Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT05377658
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2022-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'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'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Complete Response (pCR) Rate', 'timeFrame': 'At time of surgery', 'description': 'defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.'}], 'secondaryOutcomes': [{'measure': 'Major Pathological Response (MPR) Rate', 'timeFrame': 'At time of surgery', 'description': 'defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.'}, {'measure': 'Incidence of Surgical Complications', 'timeFrame': 'Up to approximately 30 days following surgery', 'description': 'defined as ≥ grade 3 or severe intraoperative and perioperative complications.'}, {'measure': 'Complete (R0) Resection Rate', 'timeFrame': 'After surgery (approximately 7 weeks)', 'description': 'defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'At the end of 3 cycles of neoadjuvant therapy (each cycle is 21 days)', 'description': 'defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.'}, {'measure': 'Event Free Survival (EFS)', 'timeFrame': 'Up to approximately 5 years', 'description': 'defined as the time from the first dose of study drug to disease progression per RECIST 1.1 that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': 'From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neoadjuvant and adjuvant therapy', 'bispecific antibody'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'AK104, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of AK104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.\n3. Have at least one measurable lesion per RECIST 1.1 assessed by investigator.\n4. Have adequate organ function.\n\nKey Exclusion Criteria:\n\n1. Mixed NSCLC and small cell lung cancer histology.\n2. Patients with other active malignancies within 3 years prior to enrollment.\n3. Known active autoimmune diseases.\n4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.\n5. Presence of other uncontrolled serious medical conditions.'}, 'identificationModule': {'nctId': 'NCT05377658', 'briefTitle': 'AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'A Single-Arm, Phase II Study of AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'AK104-IIT-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AK104+albumin-bound paclitaxel+carboplatin', 'description': 'Participants receive 3 cycles of AK104 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy prior to surgery; followed by surgery; followed by adjuvant AK104 for 9 cycles.', 'interventionNames': ['Drug: AK104', 'Drug: Albumin-Bound Paclitaxel', 'Drug: Carboplatin']}], 'interventions': [{'name': 'AK104', 'type': 'DRUG', 'otherNames': ['Cadonilimab'], 'description': '10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['AK104+albumin-bound paclitaxel+carboplatin']}, {'name': 'Albumin-Bound Paclitaxel', 'type': 'DRUG', 'description': '260mg/m\\^2 via intravenous infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['AK104+albumin-bound paclitaxel+carboplatin']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['AK104+albumin-bound paclitaxel+carboplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huijuan Wang, MD', 'role': 'CONTACT', 'email': '18638561588@163.com', 'phone': '18638561588'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Huijuan Wang, MD', 'role': 'CONTACT', 'email': '18638561588@163.com', 'phone': '18638561588'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Huijuan Wang', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}