Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-25 @ 3:11 PM
Study NCT ID:
NCT04699968
Status:
WITHDRAWN
Last Update Posted:
2023-06-07
First Post:
2021-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of SHR-1701 With or Without Famitinib in Patients With Advanced or Metastatic NSCLC
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': 'C000723862', 'term': 'SHR-1701'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'SHR-1701 with or without Famitinib'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor R \\& D Strategy Adjustment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'determined by RECIST v1.1, up to approximately 1 year', 'description': 'Objective Response Rate'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'determined by RECIST v1.1, up to approximately 1 year', 'description': 'Progression-Free-Survival'}, {'measure': 'DCR', 'timeFrame': 'determined by RECIST v1.1, up to approximately 1 year', 'description': 'Disease Control Rate'}, {'measure': 'DoR', 'timeFrame': 'determined by RECIST v1.1, up to approximately 1 year', 'description': 'Duration of Response'}, {'measure': 'OS', 'timeFrame': 'up to approximately 1 year', 'description': 'Overall Survival'}, {'measure': 'AEs+ SAEs', 'timeFrame': 'determined by NCI-CTCAE V5.0, from the first drug administration to within 90 days for the last SHR-1701 dose', 'description': 'Adverse Events and Serious Adverse Events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small-Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the efficacy and safety of SHR-1701 with or without famitinib in patients with advanced or metastatic NSCLC'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. voluntarily participate in the study and sign the informed consent form;\n2. 18 to 75 years old, both male and female;\n3. histologically or cytologically confirmed stage IIIB-IV or recurrent NSCLC\n4. one prior platinum-containing chemotherapy for advanced or metastatic disease;\n5. measurable lesions by RECIST v1.1;\n6. ECOG score: 0-1;\n7. life expectancy ≥ 3 months;\n8. adequate hematological, hepatic and renal function;\n9. non-surgically sterile female subjects of childbearing age must have a negative serum HCG test.\n\nExclusion Criteria:\n\n1. histologically or cytologically confirmed mixed SCLC and NSCLC;\n2. known sensitising EGFR mutation and/or ALK translocation in patients with non-squamous NSCLC;\n3. tumor infiltration into the great vessels on imaging;\n4. active CNS metastases;\n5. malignancies other than NSCLC within 5 years;\n6. anticancer therapy within 4 weeks before the start of trial treatment;\n7. persisting toxicity related to prior therapy of Grade \\> 1;\n8. treatment with systemic immunostimulatory agents within 4 weeks;\n9. treatment with systemic immunosuppressive agents within 2 weeks;\n10. autoimmune diseases;\n11. interstitial lung disease or other lung diseases that is symptomatic or may interfere the management of suspected drug-related pulmonary toxicity;\n12. clinically significant cardiovascular or cerebrovascular diseases;\n13. inadequately controlled hypertension;\n14. history of hemoptysis (≥ 2.5mL of bright red blood per episode) within 1 month;\n15. venous or arterial thrombosis within 6 months;\n16. evidence of bleeding diathesis or coagulopathy;\n17. use of anticoagulants or thrombolytic agents that has not been stable;\n18. active Tuberculosis infection;\n19. significant acute or chronic infections within 1 month;\n20. known history of testing positive test for HIV or known AIDS;\n21. hepatitis B virus or hepatitis C virus infection;\n22. allergic to any component of the treatment regimen;\n23. other conditions that in the opinion of the investigator would make participation in this clinical trial inappropriate.'}, 'identificationModule': {'nctId': 'NCT04699968', 'briefTitle': 'A Trial of SHR-1701 With or Without Famitinib in Patients With Advanced or Metastatic NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Phase II Clinical Trial of SHR-1701 With or Without Famitinib in the Treatment of Advanced or Metastatic NSCLC', 'orgStudyIdInfo': {'id': 'SHR-1701-Ⅱ-206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A', 'interventionNames': ['Drug: SHR-1701，Famitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group B', 'interventionNames': ['Drug: SHR-1701']}], 'interventions': [{'name': 'SHR-1701，Famitinib', 'type': 'DRUG', 'description': 'SHR -1701, Intravenous ；Famitinib, oral', 'armGroupLabels': ['Treatment group A']}, {'name': 'SHR-1701', 'type': 'DRUG', 'description': 'SHR -1701, Intravenous', 'armGroupLabels': ['Treatment group B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}