Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-01 @ 2:43 PM
Study NCT ID:
NCT06334757
Status:
UNKNOWN
Last Update Posted:
2024-03-28
First Post:
2024-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D016190', 'term': 'Carboplatin'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR(Overall Response Rate)', 'timeFrame': 'From start of treatment to 12 months', 'description': 'The proportion of subjects who have a complete response (CR) or a partial response (PR)'}], 'secondaryOutcomes': [{'measure': 'PFS(Progression Free Survival)', 'timeFrame': 'From start of treatment to 24 months', 'description': 'Time from enrollment to first disease progression assessed by investigator or death due to any cause'}, {'measure': 'OS(Overall Survival)', 'timeFrame': 'From start of treatment to 24 months', 'description': 'Time from enrollment to the death of the subject due to any cause'}, {'measure': 'AE(Adverse Event)', 'timeFrame': 'From start of treatment to 24 months', 'description': 'incidece of adverse drug event'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Squamous Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Serplulimab Plus Bevacizumab and chemotherapy in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written informed consent before any trial-related processes;\n2. Age ≥ 18 years and ≤70 years male or females;\n3. Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer \\[AJCC\\] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;\n4. Patients with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment\n5. EGFR-TKI resistance, confirmed by RECIST 1.1\n6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;\n\nExclusion Criteria:\n\n1. History of severe allergies to any study drug\n2. Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other stimulatory or inhibitory agents of T cell receptors\n3. Previous exposure to VEGF inhibitor for anti-cancer treatment\n4. Patients with untreated symptomatic brain metastases. Patients with treated brain metastases will be allowed if brain imaging obtained greater than 4 weeks from trial enrollment reveals stable disease.\n5. Has received a live-virus vaccination within 28 days of planned treatment start\n6. Interstitial lung disease or pneumonitis requiring oral or IV glucocorticoids Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study'}, 'identificationModule': {'nctId': 'NCT06334757', 'briefTitle': 'Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Serplulimab Plus Bevacizumab and Chemotherapy for EGFRm+ Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure', 'orgStudyIdInfo': {'id': 'HLX10IIT22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serplulimab+Bevacizumab+Pemetrexed+Carboplatin', 'description': 'Using Serplulimab in combination with bevacizumab, carboplatin and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors.', 'interventionNames': ['Drug: Serplulimab', 'Drug: Bevacizumab Biosimilar HLX04', 'Drug: Pemetrexed', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Serplulimab', 'type': 'DRUG', 'otherNames': ['HLX10'], 'description': '300 mg，IV，Q3W', 'armGroupLabels': ['Serplulimab+Bevacizumab+Pemetrexed+Carboplatin']}, {'name': 'Bevacizumab Biosimilar HLX04', 'type': 'DRUG', 'otherNames': ['HLX04'], 'description': '7.5 mg/kg，Q3W', 'armGroupLabels': ['Serplulimab+Bevacizumab+Pemetrexed+Carboplatin']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': '500 mg/m2，IV，Q3W', 'armGroupLabels': ['Serplulimab+Bevacizumab+Pemetrexed+Carboplatin']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'AUC=5，IV，Q3W', 'armGroupLabels': ['Serplulimab+Bevacizumab+Pemetrexed+Carboplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhen he', 'role': 'CONTACT', 'phone': '13523530961'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'zhen he', 'role': 'CONTACT', 'email': '13523530961@126.com', 'phone': '+86 13523530961'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}