Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-17 @ 5:34 AM
Study NCT ID:
NCT07241767
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT (Dose-limiting toxicity)：Severe toxicity occurred 21 or 28 days after each subject received their first systemic anticancer treatment.', 'timeFrame': '21or28 days after the first administration of each subject'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'from first dose to disease progression or death, up to 3 years.'}, {'measure': 'RP2D (Recommended Phase II Dose)：This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics.', 'timeFrame': 'from first dose to disease progression or death, up to 3 years', 'description': 'This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics.'}, {'measure': 'ORR (Objective Response Rate)', 'timeFrame': 'from first dose to disease progression or death, whichever comes first, up to 3 years', 'description': 'The proportion of patients whose tumor volume shrank to the pre-defined standard (complete or partial response) after treatment.'}], 'secondaryOutcomes': [{'measure': 'Duration of response (DoR)', 'timeFrame': 'from first dose to disease progression or death, whichever comes first, up to 3 years'}, {'measure': 'disease control rate (DCR)', 'timeFrame': 'from first dose to disease progression or death, whichever comes first, up to 3 years'}, {'measure': 'progression free survival (PFS)', 'timeFrame': 'from first dose to disease progression or death, whichever comes first, up to 3 years'}, {'measure': 'overall survival (OS)', 'timeFrame': 'from first dose to disease progression or death, whichever comes first, up to 3 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in combination with other anti-tumor treatments in lung cancer subjects, and determine the recommended dose (RP2D) and initial efficacy for phase II clinical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age range: 18-75 years old (including both ends), gender is not limited.\n2. Subjects with locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology as unsuitable for radical surgery or radiotherapy treatment\n3. ECOG score is 0 or 1\n4. Expected survival period ≥ 12 weeks\n5. According to the RECIST v1.1 standard, there must be at least one measurable lesion.\n6. Good level of organ function\n7. The patient voluntarily joined this study and signed informed consent\n8. Left ventricular ejection fraction (LVEF) ≥ 50%\n\nExclusion Criteria:\n\n1. Suffering from other malignant tumors within the past 5 years\n2. Subjects with active central nervous system (CNS) tumor metastasis, a history of meningeal metastasis, or current meningeal metastasis\n3. Patients with uncontrollable tumor related pain\n4. Has serious cardiovascular and cerebrovascular diseases\n5. Significant clinically significant bleeding symptoms occurred within 3 months prior to the first study medication\n6. Uncontrollable third interstitial fluid accumulation within 2 weeks of initial study medication\n7. History of clinically significant pulmonary diseases\n8. Receive other anti-tumor treatments within 4 weeks before the first medication\n9. Severe infection within 4 weeks before the first medication\n10. Active, known or suspected autoimmune diseases, and a history of autoimmune diseases.\n11. History of immunodeficiency\n12. Individuals with active pulmonary tuberculosis infection within the year prior to enrollment\n13. Chest radiation therapy patients who received\\>30 Gy within 24 weeks prior to the first use of the investigational drug\n14. The adverse reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade I\n15. Surgical treatment of important organs within 4 weeks prior to the first use of medication\n16. Use attenuated live vaccine within 28 days prior to the first use of the investigational drug\n17. There are other serious physical or mental illnesses or laboratory abnormalities present\n18. Pregnant, lactating women, or female participants who plan to become pregnant within 14 months after the last use of the investigational drug during the study period\n19. Having bleeding tendency, high risk of bleeding, coagulation dysfunction or thrombophilia tendency\n20. Previously experienced hypertensive crisis or hypertensive encephalopathy\n21. Suffering from significant vascular disease within 6 months prior to the first use of medication\n22. Have undergone a biopsy or other minor surgery within 7 days prior to the first use of medication\n23. Having severe, unhealed wounds, active ulcers, or untreated fractures\n24. Gastrointestinal perforation occurred within 6 months prior to the first use of medication\n25. 24-hour proteinuria quantification ≥ 1g within 7 days before the first medication\n26. CT/MRI indicates tumor surrounding or invading large blood vessels'}, 'identificationModule': {'nctId': 'NCT07241767', 'briefTitle': 'A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'An Open Label, Multicenter Phase II Clinical Study on the Safety, Tolerability, and Efficacy of FH-006 Injection Combined With Other Anti-tumor Therapies in Lung Cancer Subjects', 'orgStudyIdInfo': {'id': 'FH-006-201-LC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'interventionNames': ['Drug: FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Part B', 'interventionNames': ['Drug: FH-006 ; SHR-1316 ; BP102']}], 'interventions': [{'name': 'FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin', 'type': 'DRUG', 'description': 'FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin', 'armGroupLabels': ['Part A']}, {'name': 'FH-006 ; SHR-1316 ; BP102', 'type': 'DRUG', 'description': 'FH-006 ; SHR-1316 ; BP102', 'armGroupLabels': ['Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiaouxe Pi', 'role': 'CONTACT', 'email': 'Xiaoxue.pi@hengrui.com', 'phone': '0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}