Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-28 @ 2:35 AM
Study NCT ID:
NCT07171606
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'C053518', 'term': 'CP protocol'}, {'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-09-01', 'studyFirstSubmitQcDate': '2025-09-08', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '12 months'}, {'measure': 'Incidence and severity of Adverse Events', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'DCR : Disease Control Rate', 'timeFrame': '12 months'}, {'measure': 'PFS：Progression-Free Survival', 'timeFrame': '24 month'}, {'measure': 'OS：Overall Survival', 'timeFrame': '24 month'}, {'measure': 'The blood concentration of SSGJ-706', 'timeFrame': 'Approximately 6 months'}, {'measure': 'The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab)', 'timeFrame': 'Approximately 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['First-line Advanced NSCLC Patients']}, 'descriptionModule': {'briefSummary': 'This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC', 'detailedDescription': 'This study is a study of SSGJ-706 monotherapy and combination therapy for advanced NSCLC Patients. This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced NSCLC Patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and/or females over age 18\n2. Histologically and/or cytologically documented local advanced or metastatic NSCLC .\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Expected survival \\>=3 months.\n5. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Known uncontrolled or symptomatic central nervous system metastatic disease.\n2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \\>1 (National Cancer Institute Common terminology Criteria \\[NCI CTCAE\\] v.5.0).\n3. Inadequate organ or bone marrow function.\n4. Pregnant or breast-feeding woman.\n5. Known allergies, hypersensitivity, or intolerance to SSGJ-706\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT07171606', 'briefTitle': 'A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenyang Sunshine Pharmaceutical Co., LTD.'}, 'officialTitle': 'A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients', 'orgStudyIdInfo': {'id': 'SSGJ-706-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dose level 1 of SSGJ-706 monotherapy', 'interventionNames': ['Drug: SSGJ-706']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 2 of SSGJ-706 monotherapy', 'interventionNames': ['Drug: SSGJ-706']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 1 of SSGJ-706 combined with chemotherapy', 'interventionNames': ['Drug: SSGJ-706', 'Drug: pemetrexed /carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 2 of SSGJ-706 combined with chemotherapy', 'interventionNames': ['Drug: SSGJ-706', 'Drug: Carboplatin/Paclitaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PD-1/L1 combined with chemotherapy', 'interventionNames': ['Drug: PD-1 Inhibitor + Chemotherapy']}], 'interventions': [{'name': 'SSGJ-706', 'type': 'DRUG', 'description': 'PD-1/PD-L1 bispecific antibody', 'armGroupLabels': ['dose level 1 of SSGJ-706 combined with chemotherapy', 'dose level 1 of SSGJ-706 monotherapy', 'dose level 2 of SSGJ-706 combined with chemotherapy', 'dose level 2 of SSGJ-706 monotherapy']}, {'name': 'pemetrexed /carboplatin', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['dose level 1 of SSGJ-706 combined with chemotherapy']}, {'name': 'Carboplatin/Paclitaxel', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['dose level 2 of SSGJ-706 combined with chemotherapy']}, {'name': 'PD-1 Inhibitor + Chemotherapy', 'type': 'DRUG', 'description': 'control group', 'armGroupLabels': ['PD-1/L1 combined with chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengxiang Ren', 'role': 'CONTACT', 'email': 'harry_ren@126.com', 'phone': '13816756732'}], 'facility': 'Institute of The Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shengxiang Ren', 'role': 'CONTACT', 'email': 'harry_ren@126.com', 'phone': '13816756732'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenyang Sunshine Pharmaceutical Co., LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}