Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT06352008
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule in Postoperative Non-pCR Patients With 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': 'C000625192', 'term': 'anlotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-02', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-Free Survival (EFS)', 'timeFrame': '2 years', 'description': 'Defined as the time from the first dose administration to the occurrence of any of the following "events": 1. Non-small cell lung cancer recurrence/metastasis confirmed by pathology or imaging; 2. Disease progression; 3. All-cause death (whichever occurs first).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'To explore the effectiveness of anlotinib hydrochloride capsule in postoperative non-pCR non-small cell lung cancer patients with adjuvant intensive therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;\n2. ≥18 years old (calculated by the date of signing the informed consent); Both men and women; ECOG score 0\\~1; Expected survival ≥3 months;\n3. Patients with stage IIA-IIIA NSCLC who had previously received PD-1/PD-L1 inhibitors combined with chemotherapy neoadjuvant therapy and underwent R0 resection for curative purposes before surgery (note: the disease was presented in the American Joint Committee on Cancer (AJCC)/Union International Against Cancer (UICC) 8th edition of lung cancer TNM staging);\n4. For patients who did not achieve pathological complete response after PD-1/PD-L1 inhibitor combined with chemotherapy neoadjuvant treatment, and the time between the first trial medication after surgery was required to be 4-12 weeks;\n5. The main organs function well and meet the standards;\n6. Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\n1. Have had or are currently suffering from other malignant tumors within 5 years. The following two conditions can be included: other malignancies treated with a single operation, achieving continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)\\];\n2. Subjects are known to have genetic abnormalities that have been approved for targeted drug therapy (non-squamous cell carcinoma subjects are required to have EGFR or ALK gene tested or provide previous test reports during the screening period)\n3. Cardiovascular and cerebrovascular abnormalities:\n\n 1. Patients with past or existing heart failure, degree II or higher heart block;\n 2. Past or present myocardial infarction or unstable angina pectoris, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;\n 3. Occurrence of arteriovenous thrombosis/cancer embolus events within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction requiring clear diagnosis), vascular embolism (including deep vein thrombosis, arterial thrombosis, pulmonary embolism, etc.);\n4. Participated in other drug clinical trials within the past 30 days;\n5. Within 2 weeks before starting the administration, it has been treated with Chinese patent medicines (including compound Cantharides capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Bruceae oil injection/capsule, Xiaoaipingtablet/injection, hualbufatin capsule, etc.) with anti-tumor indications specified in the NMPA approved drug instructions;\n6. Received major surgery other than radical resection of lung cancer within 4 weeks prior to initiation of administration; According to the investigator, the patient was not eligible to participate in this clinical study for other reasons.'}, 'identificationModule': {'nctId': 'NCT06352008', 'briefTitle': 'To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule in Postoperative Non-pCR Patients With Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule in Postoperative Non-pCR Patients With Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'E20230553'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experiment', 'interventionNames': ['Drug: Anlotinib']}], 'interventions': [{'name': 'Anlotinib', 'type': 'DRUG', 'description': '12mg once a day, taken orally before breakfast for 2 consecutive weeks and stopped for 1 week. Without special circumstances, it is recommended to take at a fixed time every day; If there is a missing dose during the administration, confirm that the time before the next administration is less than 12 hours, no more refilling. The maximum duration of drug use is tentatively 1 year.', 'armGroupLabels': ['experiment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'role': 'CONTACT', 'phone': '+008618526812877'}], 'facility': 'Tianjin Medical University Cancer Institute & Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Zhansheng', 'role': 'CONTACT', 'email': '18526812877@163.com', 'phone': '008618526812877'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}