Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-28 @ 9:17 AM
Study NCT ID:
NCT05607550
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-22
First Post:
2022-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)
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': 'C000705711', 'term': 'aflutinib'}, {'id': 'D017671', 'term': 'Platinum Compounds'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 398}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2022-11-04', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) determined by blinded independent central review (BICR)', 'timeFrame': 'Up to 32 months after first dose'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 62 months after first dose'}, {'measure': 'PFS determined by investigator assessment', 'timeFrame': 'Up to 36 months after first dose'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'Up to 36 months after first dose'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 36 months after first dose'}, {'measure': 'Time to second Progression Free Survival (PFS2)', 'timeFrame': 'Up to 36 months after first dose'}, {'measure': 'PFS by blinded independent central review (BICR) in patients with a history or presence of brain metastases at baseline', 'timeFrame': 'Up to 36 months after first dose'}, {'measure': 'Time to central nervous system (CNS) metastases by BICR', 'timeFrame': 'Randomization up to ≤30 days after last dose'}, {'measure': 'CNS ORR evaluated by BICR', 'timeFrame': 'Randomization up to ≤30 days after last dose'}, {'measure': 'CNS DOR evaluated by BICR', 'timeFrame': 'Randomization up to ≤30 days after last dose'}, {'measure': 'CNS PFS evaluated by BICR', 'timeFrame': 'Randomization up to ≤30 days after last dose'}, {'measure': 'Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)', 'timeFrame': 'Randomization up to ≤30 days after last dose', 'description': 'QLQ-C30 is a cancer-specific questionnaire comprised of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).'}, {'measure': 'Change in EORTC QLQ Lung Cancer Module Core 13 (QLQ LC13)', 'timeFrame': 'Randomization up to ≤30 days after last dose', 'description': 'QLQ-LC13 is a cancer-specific questionnaire which comprises of 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication.'}, {'measure': 'Change in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC SAQ)', 'timeFrame': 'Randomization up to ≤30 days after last dose', 'description': 'NSCLC-SAQ consists of 7 items assessing 5 NSCLC symptom concepts: cough, pain, dyspnea, fatigue, and poor appetite.'}, {'measure': 'Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib', 'timeFrame': 'Up to 36 months after first dose'}, {'measure': 'Plasma concentrations of furmonertinib and its major metabolite (AST5902)', 'timeFrame': 'Up to 36 months after first dose'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Small Cell Lung Cancer (NSCLC)', 'Exon 20', 'Furmonertinib', 'Firmonertinib', 'AST2818', 'FURMO-004', 'Drug-Therapy'], 'conditions': ['Metastatic Non-Small Cell Lung Cancer', 'Advanced Non-Small Cell Lung Cancer', 'EGFR Exon 20 Mutations']}, 'descriptionModule': {'briefSummary': 'Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib (firmonertinib) at 2 dose levels (160 mg once daily \\[QD\\] and 240 mg QD) compared to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations. A target of approximately 375 patients will be randomized in a 1:1:1 ratio to treatment with furmonertinib 240 mg QD, furmonertinib 160 mg QD, or platinum-based chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.\n* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing.\n* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).\n* Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months.\n* Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.'}, 'identificationModule': {'nctId': 'NCT05607550', 'briefTitle': 'Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ArriVent BioPharma, Inc.'}, 'officialTitle': 'A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Furmonertinib Compared to Platinum-Based Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)', 'orgStudyIdInfo': {'id': 'FURMO-004'}, 'secondaryIdInfos': [{'id': '2022-502977-41-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'furmonertinib 240 mg', 'interventionNames': ['Drug: furmonertinib 240 mg oral, daily']}, {'type': 'EXPERIMENTAL', 'label': 'furmonertinib 160 mg', 'interventionNames': ['Drug: furmonertinib 160 mg oral, daily']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'platinum-based chemotherapy', 'description': "carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously", 'interventionNames': ['Drug: platinum-based chemotherapy']}], 'interventions': [{'name': 'furmonertinib 240 mg oral, daily', 'type': 'DRUG', 'otherNames': ['AST2818'], 'description': 'furmonertinib tablet', 'armGroupLabels': ['furmonertinib 240 mg']}, {'name': 'furmonertinib 160 mg oral, daily', 'type': 'DRUG', 'otherNames': ['AST2818'], 'description': 'furmonertinib tablet', 'armGroupLabels': ['furmonertinib 160 mg']}, {'name': 'platinum-based chemotherapy', 'type': 'DRUG', 'description': "(carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)", 'armGroupLabels': ['platinum-based chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36526', 'city': 'Daphne', 'state': 'Alabama', 'country': 'United States', 'facility': 'Arrivent Investigative Site', 'geoPoint': {'lat': 30.60353, 'lon': -87.9036}}, {'zip': '85364', 'city': 'Yuma', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arrivent Investigative Site', 'geoPoint': {'lat': 32.72532, 'lon': -114.6244}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arrivent Investigative Site', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '90212', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Arrivent 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