strategies. Tissue samples were collected with permission of patients for TME evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥18，Lung Cancer Confirmed by Histopathology\n2. Treated with Chemotherapy with or Without Checkpoint Inhibitors.\n3. ECOG 0 - 1.\n4. Predicted survival ≥ 12 weeks.\n5. Adequate bone marrow hematopoiesis and organ function\n6. Presence of measurable lesions according to RECIST 1.1.\n7. Subjects with stable brain metastases may be included in the study.\n\nExclusion Criteria:\n\nPatients did not match for the Inclusion Criteria.'}, 'identificationModule': {'nctId': 'NCT05059951', 'acronym': 'CREATE', 'briefTitle': 'Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': 'Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer', 'orgStudyIdInfo': {'id': '20210113'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'Extansive Stage Small Cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .', 'interventionNames': ['Drug: Immune checkpoint inhibitor']}, {'label': 'Cohort B', 'description': 'Limit Stage Small Celll Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .', 'interventionNames': ['Drug: Immune checkpoint inhibitor']}, {'label': 'Cohort C', 'description': 'Small Celll Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors.', 'interventionNames': ['Drug: Immune checkpoint inhibitor']}, {'label': 'Cohort D', 'description': 'Metastastic Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.', 'interventionNames': ['Drug: Immune checkpoint inhibitor']}, {'label': 'Cohort E', 'description': 'Metastastic Non-small cell Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors.', 'interventionNames': ['Drug: Immune checkpoint inhibitor']}, {'label': 'Cohort F', 'description': 'Resectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.', 'interventionNames': ['Drug: Immune checkpoint inhibitor']}, {'label': 'Cohort G', 'description': 'Unresectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.', 'interventionNames': ['Drug: Immune checkpoint inhibitor']}, {'label': 'Cohort H', 'description': 'Non-small cell Lung Cancer received neoadjuvent or adjuvent Chemotherapy with or without Checkpoint Inhibitors.', 'interventionNames': ['Drug: Immune checkpoint inhibitor']}, {'label': 'Cohort I', 'description': 'Cohort I, Non-small cell Lung Cancer with EGFR, ALK and ROS1 sensitive mutation who received Chemotherapy with or without Checkpoint Inhibitors.', 'interventionNames': ['Drug: Immune checkpoint inhibitor']}, {'label': 'Cohort J', 'description': 'Non-small cell Lung Cancer with other oncogenic mutation including RET, BRAF etc who received Chemotherapy with or without Checkpoint Inhibitors.', 'interventionNames': ['Drug: Immune checkpoint inhibitor']}, {'label': 'Cohort K', 'description': 'Non-small cell Lung Cancer received Chemotherapy plus bevacizumab with or without Checkpoint Inhibitors.', 'interventionNames': ['Drug: Immune checkpoint inhibitor']}, {'label': 'Cohort L', 'description': 'Non-small cell Lung Cancer who enrolled in clinical trials.', 'interventionNames': ['Drug: Immune checkpoint inhibitor']}], 'interventions': [{'name': 'Immune checkpoint inhibitor', 'type': 'DRUG', 'otherNames': ['Chemotherapy'], 'description': 'Chemotherapy follow the guild line.', 'armGroupLabels': ['Cohort A', 'Cohort B', 'Cohort C', 'Cohort D', 'Cohort E', 'Cohort F', 'Cohort G', 'Cohort H', 'Cohort I', 'Cohort J', 'Cohort K', 'Cohort L']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongchang Zhang, MD', 'role': 'CONTACT', 'email': 'zhangyongchang@csu.edu.cn', 'phone': '+86 731 89762323'}, {'name': 'Nong Yang, MD', 'role': 'CONTACT', 'email': 'yangnong0217@163.com', 'phone': '+86 731 89762321'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Yongchang Zhang, MD', 'role': 'CONTACT', 'email': 'zhangyongchang@csu.edu.cn', 'phone': '+8613873123436', 'phoneExt': '7+861383123436'}, {'name': 'Nong Yang, MD', 'role': 'CONTACT', 'email': 'yangnong0217@163.com', 'phone': '+8613873123436', 'phoneExt': '+8613873123436'}], 'overallOfficials': [{'name': 'Yongchang Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunan Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Director of Clinical Trial Center', 'investigatorFullName': 'Yongchang Zhang', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}}