Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-25 @ 3:21 PM
Study NCT ID:
NCT06536868
Status:
RECRUITING
Last Update Posted:
2024-08-05
First Post:
2024-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC
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': 'C000707970', 'term': 'tislelizumab'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2024-07-31', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to 2 years', 'description': 'From the date of enrollment to the date of disease progression'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 2 years', 'description': 'ORR as assessed by the Investigator according to RECIST v1.1'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to 2 years', 'description': 'DCR as assessed by the Investigator according to RECIST v1.1'}, {'measure': 'Overall Survival （OS）', 'timeFrame': 'Up to 2 years', 'description': 'From the date of enrollment until death by any cause or last follow-up'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 2 years', 'description': 'Treatment-related adverse events according to CTCAE 5.0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extensive-stage Small-cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 to 80 years old (inclusive of 18th and 80th birthdays), male or female, at the time of signing the informed consent form;\n* Confirmed small cell lung cancer of extensive stage by histology or cytology;\n* At least one measurable lesion by imaging studies (according to RECIST 1.1) with a long diameter of ≥10 mm as examined by spiral CT or MRI;\n* Within 3 days prior to treatment, an ECOG score of 0 to 1;\n* No prior antitumor treatment for extensive stage disease (if the patient has previously received chemotherapy and/or radiotherapy in the limited stage of SCLC, the treatment intent must have been curative, and there must be at least a 6-month treatment-free interval between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive stage SCLC);\n* Expected life span of ≥3 months;\n* Good function of vital organs;\n* The subject voluntarily joins this study, signs the informed consent form, has good compliance, and cooperates with follow-up.\n\nExclusion Criteria:\n\n* Concurrent severe respiratory diseases: such as pulmonary fibrosis;\n* Presence of psychiatric disorders, hematologic diseases, autoimmune diseases, and severe primary diseases of the heart, brain, liver, or kidneys;\n* Uncontrolled active infections;\n* Known or suspected allergies to the study medication and its excipients;\n* Female patients who are pregnant or breastfeeding, or women of childbearing potential with a positive baseline pregnancy test;\n* Prior use of antitumor treatment targeting the PD-(L)1 pathway.'}, 'identificationModule': {'nctId': 'NCT06536868', 'briefTitle': 'Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC', 'organization': {'class': 'OTHER', 'fullName': 'Second Hospital of Shanxi Medical University'}, 'officialTitle': 'Tislelizumab Plus Chemotherapy and Concurrent Thoracic Radiotherapy as First-line Therapy for Extensive-stage Small-Cell Lung Cancer (ES-SCLC): an Multicenter, Single Arm Prospective Trial', 'orgStudyIdInfo': {'id': '[2024] YX No. 274'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICI+EC/EP+TRT', 'description': 'Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin', 'interventionNames': ['Drug: Tislelizumab', 'Drug: Etoposide', 'Drug: Carboplatin or Cisplatin', 'Radiation: Thoracic radiotherapy']}], 'interventions': [{'name': 'Tislelizumab', 'type': 'DRUG', 'description': 'Tislelizumab infusion will be administered for 2 years (200mg, day1, Q3W).', 'armGroupLabels': ['ICI+EC/EP+TRT']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Etoposide intravenous infusion will be administered during the induction phase (100mg/㎡, day1-3 Q3W for 4 cycles).', 'armGroupLabels': ['ICI+EC/EP+TRT']}, {'name': 'Carboplatin or Cisplatin', 'type': 'DRUG', 'description': 'Carboplatin or Cisplatin intravenous infusion will be administered during the induction phase (Carboplatin AUC5, Q3W for 4 cycles; Cisplatin 75mg/㎡, Q3W for 4 cycles).', 'armGroupLabels': ['ICI+EC/EP+TRT']}, {'name': 'Thoracic radiotherapy', 'type': 'RADIATION', 'description': 'IMRT 30-45Gy/10-15f', 'armGroupLabels': ['ICI+EC/EP+TRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '048000', 'city': 'Jincheng', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xueqin Li, Dr.', 'role': 'CONTACT', 'phone': '+86 356 3661360'}], 'facility': 'Jincheng General Hospital', 'geoPoint': {'lat': 35.50222, 'lon': 112.83278}}, {'zip': '032000', 'city': 'Jinzhong', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qian Wu, Dr.', 'role': 'CONTACT', 'phone': '+86 354 3532157'}], 'facility': "Jinzhong third people's hospital", 'geoPoint': {'lat': 37.68403, 'lon': 112.75471}}, {'zip': '030000', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gang Jin, Dr.', 'role': 'CONTACT', 'phone': '+86 351 3365422'}], 'facility': 'Second Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '030000', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huijing Feng, Dr.', 'role': 'CONTACT', 'phone': '+86 351 8368114'}], 'facility': 'Shanxi Bethune Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '030000', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinyang Bai, Dr.', 'role': 'CONTACT', 'phone': '+86 351 303009'}], 'facility': 'Shanxi Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '030000', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weihua Jia, Dr.', 'role': 'CONTACT', 'phone': '+86 351 3012448'}], 'facility': 'TISCO General Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'centralContacts': [{'name': 'Gang Jin, Dr.', 'role': 'CONTACT', 'email': 'jingang2018@sina.com', 'phone': '+86 351 3365422'}, {'name': 'Chen Zhang', 'role': 'CONTACT', 'email': 'jingang2018@sina.com', 'phone': '+86 351 3365422'}], 'overallOfficials': [{'name': 'Gang Jin, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Hospital of Shanxi Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Hospital of Shanxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Gang Jin', 'investigatorAffiliation': 'Second Hospital of Shanxi Medical University'}}}}