Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-31 @ 11:08 PM
Study NCT ID:
NCT05215067
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-12
First Post:
2022-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2022-01-18', 'studyFirstSubmitQcDate': '2022-01-18', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 2 years'}], 'secondaryOutcomes': [{'measure': 'Number of patients with Adverse Events (AEs)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) Of AK104', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Antidrug antibodies (ADA) of AK104', 'timeFrame': 'Up to approximately 2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Phase II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) combined with Docetaxel in Advanced Non-Small Cell Lung Cancer whose disease has progressed after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 to 75 years old.\n2. Have a life expectancy of at least 3 months.\n3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Has a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.\n5. Has radiographic progression after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody (mAb) administered.\n6. No known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.\n7. Has at least 1 measurable lesion per RECIST 1.1 assessed by investigator.\n8. Has adequate organ function.\n\nExclusion Criteria:\n\n1. Undergone major surgery within 30 days prior to the first dose of study treatment.\n2. Active central nervous system (CNS) metastases.\n3. History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).\n4. Active Hepatitis B or Hepatitis C.\n5. Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.\n6. Has received treatment with docetaxel.\n7. History of severe bleeding tendency or coagulation disorder.'}, 'identificationModule': {'nctId': 'NCT05215067', 'briefTitle': 'A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akeso'}, 'officialTitle': 'A Phase II Trial of AK104 in Combination With Docetaxel in Subjects With Advanced Non-Small Cell Lung Cancer and Progressive Disease After Platinum Doublet Chemotherapy and Treatment With One Prior Anti-PD-1/PD-L1 Monoclonal Antibody (mAb)', 'orgStudyIdInfo': {'id': 'AK104-215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AK104 plus Docetaxel', 'description': 'AK104 RP2D + Docetaxel 75mg/m\\^2 every 3 weeks until progressive disease or unacceptable toxicity.', 'interventionNames': ['Drug: AK104', 'Drug: Docetaxel']}], 'interventions': [{'name': 'AK104', 'type': 'DRUG', 'description': 'IV infusion,Specified dose on specified days', 'armGroupLabels': ['AK104 plus Docetaxel']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'IV infusion,Specified dose on specified days', 'armGroupLabels': ['AK104 plus Docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Cancer Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akeso', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}