Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-11 @ 7:48 AM
Study NCT ID:
NCT06709859
Status:
RECRUITING
Last Update Posted:
2025-07-17
First Post:
2024-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC
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': 'D000077716', 'term': 'Afatinib'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-11-26', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of NSCLC converting to resectable tumors', 'timeFrame': 'Up to 12 weeks', 'description': 'The proportion of unresectable NSCLC patients who are converted to being suitable for surgery after 3-4 cycles afatinib plus chemotherapy.'}], 'secondaryOutcomes': [{'measure': 'R0 resection rate', 'timeFrame': 'immediately after the surgery', 'description': 'The proportion of R0 resection in patients who receive surgery'}, {'measure': 'Major pathologic response (MPR) Rate', 'timeFrame': 'Up to 12 weeks', 'description': 'The proportion of patients who achieve MRP among those receiving surgery'}, {'measure': 'Pathologic complete response (pCR) Rate', 'timeFrame': 'Up to 12 weeks', 'description': 'The proportion of patients who achieve pCR among those receiving surgery'}, {'measure': 'Tumor downstaging rate', 'timeFrame': 'Up to 12 weeks', 'description': 'The proportion of patients who reach the successful downstaging criteria for NSCLC'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to five years', 'description': 'The proportion of patients who have a complete response (CR) or partial response (PR).'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Up to five years', 'description': 'The proportion of patients who have a best overall response of CR, PR, or stable disease (SD).'}, {'measure': 'Event-free survival (EFS)', 'timeFrame': 'Up to five years', 'description': 'The length of time after initial administration the patient remains free of recurrence/progression or death, whatever the cause.'}, {'measure': 'The 2-year progression-free survival (PFS) rate', 'timeFrame': 'Up to two years', 'description': 'The proportion of patients who are event-free.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to five years', 'description': 'The length of time after initial administration the patient remains alive'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Conversion Therapy', 'Afatinib'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.', 'detailedDescription': 'This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.\n\nThe primary endpoint was the rate of NSCLC converting to resectable tumors. The secondary endpoints included R0 resection rate, major pathological response (MPR) rate, pathological complete response (pCR) rate, tumor downstaging rate, objective response rate (ORR), disease control rate (DCR), 1-year event-free survival (EFS) rate, EFS and overall survival (OS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologically or cytologically confirmed diagnosis of unresectable Stage III non-small cell lung cancer as judged by the investigator.\n* Tissue or blood samples tested and confirmed to be positive for EGFR sensitive mutation\n* ECOG Performance Status of 0-1\n* At least one measurable lesion according to RECIST 1.1\n* Adequate organ and marrow function\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed combined SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcoma-like carcinoma\n* The presence of malignant pleural effusion\n* Prior systemic anti-cancer therapy for non-small cell lung cancer\n* Prior local radiotherapy for NSCLC\n* Patients with uncontrolled gastrointestinal diseases that may affect the absorption of test drugs (such as Crohn's disease, ulcerative colitis, absorption disorders, or diarrhea of any cause ≥ Grade 2 CTCAE) according to the investigator's assessment"}, 'identificationModule': {'nctId': 'NCT06709859', 'briefTitle': 'Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Shandong Public Health Clinical Center'}, 'officialTitle': 'A Phase II Trial to Evaluate the Efficacy and Safety of Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'GWLCZXEC2024-56-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Afatinib plus chemotherapy', 'description': 'Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment (afatinib 40mg qd; carboplatin (AUC 5) on day 1, and pemetrexed (500 mg/m2 for non-squamous carcinoma) or nab-paclitaxel (260 mg/m2 for squamous carcinoma) d1 q3w), and then surgery will be provided for patients who are suitable for primary tumor resection. Maintenance treatment with afatinib 40mg qd will continue up to 2 years or disease progression after surgery.', 'interventionNames': ['Drug: Afatinib plus chemotherapy as conversion treatment']}], 'interventions': [{'name': 'Afatinib plus chemotherapy as conversion treatment', 'type': 'DRUG', 'description': 'Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment, and then surgery will be provided for patients who are suitable for primary tumor resection.', 'armGroupLabels': ['Afatinib plus chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250000', 'city': 'Jinan', 'state': 'Shangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'hua zhang', 'role': 'CONTACT', 'email': '95192789@qq.com', 'phone': '0531-83347512'}], 'facility': 'Shandong Public Health Clinical Center', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Hua Zhang, PhD', 'role': 'CONTACT', 'email': '95192789@qq.com', 'phone': '0531-83347512'}], 'overallOfficials': [{'name': 'Hua Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Public Health Clinical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Public Health Clinical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}