Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-26 @ 8:51 PM
Study NCT ID:
NCT04672356
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2020-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632826', 'term': 'sintilimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-18', 'studyFirstSubmitDate': '2020-12-13', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '3 months'}, {'measure': 'Recommended Phase II Dose(RP2D)', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Objective response rate(ORR)', 'timeFrame': '6 months', 'description': 'Proportion of subjects with complete response (CR) or partial response (PR).'}, {'measure': 'Disease Control Rate(DCR)', 'timeFrame': '6 months', 'description': 'Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).'}, {'measure': 'Time to Objective Response (TTR)', 'timeFrame': '6 months', 'description': 'Time from randomization to first objective tumor response (CR or PR).'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': '6 months', 'description': 'The time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death.'}, {'measure': 'Progression-free survival(PFS)', 'timeFrame': '6 months', 'description': 'The time from randomization to the first occurrence of objective disease progression or death'}, {'measure': 'Area under the plasma concentration-time curve (AUC)', 'timeFrame': '24 hours'}, {'measure': 'Maximum concentration (Cmax)', 'timeFrame': '24 hours'}, {'measure': 'Trough concentration (Cmin)', 'timeFrame': '24 hours'}, {'measure': 'Clearance (CL)', 'timeFrame': '24 hours'}, {'measure': 'Volume of distribution (V)', 'timeFrame': '24 hours'}, {'measure': 'Half-life (t1/2)', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed the Informed Consent Form;\n2. Male or female ≥ 18 and≤75 years of age;\n3. Life expectancy ≥ 12 weeks;\n4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1\n5. Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter ≥ 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis ≥ 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements.\n6. Histologically or cytologicallyconfirmed non-small cell lung or small cell lung cancer\n\nExclusion Criteria:\n\n1. Previous exposure to immune-mediated therapy; previous use of antitumor vaccine;\n2. Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug;\n3. Received any investigational agent within 4 weeks prior to the first dose of study drug;\n4. Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;\n5. Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;'}, 'identificationModule': {'nctId': 'NCT04672356', 'briefTitle': 'A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics (Suzhou) Co. Ltd.'}, 'officialTitle': 'An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer', 'orgStudyIdInfo': {'id': 'CIBI939A102(Ia)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase Ia: IBI939 in combination with Sintilimab', 'description': 'IBI939 10mg/kg combination with Sintilimab', 'interventionNames': ['Biological: IBI939', 'Biological: Sintilimab']}, {'type': 'EXPERIMENTAL', 'label': 'Phase Ia:IBI939 in combination with Sintilimab', 'description': 'IBI939 20mg/kg combination with Sintilimab', 'interventionNames': ['Biological: IBI939', 'Biological: Sintilimab']}], 'interventions': [{'name': 'IBI939', 'type': 'BIOLOGICAL', 'description': 'IBI939 injection', 'armGroupLabels': ['Phase Ia: IBI939 in combination with Sintilimab', 'Phase Ia:IBI939 in combination with Sintilimab']}, {'name': 'Sintilimab', 'type': 'BIOLOGICAL', 'description': 'Sintilimab injection', 'armGroupLabels': ['Phase Ia: IBI939 in combination with Sintilimab', 'Phase Ia:IBI939 in combination with Sintilimab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jilin', 'country': 'China', 'facility': 'Jilin Province Cancer Hospital', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}], 'overallOfficials': [{'name': 'Ying Cheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jilin Province Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}