Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-01-01 @ 1:07 AM
Study NCT ID:
NCT06924606
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-04-06', 'studyFirstSubmitQcDate': '2025-04-06', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'the trough concentrations (PK)', 'timeFrame': '1.5years', 'description': 'to characterize the tough concentration of JS207\\&JS004'}, {'measure': 'Neutralizing antibody(Nab)', 'timeFrame': '1.5years', 'description': 'to characterize the neutralizing antibody of JS207\\&JS004'}, {'measure': 'Antidrug antibodies (ADA)', 'timeFrame': '1.5years', 'description': 'to characterize antidrug antibodies of JS207\\&JS004'}], 'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '1.5years', 'description': 'According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate objective response rate (ORR)'}], 'secondaryOutcomes': [{'measure': 'Disease control rate (DCR)', 'timeFrame': '2years', 'description': 'According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate disease control rate (DCR)'}, {'measure': 'Duration of response (DOR)', 'timeFrame': '2years', 'description': 'According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate duration of response (DOR)'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '1.5years', 'description': 'According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate progression-free survival (PFS)'}, {'measure': 'Overall survival (OS)', 'timeFrame': '2years', 'description': 'According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate overall survival (OS)'}, {'measure': 'AE', 'timeFrame': '2years', 'description': 'Incidence and serverity of adverse events(AE),abnormal changes in laboratory and other tests with clinical significance'}, {'measure': 'Abnormal changes in laboratory', 'timeFrame': '2years', 'description': 'Incidence and serverity of abnormal changes in laboratory and other tests with clinical significance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced NSCLC']}, 'descriptionModule': {'briefSummary': 'This is a multiple-arm, open phase II clinical trial evaluating the safety, tolerability,and preliminary efficacy of JS207 in NSCLC after progression following Platinum-based chemotherapy and immunotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) NSCLC that is not amenable to radical surgery or radical radiochemotherapy, or Metastatic or recurrent NSCLC.\n2. Patients with incurable locally advanced or metastatic or recurrent NSCLC who have experienced treatment failure with first-line treatment using a PD-1/PD-L1 inhibitor combined with platinum-based doublet chemotherapy (except docetaxel) or treatment failure with sequential first-line treatment using a PD-1/PD-L1 inhibitor and platinum-based doublet chemotherapy (except docetaxel) may be eligible. Previous treatments include anti-VEGF monoclonal antibody. For patients with operable early stage or locally advanced NSCLC who have received adjuvant and/or neoadjuvant therapy, radical radiotherapy or radiochemotherapy, disease progression or recurrence within 6 months after the last anti-tumor therapy, adjuvant/neoadjuvant/radiochemotherapy is considered as first-line therapy.\n3. Subjects must have at least one measurable lesion according to RECIST v1.1.\n\nExclusion Criteria:\n\n1. Histopathologically or cytopathologically confirmed to have combined neuroendocrine (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) component.\n2. Sensitivity mutation of EGFR or ALK fusion; known ROS1 fusion, BRAF V600E mutation, MET 14 exon skip mutation, RET fusion, etc. Gene mutation. The EGFR and ALK fusion status must be tested in patients with non-squamous cell carcinoma (the mutation status must be confirmed based on the tissue test if the blood test is negative); the genetic test is not mandatory for patients with squamous cell carcinoma.\n3. Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.'}, 'identificationModule': {'nctId': 'NCT06924606', 'briefTitle': 'Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Junshi Bioscience Co., Ltd.'}, 'officialTitle': 'A Phase II Clinical Study of JS207 (PD-1/VEGF Dual Antibody) Combined With Docetaxel in Patients With Advanced Non-small Cell Lung Cancer After Progression Following Platinum-based Chemotherapy and Immunotherapy', 'orgStudyIdInfo': {'id': 'JS207-004-II-NSCLC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w.', 'interventionNames': ['Drug: JS207 injection +docetaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w.', 'interventionNames': ['Drug: JS207 injection +JS004 injection']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C', 'description': 'Patients receive JS207 10mg/kg or other dosage .', 'interventionNames': ['Drug: JS207 injection']}], 'interventions': [{'name': 'JS207 injection +docetaxel', 'type': 'DRUG', 'description': 'Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w.', 'armGroupLabels': ['Arm A']}, {'name': 'JS207 injection +JS004 injection', 'type': 'DRUG', 'description': 'Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w.', 'armGroupLabels': ['Arm B']}, {'name': 'JS207 injection', 'type': 'DRUG', 'description': 'Patients receive JS207 10mg/kg or other dosage.', 'armGroupLabels': ['Arm C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '101100', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tongmei Zhang, Doctor', 'role': 'CONTACT'}, {'name': 'Tongmei Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Chest Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '130012', 'city': 'Jilin', 'state': 'Changchun', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Liu, Doctor', 'role': 'CONTACT'}, {'name': 'Ying Liu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jilin Cancer Hospital', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}, {'zip': '410031', 'city': 'Hunan', 'state': 'Changsha', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Wu, Doctor', 'role': 'CONTACT'}, {'name': 'Lin Wu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.71667, 'lon': 118.83333}}, {'zip': '610044', 'city': 'Sichuan', 'state': 'Chengdu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Panwen Tian, Doctor', 'role': 'CONTACT'}, {'name': 'Panwen Tian, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 35.1221, 'lon': 105.48032}}, {'zip': '400037', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bo Zhu, Doctor', 'role': 'CONTACT', 'email': '13618265332@163.com', 'phone': '023-68755404'}, {'name': 'Bo Zhu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Second Affiliated Hospital, PLA Academy of Military Medical Sciences', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mengxia Li, Doctor', 'role': 'CONTACT'}, {'name': 'Mengxia Li, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Army Medical Center, PLA', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xi Shi, Doctor', 'role': 'CONTACT', 'email': 'sxi91@163.com'}, {'name': 'Xi Shi, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '523000', 'city': 'Dongguan', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guanming Jiang, Doctor', 'role': 'CONTACT'}, {'name': 'Guanming Guanming, Guanming', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Medical Oncology', 'geoPoint': {'lat': 23.01797, 'lon': 113.74866}}, {'zip': '514031', 'city': 'Meizhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guowu Wu, Doctor', 'role': 'CONTACT', 'email': 'wanghongbiao123@qq.com'}, {'name': 'Guowu Wu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Meizhou People's Hospital", 'geoPoint': {'lat': 24.28859, 'lon': 116.11768}}, {'zip': '515031', 'city': 'Shantou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongbiao Wang, Doctor', 'role': 'CONTACT', 'email': 'wanghongbiao123@qq.com'}, {'name': 'Hongbiao Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shantou University Medical College Affiliated Cancer Hospital', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'zip': '510120', 'city': 'Guangdong', 'state': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chengzhi Zhou, Doctor', 'role': 'CONTACT'}, {'name': 'Chengzhi Zhou, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 42.76832, 'lon': 129.33635}}, {'zip': '310022', 'city': 'Zhejiang', 'state': 'Hangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Jin, Doctor', 'role': 'CONTACT'}, {'name': 'Ying Jin, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 25.3238, 'lon': 105.583}}, {'zip': '150081', 'city': 'Heilongjiang', 'state': 'Harbin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Yu, Doctor', 'role': 'CONTACT'}, {'name': 'Yan Yu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 28.26048, 'lon': 103.93137}}, {'zip': '455000', 'city': 'Anyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuanyuan Ji, Doctor', 'role': 'CONTACT', 'email': '13460856657@163.com'}, {'name': 'Yuanyuan Ji, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Anyang Tumor Hospital', 'geoPoint': {'lat': 36.096, 'lon': 114.38278}}, {'zip': '471003', 'city': 'Luoyang', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiye Zhang, Doctor', 'role': 'CONTACT', 'email': '54234317@qq.com'}, {'name': 'Zhiye Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Henan University of Science and Technology', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'zip': '453100', 'city': 'Xinxiang', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yinghua Ji, Doctor', 'role': 'CONTACT', 'email': '54234317@qq.com'}, {'name': 'Yinghua Ji, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Xinxiang Medical University', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '415003', 'city': 'Changde', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhijun Wu, Doctor', 'role': 'CONTACT', 'email': '1056068115@qq.com'}, {'name': 'Zhijun Wu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The First People's Hospital of Changde", 'geoPoint': {'lat': 29.03205, 'lon': 111.69844}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongzhong Luo, Doctor', 'role': 'CONTACT'}, {'name': 'Yongzhong Luo, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '330000', 'city': 'Jiangxi', 'state': 'Nanchang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Longhua Sun, Doctor', 'role': 'CONTACT'}, {'name': 'Longhua Sun, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 33.99934, 'lon': 105.19994}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tianqing Chu, Doctor', 'role': 'CONTACT'}, {'name': 'Tianqing Chu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng Zhang, Doctor', 'role': 'CONTACT'}, {'name': 'Peng Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '037008', 'city': 'Datong', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chengxu Cui, Doctor', 'role': 'CONTACT', 'email': 'zhongliuke666@163.com'}, {'name': 'Chengxun Cui, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Third People's Hospital of Datong", 'geoPoint': {'lat': 40.09361, 'lon': 113.29139}}, {'zip': '644000', 'city': 'Yibin', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xujuan Ye, Doctor', 'role': 'CONTACT', 'email': 'xujuanye2008@163.com'}, {'name': 'Xujuan Ye, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Yibin Second People's Hospital", 'geoPoint': {'lat': 28.7593, 'lon': 104.63994}}, {'zip': '830011', 'city': 'Xinjiang', 'state': 'Xinjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhigang Han, Doctor', 'role': 'CONTACT', 'email': '1378213986@qq.com'}, {'name': 'Zhigang Han, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Tumor Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 40.91904, 'lon': 110.38311}}, {'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanfan Chen, Doctor', 'role': 'CONTACT', 'email': 'sxi91@163.com'}, {'name': 'Yanfan Chen, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'zip': '200433', 'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunxia Su, Doctor', 'role': 'CONTACT', 'email': 'susu_mail@126.com'}, {'name': 'Chunxia Su, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiaojun Wang, Master', 'role': 'CONTACT', 'email': 'xiaojun_wang@junshipharma.com', 'phone': '021-50796193'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Junshi Bioscience Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}