Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT06561620
Status:
RECRUITING
Last Update Posted:
2024-08-22
First Post:
2024-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Befotertinib Adjuvant Therapy in Stage IA2-IB NSCLC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 592}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2029-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2024-08-16', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year disease-free survival', 'timeFrame': '3 years', 'description': '3-year disease-free survival after complete resection in patients with MRD-positive EGFR-sensitive mutations in Stage IA2-IB NSCLC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['3-year Disease-free Survival']}, 'descriptionModule': {'briefSummary': 'To evaluate 3-year disease-free survival after complete resection in patients with MRD-positive EGFR-sensitive mutations in Stage IA2-IB NSCLC treated with adjuvant befortinib and under routine observation (3y-DFS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age: 18-75 years old.\n2. Gender: both men and women are acceptable, as balanced as possible.\n3. Patients with lung adenocarcinoma who underwent R0 resection and were clinically confirmed as IA2-IB by histopathology and whose tumor size was (1-4cm), the surgical tissue samples tested positive for EGFR-sensitive mutations and positive for MRD after surgery.\n4. Accompanied by arbitrary ≥ 2 high-risk factors; High risk factors such as pleural invasion, airway diffusion, vascular infiltration, low differentiation, pathological micropapillary composition ≥ 15%, complex glandular composition ≥ 20%, etc.\n\n4\\. Achieve R0 resection: For CTR \\< 50% ground glass nodules, wedge resection is acceptable and the margin is negative, and 3 groups of lymph node biopsies are negative; for CTR ≥ 50% or pure solid nodules, at least segmental resection is undergone, and lymph node dissection is systematically performed; if there is no clear evidence of metastasis, if it cannot be judged, it can be determined by an independent review committee for pathological consultation.\n\n5\\. The ECOG behavioral status score is 0 to 1, and the expected survival time is \\> 1 year.\n\n6\\. Voluntary MRD screening and voluntary befortinib adjuvant therapy; 7. Have a certain organ system function, defined as follows, based on the researcher's experience A. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L B. Platelets ≥ 100 x 109/L; C. Hemoglobin ≥ 9 g/dL (≥ 90 g/L) Note that in order to achieve the required hemoglobin level, blood transfusion is allowed; D. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); E. If there is no liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; if liver metastasis, ≤ 5 × ULN; F. Creatinine ≤ 1.5 x ULN. Patients are still eligible for inclusion if the creatinine clearance value calculated by the Cockcroft-Gault method is ≥ 50 mL/min (0.83 mL/s).\n\n8\\. Female subjects of childbearing age must have a serum pregnancy test within 3 days before the start of the study drug, and the result is negative, and they are willing to use a medically approved high-efficacy contraceptive method (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last administration of the study drug; for significant other male subjects who are women of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study period and within 3 months after the last study dose.\n\n9\\. Voluntary and capable of following the test and follow-up procedures. 10. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. There is any other treatment before the operation, and no informed consent is signed;\n2. The patient has been diagnosed with cancer within 2 years;\n3. Have a history of interstitial lung disease, drug-induced interstitial disease or any active interstitial lung disease with clinical evidence; CT scan at baseline revealed idiopathic pulmonary fibrosis.\n4. Patients who are known to be allergic to any component of befortinib or similar drugs;\n5. Pregnant or lactating women;\n6. Situations considered unsuitable for inclusion by other researchers."}, 'identificationModule': {'nctId': 'NCT06561620', 'briefTitle': 'Befotertinib Adjuvant Therapy in Stage IA2-IB NSCLC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Prospective Study of Befotertinib Adjuvant Therapy in Patients With Postoperative MRD-positive Non-small Cell Lung Cancer in Stage IA2-IB With High Risk Factors', 'orgStudyIdInfo': {'id': 'ECTOP-1024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'interventionNames': ['Drug: Befotertinib']}, {'type': 'NO_INTERVENTION', 'label': 'Observation'}], 'interventions': [{'name': 'Befotertinib', 'type': 'DRUG', 'description': 'Befotertinib is a novel, selective oral third-generation epidermal growth factor receptor tyrosine-kinase inhibitor.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Haiquan, MD', 'role': 'CONTACT', 'email': 'hqchen1@yahoo.com', 'phone': '+86-21 64175590', 'phoneExt': '1707'}], 'facility': 'Fudan University Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hang Li', 'role': 'CONTACT', 'email': 'drlihang@163.com', 'phone': '+862164175590'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of the MDT board of thoracic cancer', 'investigatorFullName': 'Haiquan Chen', 'investigatorAffiliation': 'Fudan University'}}}}