Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2025-12-26 @ 1:44 AM
Study NCT ID:
NCT06208033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-17
First Post:
2024-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656314', 'term': 'toripalimab'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077143', 'term': 'Docetaxel'}], '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': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of adverse events', 'timeFrame': '1 year', 'description': 'Adverse events incidence refers to the frequency of adverse events'}, {'measure': 'rate of adverse events', 'timeFrame': '1 year', 'description': 'All adverse events will also be rated based on the NCI CTCAE version 5.0.'}, {'measure': 'Laboratory aberrations', 'timeFrame': '1 year', 'description': 'Laboratory outliers refer to measurement results that significantly deviate from the normal reference range in laboratory testing.'}], 'secondaryOutcomes': [{'measure': 'disease control rate', 'timeFrame': '1 year', 'description': 'Disease control rate: DCR'}, {'measure': 'Progression-free survival', 'timeFrame': '1 year', 'description': 'Progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1 criteria'}, {'measure': 'DOR（ Duration of Response）', 'timeFrame': '1 year', 'description': 'Duration of response (DoR) is defined as the time from first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression as determined per investigator assessment using RECIST 1.1 criteria or death due to any cause, whichever occurs first.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['EGFR Positive Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, sequential study assessing the efficacy and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced non-small cell lung cancer (NSCLC) : first-line treatment or failed from first-line immune checkpoint inhibitor treatment.The primary objective is to evaluate the anti-tumor activity and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Has fully understood and voluntarily signed an informed consent form for this study , willing and able to comply with study procedures.\n\n 2\\. Age ≥ 18 years. 3. Histologically confirmed EGFR positive (immunohistochemistry ≥ \\[+\\]) advanced NSCLC ,including: (1) Cohort A: Treatment-naïve subjects; (2) Cohort B: Subjects resistant to first-line treatment contain immune checkpoint inhibitors (stability period \\> 3 months).\n\n 4\\. At least one measurable lesion via RECIST v1.1 criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 6. Expected survival ≥ 3 months. 7. Adequate organ function .\n\nExclusion Criteria:\n\n* 1\\. Driver gene-positive (EGFR, ALK, ROS1) . 2. history of dual primary malignancies within the past 5 years. 3. active autoimmune diseases or a history of autoimmune disorders requiring systemic corticosteroid therapy.\n\n 4\\. systemic infections requiring systemic treatment. 5. known central nervous system metastases or other central nervous system diseases or abnormalities deemed unsuitable for inclusion in this study by the investigator.\n\n 6\\. Fertile individuals unable to maintain effective contraception during the trial.\n\n 7\\. Subjects in Cohort B who have received prior docetaxel treatment. 8. Subjects in Cohort B who experienced Grade 3 or higher immune-related adverse events during first-line treatment with immune checkpoint inhibitors.\n\n 9\\. Individuals deemed unsuitable for participation in this clinical trial by the investigator for various reasons .'}, 'identificationModule': {'nctId': 'NCT06208033', 'briefTitle': 'SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'A Single-arm, Sequential Study Assessing the Efficacy and Safety of SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC) : First-line Treatment or Failed From First-line Immune Checkpoint Inhibitor Treatment.', 'orgStudyIdInfo': {'id': 'SCOG009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment-naïve subjects with EGFR positive advanced Lung Adenocarcinoma', 'description': 'toripalimab：3mg/kg， Q2W； SMET12：60μg，Q2W； Pemetrexed Disodium 500mg/m2 d+Carboplatin AUV＝5 d1 Q3W，administered for 2\\~4 cycles', 'interventionNames': ['Drug: SMET12']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment-naïve subjects with EGFR positive advanced Lung Squamous Cell Carcinoma', 'description': 'toripalimab：3mg/kg， Q2W； SMET12：60μg，Q2W； paclitaxel 100mg/m2 d1，d8，d15+cisplatin 75mg/m2 d1 Q3W， administered for 2\\~4 cycles', 'interventionNames': ['Drug: SMET12']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects resistant to first-line treatment contain immune checkpoint inhibitors', 'description': 'toripalimab：3mg/kg， Q2W； SMET12：60μg，Q2W； Docetaxel 60-75 mg/m2 d1Q3W，administered for 2\\~4 cycles', 'interventionNames': ['Drug: SMET12']}], 'interventions': [{'name': 'SMET12', 'type': 'DRUG', 'otherNames': ['toripalimab', 'Pemetrexed Disodium', 'Carboplatin'], 'description': '1. platinum-containing two-drug chemotherapy：Carboplatin plus Pemetrexed Disodium, administrated for 2-4 cycles, three weeks for one cycyles;Carboplatin 500mg/m2 d1,Pemetrexed Disodium AUV＝5 d1,Q3W;\n2. Toripalimab, IV, 3mg/kg，Q2W；\n3. SMET12: IV，60μg，Q2W，injected the day after toripalimab ；', 'armGroupLabels': ['Treatment-naïve subjects with EGFR positive advanced Lung Adenocarcinoma']}, {'name': 'SMET12', 'type': 'DRUG', 'otherNames': ['toripalimab', 'paclitaxel', 'cisplatin'], 'description': '1. platinum-containing two-drug chemotherapy：Carboplatin plus Pemetrexed Disodium, administrated for 2-4 cycles, 3 weeks for one cycle.cisplatin 75mg/m2 d1 Q3W,paclitaxel 100mg/m2 d1，d8，d15;\n2. Toripalimab, IV, 3mg/kg，Q2W；\n3. SMET12: IV，60μg，Q2W，injected the day after toripalimab ；', 'armGroupLabels': ['Treatment-naïve subjects with EGFR positive advanced Lung Squamous Cell Carcinoma']}, {'name': 'SMET12', 'type': 'DRUG', 'otherNames': ['toripalimab', 'Docetaxel'], 'description': '1. chemotherapy：Docetaxel 60-75 mg/m2 d1, administrated for 2-4 cycles, 3 weeks for one cycle.\n2. Toripalimab, IV, 3mg/kg，Q2W；\n3. SMET12: IV，60μg，Q2W，injected the day after toripalimab ；', 'armGroupLabels': ['Subjects resistant to first-line treatment contain immune checkpoint inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'country': 'China', 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Zhiyong He', 'role': 'CONTACT', 'email': 'heyong1015@163.com', 'phone': '+86 138 0508 6391'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}