Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-02 @ 12:00 AM
Study NCT ID:
NCT05209256
Status:
UNKNOWN
Last Update Posted:
2022-01-26
First Post:
2022-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'C000705711', 'term': 'aflutinib'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-25', 'studyFirstSubmitDate': '2022-01-09', 'studyFirstSubmitQcDate': '2022-01-25', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '16 weeks', 'description': 'Disease-free survival'}], 'secondaryOutcomes': [{'measure': 'Objective remission rate (ORR)', 'timeFrame': '16 weeks', 'description': 'Objective remission rate'}, {'measure': 'Disease Control Rate ( DCR)', 'timeFrame': '16 weeks', 'description': 'Disease Control Rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSCLC ，EGFR(T790M)，alflutinib'], 'conditions': ['NSCLC']}, 'referencesModule': {'references': [{'pmid': '33070053', 'type': 'BACKGROUND', 'citation': 'Garcia-Campelo R, Arrieta O, Massuti B, Rodriguez-Abreu D, Granados ALO, Majem M, Vicente D, Lianes P, Bosch-Barrera J, Insa A, Domine M, Reguart N, Guirado M, Sala MA, Vazquez-Estevez S, Caro RB, Drozdowskyj A, Verdu A, Karachaliou N, Molina-Vila MA, Rosell R; Spanish Lung Cancer Group (SLCG). Combination of gefitinib and olaparib versus gefitinib alone in EGFR mutant non-small-cell lung cancer (NSCLC): A multicenter, randomized phase II study (GOAL). Lung Cancer. 2020 Dec;150:62-69. doi: 10.1016/j.lungcan.2020.09.018. Epub 2020 Oct 3.'}, {'pmid': '33358484', 'type': 'BACKGROUND', 'citation': 'Griesinger F, Eberhardt W, Nusch A, Reiser M, Zahn MO, Maintz C, Bernhardt C, Losem C, Stenzinger A, Heukamp LC, Buttner R, Marschner N, Janicke M, Fleitz A, Spring L, Sahlmann J, Karatas A, Hipper A, Weichert W, Heilmann M, Sadjadian P, Gleiber W, Grah C, Waller CF, Reck M, Rittmeyer A, Christopoulos P, Sebastian M, Thomas M; CRISP Registry Group. Biomarker testing in non-small cell lung cancer in routine care: Analysis of the first 3,717 patients in the German prospective, observational, nation-wide CRISP Registry (AIO-TRK-0315). Lung Cancer. 2021 Feb;152:174-184. doi: 10.1016/j.lungcan.2020.10.012. Epub 2020 Nov 2.'}, {'pmid': '32854536', 'type': 'BACKGROUND', 'citation': 'Hochmair MJ, Morabito A, Hao D, Yang CT, Soo RA, Yang JC, Gucalp R, Halmos B, Marten A, Cufer T. Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: final analysis of the GioTag study. Future Oncol. 2020 Dec;16(34):2799-2808. doi: 10.2217/fon-2020-0740. Epub 2020 Aug 28.'}, {'pmid': '33316418', 'type': 'BACKGROUND', 'citation': 'Imyanitov EN, Iyevleva AG, Levchenko EV. Molecular testing and targeted therapy for non-small cell lung cancer: Current status and perspectives. Crit Rev Oncol Hematol. 2021 Jan;157:103194. doi: 10.1016/j.critrevonc.2020.103194. Epub 2020 Dec 11.'}, {'pmid': '32888648', 'type': 'BACKGROUND', 'citation': 'Kayatani H, Ohashi K, Ninomiya K, Makimoto G, Nishii K, Higo H, Watanabe H, Kano H, Kato Y, Ninomiya T, Kubo T, Rai K, Ichihara E, Hotta K, Tabata M, Maeda Y, Kiura K. Beneficial effect of erlotinib and trastuzumab emtansine combination in lung tumors harboring EGFR mutations. Biochem Biophys Res Commun. 2020 Nov 12;532(3):341-346. doi: 10.1016/j.bbrc.2020.07.055. Epub 2020 Sep 2.'}, {'pmid': '33331989', 'type': 'BACKGROUND', 'citation': 'Mok TS, Cheng Y, Zhou X, Lee KH, Nakagawa K, Niho S, Chawla A, Rosell R, Corral J, Migliorino MR, Pluzanski A, Noonan K, Tang Y, Pastel M, Wilner KD, Wu YL. Updated Overall Survival in a Randomized Study Comparing Dacomitinib with Gefitinib as First-Line Treatment in Patients with Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations. Drugs. 2021 Feb;81(2):257-266. doi: 10.1007/s40265-020-01441-6.'}, {'pmid': '33751180', 'type': 'BACKGROUND', 'citation': 'Nakahara Y, Matsutani T, Igarashi Y, Matsuo N, Himuro H, Saito H, Yamada K, Murotani K, Hoshino T, Azuma K, Sasada T. Clinical significance of peripheral TCR and BCR repertoire diversity in EGFR/ALK wild-type NSCLC treated with anti-PD-1 antibody. Cancer Immunol Immunother. 2021 Oct;70(10):2881-2892. doi: 10.1007/s00262-021-02900-z. Epub 2021 Mar 9.'}, {'pmid': '32424780', 'type': 'BACKGROUND', 'citation': 'Nakashima K, Ozawa Y, Daga H, Imai H, Tamiya M, Tokito T, Kawamura T, Akamatsu H, Tsuboguchi Y, Takahashi T, Yamamoto N, Mori K, Murakami H. Osimertinib for patients with poor performance status and EGFR T790M mutation-positive advanced non-small cell lung cancer: a phase II clinical trial. Invest New Drugs. 2020 Dec;38(6):1854-1861. doi: 10.1007/s10637-020-00943-0. Epub 2020 May 18.'}]}, 'descriptionModule': {'briefSummary': 'Aim: the aim of this study is to investigated whether the combination of alflutinib with cytotoxic chemotherapy might hold additive efficacy, as well as tolerability .', 'detailedDescription': 'alflutinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that is active in the central nervous system (CNS) and which potently and selectively inhibits mutant forms of EGFR with both TKI-sensitising (activating) mutations and the T790M resistance-conferring mutation. However, resistance to alflutinib inevitably emerges. One promising strategy to further improve patient prognosis and to approach a cure is combination therapy with alflutinib and other agents such as cytotoxic chemotherapeutic drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically or cytologically diagnosed non-squamous NSCLC of stage IIIB or IV (based on the 7th edition of the TNM classification) or recurrent;\n* an EGFR mutation, including an exon-19 deletion (Ex19del), L858R, or other (L861Q, G719A, G719C, or G719S), as well as the T790M mutation of EGFR as detected in a tissue or liquid biopsy sample obtained after disease progression during first-line EGFR-TKI (gefitinib, erlotinib, or afatinib) treatment;\n* WHO performance status of 0 or 1;\n* no prior neoadjuvant or adjuvant chemotherapy in the 12 months preceding study enrollment;\n* adequate bone marrow reserve and organ function.\n\nExclusion Criteria:\n\n* treatment with an EGFR-TKI within 7 days of the first dose of the study treatment;\n* symptomatic CNS metastases;\n* evidence of interstitial pneumonia, pulmonary fibrosis, or radiation pneumonitis requiring steroid treatment as revealed by a computed tomography (CT) scan.'}, 'identificationModule': {'nctId': 'NCT05209256', 'briefTitle': 'Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Henan University of Science and Technology'}, 'officialTitle': 'Alflutinib Versus Alflutinib Plus Chemotherapy for Nonesmall Cell Lung Cancer With EGFR (T790M)- Associated Resistance to Initial EGFR Inhibitor Treatment: An Open-label, Randomised Phase 2 Clinical Trial', 'orgStudyIdInfo': {'id': 'ALF-IN-NSCLC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alflutinib plus chemotherapy', 'description': 'Those in the combination group received concurrent alflutinib (80 mg daily), as well as carboplatin (area under the curve \\[AUC\\] of 5 on day 1) and pemetrexed (500 mg/m2 on day 1) in a 3-week cycle for up to four cycles, followed by maintenance on alflutinib and pemetrexed until disease progression, unacceptable toxicity, or death.', 'interventionNames': ['Drug: Alflutinib plus chemotherapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'chemotherapy', 'description': 'arboplatin (area under the curve \\[AUC\\] of 5 on day 1) and pemetrexed (500 mg/m2 on day 1) in a 3-week cycle for up to four cycles, followed by maintenance on alflutinib and pemetrexed until disease progression, unacceptable toxicity, or death.', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'Chemotherapy', 'type': 'DRUG', 'otherNames': ['pemetrexed', 'Pulaile'], 'description': 'Patients in the alflutinib group received alflutinib (80 mg daily) until disease progression, unacceptable toxicity, or death.', 'armGroupLabels': ['chemotherapy']}, {'name': 'Alflutinib plus chemotherapy', 'type': 'DRUG', 'otherNames': ['AST2818', 'Pulaile'], 'description': 'Those in the combination group received concurrent alflutinib (80 mg daily), as well as carboplatin (area under the curve \\[AUC\\] of 5 on day 1) and pemetrexed (500 mg/m2 on day 1) in a 3-week cycle for up to four cycles, followed by maintenance on alflutinib and pemetrexed until disease progression, unacceptable toxicity, or death.', 'armGroupLabels': ['Alflutinib plus chemotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jiachun Sun, PHD', 'role': 'CONTACT', 'email': 'sunjiachun1980@126.com', 'phone': '18638882757'}, {'name': 'Tanyou Shan, MD', 'role': 'CONTACT', 'email': 'shantanyoudoctor@163.com', 'phone': '18537976669'}], 'overallOfficials': [{'name': 'Xinshuai Wang, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology'}, {'name': 'Guoqiang Kong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology'}, {'name': 'Xiaozhi Yuan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology'}, {'name': 'Jing Ren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Henan University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}