Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 1:07 AM
Study NCT ID:
NCT07482605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D016066', 'term': 'Pleural Effusion, Malignant'}, {'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}], 'ancestors': [{'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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000705711', 'term': 'aflutinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Masking Description'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Model Description'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From date of first dose to date of first documented disease progression or death from any cause, assessed up to 24 months.', 'description': 'PFS defined as time from first dose of furmonertinib to disease progression per RECIST v1.1 or death from any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'At 3 months after completion of radiotherapy .', 'description': 'Proportion of subjects achieving complete response (CR) or partial response (PR) according to RECIST v1.1.'}, {'measure': 'Malignant Pleural Effusion Control Rate .', 'timeFrame': 'At 1, 3, and 6 months after completion of radiotherapy .', 'description': 'Proportion of subjects with controlled malignant pleural effusion (complete response + partial response) according to MPE response criteria.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'At 3 and 6 months after completion of radiotherapy', 'description': 'Proportion of subjects achieving CR, PR, or stable disease (SD) according to RECIST v1.1.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From date of first dose to date of death from any cause, assessed up to 36 months .', 'description': 'Time from first dose of furmonertinib to death from any cause.'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'From date of first dose to 30 days after last dose .', 'description': 'Frequency, severity, and relationship of adverse events assessed by CTCAE v5.0.'}, {'measure': 'Peripheral Blood ctDNA Level', 'timeFrame': '48 hours prior to the first furmonertinib treatment, 48 hours prior to the first thoracic radiotherapy, 48 hours after the completion of the last thoracic radiotherapy, and 48 hours after CT indicates disease progression.', 'description': 'Dynamic changes in circulating tumor DNA (ctDNA) concentration in peripheral blood measured by next-generation sequencing (NGS).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Furmonertinib', 'Radiotherapy', 'EGFR mutation', 'Lung adenocarcinoma'], 'conditions': ['Lung Cancer (NSCLC)', 'Malignant Pleural Effusions (Mpe)- Pleurodesis']}, 'referencesModule': {'references': [{'pmid': '37288833', 'type': 'BACKGROUND', 'citation': 'Li Q, Hu C, Su S, Ma Z, Geng Y, Hu Y, Jin H, Li H, Lu B. Impact of thoracic tumor radiotherapy on survival in non-small-cell lung cancer with malignant pleural effusion treated with targeted therapy: Propensity score matching study. Cancer Med. 2023 Jul;12(14):14949-14959. doi: 10.1002/cam4.6130. Epub 2023 Jun 8.'}, {'pmid': '39506792', 'type': 'BACKGROUND', 'citation': 'Li W, Wu P, Liang Z, Li L, Chen Y, Zhang W, Zhang H, Fang C. Efficacy and safety of tyrosine kinase inhibitors with thoracic radiotherapy for patients with oncogene-mutated non-small cell lung cancer: a meta-analysis. Radiat Oncol. 2024 Nov 6;19(1):154. doi: 10.1186/s13014-024-02538-y.'}, {'pmid': '36438852', 'type': 'BACKGROUND', 'citation': 'Hibino M, Hiranuma O, Takemura Y, Katayama Y, Chihara Y, Harada T, Fujita K, Kita T, Tamiya N, Tsuda T, Shiotsu S, Tamura Y, Aoyama T, Nakamura Y, Terashima M, Morimoto Y, Nagata K, Yoshimura K, Uchino J, Takayama K. Osimertinib and Bevacizumab Cotreatment for Untreated EGFR-Mutated NSCLC With Malignant Pleural or Pericardial Effusion (SPIRAL II): A Single-Arm, Open-Label, Phase 2 Clinical Trial. JTO Clin Res Rep. 2022 Oct 15;3(12):100424. doi: 10.1016/j.jtocrr.2022.100424. eCollection 2022 Dec.'}, {'pmid': '35650550', 'type': 'BACKGROUND', 'citation': 'Nokihara H, Ogino H, Mitsuhashi A, Kondo K, Ogawa E, Ozaki R, Yabuki Y, Yoneda H, Otsuka K, Nishioka Y. Efficacy of osimertinib in epidermal growth factor receptor-mutated non-small-cell lung cancer patients with pleural effusion. BMC Cancer. 2022 Jun 1;22(1):597. doi: 10.1186/s12885-022-09701-2.'}, {'pmid': '38226415', 'type': 'BACKGROUND', 'citation': 'Kiritani A, Amino Y, Uchibori K, Akita T, Harutani Y, Ogusu S, Tsugitomi R, Manabe R, Ariyasu R, Kitazono S, Yanagitani N, Nishio M. Efficacy of osimertinib in patients with EGFR-mutation positive non-small cell lung cancer with malignant pleural effusion. Thorac Cancer. 2024 Feb;15(5):402-409. doi: 10.1111/1759-7714.15210. Epub 2024 Jan 16.'}, {'pmid': '37274290', 'type': 'BACKGROUND', 'citation': 'Li Q, Hu C, Su S, Ma Z, Geng Y, Hu Y, Li H, Lu B. Failure pattern and radiotherapy exploration in malignant pleural effusion non-small cell lung cancer treated with targeted therapy. Front Oncol. 2023 May 19;13:974735. doi: 10.3389/fonc.2023.974735. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to prospectively and multi-centrally explore the efficacy and safety of furmonertinib combined with upfront thoracic radiotherapy in treating NSCLC participants with EGFR mutations and malignant pleural effusion, thereby providing more evidence-based medical evidence for improved diagnosis and treatment of NSCLC-MPE participants . Additionally, NGS testing of ctDNA from peripheral blood will be performed before the first furmonertinib treatment, before the first thoracic radiotherapy and after its completion, and after disease progression. This will help identify individuals who benefit from this treatment modality and investigate new resistance mechanisms to furmonertinib under the radiotherapy plus TKI combination model, ultimately serving participants better.', 'detailedDescription': 'This study plans to prospectively and multi-centrally enroll 63 participants with stage IVA non-small cell lung adenocarcinoma harboring EGFR-sensitive mutations (exon 19 deletion, exon 21 L858R mutation) and malignant pleural effusions (MPE). After initial treatment with 2 months of furmonertinib ± thoracentesis and drainage, leading to good control of malignant pleural effusion,participants will receive thoracic radiotherapy (irradiation sites include residual primary lung tumor, regional lymph node metastases, and pleural metastases). Radiation prescription: DT 4000cGy/10F, 4Gy/fraction, once daily, 5 days/week (BED=56Gy, EQD2=46.67Gy, α/β=10). Radiotherapy for bone metastases: 3000cGy/10F, 3Gy/fraction, once daily, 5 days/week. Furmonertinib will be suspended before radiotherapy, during radiotherapy, and for 3 days after completion of radiotherapy. After radiotherapy, furmonertinib maintenance will continue until disease progression or unacceptable toxicity. This study hypothesizes that this treatment modality can effectively control malignant pleural effusion, significantly improve PFS in participants(and potentially OS), and that treatment-related toxicities will be tolerable.Furthermore, by dynamically monitoring ctDNA in peripheral blood using NGS technology before the initial furmonertinib treatment, before and after the first course of thoracic radiotherapy, and after disease progression, the investigators aim to identify individuals suitable for this treatment model and uncover new resistance mechanisms to furmonertinib under the radiotherapy plus TKI combination, thereby guiding clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years but ≤ 75 years;\n2. Histologically or cytologically confirmed advanced lung adenocarcinoma;\n3. Chest CT or whole-body PET-CT indicates pleural invasion with pleural effusion, and pleural fluid cytology confirms the presence of cancer cells. After 2 months of treatment with furmonertinib ± thoracentesis drainage, malignant pleural effusion is controlled (no pleural effusion or only ≤ 100 ml of pleural effusion), and a small amount of pericardial effusion may be present;\n4. No prior history of thoracic radiotherapy or thoracic surgery;\n5. Positive for EGFR-sensitive mutations (19del/L858R);\n6. No prior systemic anti-tumor therapy;\n7. ECOG performance status 0-1, with a life expectancy of ≥ 12 weeks;\n8. At least one measurable lesion (according to RECIST 1.1);\n9. Signed informed consent obtained;\n10. No more than 3 bone metastases.\n\nExclusion Criteria:\n\n1. Complicated with interstitial pneumonia or infectious fever before treatment;\n2. Complicated with autoimmune diseases or long-term oral corticosteroid use;\n3. Prior history of thoracic radiotherapy or thoracic surgery;\n4. Complicated with severe anemia, grade 3 WBC or PLT suppression;\n5. Allergic to third-generation TKIs;\n6. Obvious respiratory symptoms, intolerant to radiotherapy;\n7. Active hepatitis B or hepatitis C infection, or currently undergoing antiviral treatment; patients with a clear history of HBV infection whose HBV DNA is at an undetectable level after previous active treatment may be enrolled;\n8. Poor control or continuous progression of pleural effusion after two consecutive months of TKI treatment;\n9. Patients with brain metastases or liver metastases.'}, 'identificationModule': {'nctId': 'NCT07482605', 'briefTitle': 'Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion', 'organization': {'class': 'OTHER', 'fullName': 'Jiangmen Central Hospital'}, 'officialTitle': 'A Prospective, Multicenter Study on the Safety and Efficacy of Furmonertinib Combined With Local Chest Radiotherapy in EGFR+ Non-small Cell Lung Adenocarcinoma Patients With Malignant Pleural Effusion', 'orgStudyIdInfo': {'id': '2025 312 号 B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'Patients receive furmonertinib combined with upfront thoracic radiotherapy. Furmonertinib is paused during the radiotherapy period and resumed after completion until disease progression.', 'interventionNames': ['Drug: Furmonertinib', 'Radiation: Thoracic Radiotherapy (TRT)']}], 'interventions': [{'name': 'Furmonertinib', 'type': 'DRUG', 'description': '80mg orally once daily, administered continuously except during the radiotherapy window.', 'armGroupLabels': ['experimental']}, {'name': 'Thoracic Radiotherapy (TRT)', 'type': 'RADIATION', 'description': 'Radiotherapy targeting residual primary tumor, regional lymph nodes, and pleural metastases (40Gy/10Fx) and bone metastases (30Gy/10Fx).', 'armGroupLabels': ['experimental']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangmen Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of the Oncology Department', 'investigatorFullName': 'Lin Xiao', 'investigatorAffiliation': 'Jiangmen Central Hospital'}}}}