Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-30 @ 9:11 AM
Study NCT ID:
NCT05071703
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2021-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'C000708352', 'term': 'trilaciclib'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2021-09-28', 'studyFirstSubmitQcDate': '2021-09-28', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of severe neutropenia (SN)', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months', 'description': 'Incidence of severe neutropenia (SN)'}], 'secondaryOutcomes': [{'measure': 'Incidence of grade 3 and 4 hematologic toxicity', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'Incidence of intravenous or oral antibiotic administration in treatment', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'Incidence of G-CSF treatment', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'Changes of absolute neutrophil count, platelet count, absolute lymphocyte count (ALC) and hemoglobin over time', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'Incidence of red blood cell (RBC) transfusions at or after week 5', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'The incidence of ESA administration in treatment', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'The incidence of TPO administration in treatment', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'The incidence of platelet transfusion', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'The number and frequency of all-caused chemotherapy drugs reduction', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'composite end point - Significant hematologic adverse event (occurrence of any of the following events：all-cause hospitalization; all-cause dose reduction; Febrile neutropenia; Severe neutropenia )', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'Incidence of infectious serious adverse events', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'Incidence of pulmonary infection serious adverse events', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'The incidence of febrile neutropenia', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'Objective response rate', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'duration of response', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'Progression-free survival time', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 6 months'}, {'measure': 'Disease control rate', 'timeFrame': 'during chemotherapy assessed up to 6 months'}, {'measure': 'verall survival', 'timeFrame': 'maximun up to 1.5 years'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extensive-stage Small-cell Lung Cancer']}, 'descriptionModule': {'briefSummary': "This is a single-arm, real-world study in Chinese patients with extensive stage small cell lung cancer. The purpose of this study was to evaluate Trilaciclib's protection against chemotherapy-induced bone marrow suppression, the safety and the impact on the antitumor effects of the combination with chemotherapy in Chinese patients with ES-SCLC in the real world. Patients with ES-SCLC who already use or plan to use Trilaciclib will be invited to participate in the study. Data were collected from 28 days prior to initial chemotherapy (platinum/etoposide or topotecan systemic chemotherapy) after patients signed informed consent until patients died, dropped out of the study, lost to follow-up, informed withdrawal, or study termination. The end time of the study was defined as withdrawal of information, loss of follow-up or death of all enrolled patients, or 12 months after the last patient was enrolled, whichever happened earlier."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntarily participate and sign informed consent;\n2. must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender:\n3. Patients with extensive small-cell lung cancer confirmed by histology or cytology\n4. Patients suitable for Trilaciclib combined with platinum/etoposide or Trilaciclib combined with topotecan treatment\n\nExclusion Criteria:\n\n1. Patient is currently participating in other Interventional clinical studies;\n2. Patients received systemic chemotherapy other than the regimens recommended in inclusion criteria 4 During Trilaciclib treatment.'}, 'identificationModule': {'nctId': 'NCT05071703', 'briefTitle': 'Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Simcere Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study', 'orgStudyIdInfo': {'id': 'Trila-CN-RWS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trilaciclib, carboplatin, etoposide, Topotecan', 'description': 'Trilaciclib plus Carboplatin combined with Etoposide OR Topotecan (ES-SCLC patients)', 'interventionNames': ['Drug: Trilaciclib']}], 'interventions': [{'name': 'Trilaciclib', 'type': 'DRUG', 'otherNames': ['Trilaciclib, carboplatin, etoposide#or Topotecan'], 'description': '* Carboplatin combined with Etoposide (ES-SCLC patients)\n* plus Topotecan (second/third line ES-SCLC patients)', 'armGroupLabels': ['Trilaciclib, carboplatin, etoposide, Topotecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': 'Hainan General Hospital', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}], 'overallOfficials': [{'name': 'Yongxing Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hainan General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Simcere Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'G1 Therapeutics, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}