Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-28 @ 10:08 PM
Study NCT ID:
NCT04952168
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2021-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable 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': 'C000718108', 'term': 'aumolertinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-06-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-04', 'studyFirstSubmitDate': '2021-06-27', 'studyFirstSubmitQcDate': '2021-07-04', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year overall survival rate', 'timeFrame': '2 years', 'description': 'The 2-year overall survival rate was defined as the rate of death within 2 years'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '3 years', 'description': 'From the first treatment to the date of first documentation of disease progression, or death due to any cause'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'From the first administration to death from any cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Almonertinib', 'chemoradiotherapy'], 'conditions': ['NSCLC, Stage III']}, 'descriptionModule': {'briefSummary': 'This is a Prospective, open, single arm study to evaluate the efficacy and safety of the almonertinib combined with concurrent chemoradiotherapy in unresectable stage III NSCLC with EGFR mutation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18, male or female.\n2. Patients must provide written informed consent to participate in the study.\n3. Patients must have biopsy proven unresectable stage III NSCLC (AJCC 8th).\n4. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R).\n5. Patients receiving almonertinib for 3 months and achieved stable disease, partial response or completely response.\n6. ECOG score 0-1\n7. Demonstrate adequate organ function Patients evaluated as Cr, PR and SD were given concurrent chemoradiotherapy 3 months after targeted therapy\n\nExclusion Criteria:\n\n1. Patients progress in 3 months after almonertinib treatment\n2. Patient can't tolerate radiotherapy or targeted therapy\n3. Pregnant or nursing women"}, 'identificationModule': {'nctId': 'NCT04952168', 'briefTitle': 'Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'A Single Arm, Prospective, Open Clinical Study of Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC With EGFR Mutation', 'orgStudyIdInfo': {'id': 'TJHCC-ACLC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Almonertinib group', 'description': 'All patients were treated with Almonertinib 110 mg once a day for 3 months. Patients evaluated as CR, PR and SD were given concurrent chemoradiotherapy. The dose of radiotherapy was 60-66Gy/30-33F, After the end of concurrent chemoradiotherapy, the patients were treated with 110 mg of ametinib once a day until the disease progressed or the side effects were intolerable.', 'interventionNames': ['Drug: Almonertinib']}], 'interventions': [{'name': 'Almonertinib', 'type': 'DRUG', 'description': 'All patients were treated with Almonertinib 110 mg once a day for 3 months. Patients evaluated as CR, PR and SD were given concurrent chemoradiotherapy. The dose of radiotherapy was 60-66Gy/30-33F, After the end of concurrent chemoradiotherapy, the patients were treated with 110 mg of ametinib once a day until the disease progressed or the side effects were intolerable.', 'armGroupLabels': ['Almonertinib group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ping Peng, PhD', 'role': 'CONTACT', 'email': 'pengpingtj@163.com', 'phone': '13429818576'}], 'facility': 'Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'yuan Chen, MD', 'role': 'CONTACT', 'email': 'chenyuan008@163.com', 'phone': '00862783663407'}, {'name': 'ping Peng, PhD', 'role': 'CONTACT', 'email': 'pengpingtj@163.com', 'phone': '00862783663407'}], 'overallOfficials': [{'name': 'yuan Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuan Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of chest oncology, Professor', 'investigatorFullName': 'Yuan Chen', 'investigatorAffiliation': 'Tongji Hospital'}}}}