Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-30 @ 4:57 AM
Study NCT ID:
NCT06182761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Sunvozertinib Combined With Anlotinib in Local Advanced or Metastatic Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625192', 'term': 'anlotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-26', 'studyFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2023-12-26', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'initiate from first dose until the date of confirmed response, assessed up to 24 weeks', 'description': 'Objective response rate (ORR) as assessed by the investigator according to RECIST 1.1 criteria.'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'initiate from first dose, every 6 weeks until PD or study close, an average of 1 year', 'description': 'PFS as assessed by the investigator according to RECIST 1.1'}, {'measure': 'OS', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'initiate from first dose to death from any cause'}, {'measure': 'DoR', 'timeFrame': 'an average of 1 year', 'description': 'The period from the first judgment of CR or PR to PD'}, {'measure': 'AE', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'TRAE as assessed by the investigator according to CTCAE 5.0'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NSCLC']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the efficacy and safety of treatment with sunvozertinib in combination with Anlotinib in patients whose disease has progressed following first-line EGFR-TKIs treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.\n2. Pathologically confirmed non-squamous NSCLC. Locally advanced or metastatic NSCLC\n3. EGFR sensitive mutations confirmed by accredited local laboratories， including 19del、L858R and T790M。\n4. Intolerant or refuses, or not suitable for systemic chemotherapy.\n5. Progressed after EGFR-TKI targeted therapy or are intolerant to standard treatment; if carry T790M mutation, need to be treated with osimertinib or other third-generation EGFR-TKI.\n6. World Health Organization performance status of 0 to 1\n7. Life expectancy \\>12 weeks at Day 1.\n8. At least 1 lesion to be measured\n9. Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling criteria at screening.\n10. Male patients must be willing to use barrier contraception\n\nExclusion Criteria:\n\n1. Any known RET rearrangement, BRAF V600E mutation, NTRK fusion, MET ex14 skip mutation, MET amplification (defined as tissue detection GCN ≥ 5 by NGS)\n2. Any concurrent and/or other active malignancy within 2 years\n3. Major surgery within 4 weeks of the first dose of IP\n4. Any unresolved toxicities from prior therapy.\n5. Past medical history of ILD (interstitial lung disease)/pneumonitis, drug-induced ILD/pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis\n6. Any evidence of severe or uncontrolled systemic diseases.\n7. Any of the following cardiac criteria:\n\n i) Mean resting QTc \\>470 msec ii) Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram iii) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events\n8. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of Sunvozertinib and Anlotinib\n9. Severe allergies to Sunvozertinib and Anlotinib'}, 'identificationModule': {'nctId': 'NCT06182761', 'acronym': 'WUKONG-9', 'briefTitle': 'A Study of Sunvozertinib Combined With Anlotinib in Local Advanced or Metastatic Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Efficacy and Safety of Sunvozertinib With Anlotinib in EGFR-TKIs Resistant EGFR-sensitive Mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC): a Prospective, Single-arm, Phase II Trial', 'orgStudyIdInfo': {'id': 'WUKONG9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sunvozertinib in combination with Anlotinib', 'interventionNames': ['Drug: Sunvozertinib combination with Anlotinib']}], 'interventions': [{'name': 'Sunvozertinib combination with Anlotinib', 'type': 'DRUG', 'description': 'Sunvozertinib 300 mg once daily (QD) with Anlotinib 12mg once daily （QD in Day 1-14） ，21 days in one cycle.', 'armGroupLabels': ['sunvozertinib in combination with Anlotinib']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}