Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT07175220
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects
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': 'C000723862', 'term': 'SHR-1701'}]}}, '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': '2025-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-09-09', 'studyFirstSubmitQcDate': '2025-09-09', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT', 'timeFrame': '21days after the first administration of each subject'}, {'measure': 'AE', 'timeFrame': 'from Day1 to 30 days after last dose'}, {'measure': 'Incidence and severity of serious adverse events (SAE)', 'timeFrame': 'from Day1 to 30 days after last dose'}, {'measure': 'ORR', 'timeFrame': 'from first dose to disease progression or death, whichever comes first, up to 3 years'}], 'secondaryOutcomes': [{'measure': 'Immunogenic indicators: anti-SHR-A2102 antibody (ADA)', 'timeFrame': 'through study completion, an average of 2 years'}, {'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': ['Locally Advanced or Metastatic Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Evaluate the safety, tolerability, and objective response rate (ORR) of SHR2554 tablets in combination with other anti-tumor treatments in subjects with locally advanced or metastatic non-small cell lung cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age range of 18-75 years old (including both ends), gender not limited;\n2. Patients with locally advanced unresectable or metastatic non-small cell lung cancer diagnosed by pathology\n3. ECOG score is 0 or 1\n4. Expected survival period ≥ 12 weeks\n5. Has a good level of organ function\n6. Patients voluntarily joined the study and signed informed consent\n\nExclusion Criteria:\n\n1. Having difficulty swallowing or malabsorption syndrome or any other uncontrolled gastrointestinal disease (such as nausea, diarrhea, or vomiting), having undergone gastrectomy or gastric banding surgery, etc\n2. Symptomatic or active central nervous system tumor metastasis\n3. Previously or simultaneously suffering from other malignant tumors\n4. Spinal cord compression that cannot be cured by surgery and/or radiotherapy\n5. Accompanied by uncontrolled tumor related pain\n6. Plan to receive any other anti-tumor treatment during this trial period\n7. Receive other anti-tumor treatments within 4 weeks before the first medication\n8. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration\n9. Currently participating in other clinical studies or taking medication for the first time less than 4 weeks after the end of the previous clinical study\n10. Moderate to severe pleural effusion with clinical symptoms\n11. Individuals with active pulmonary tuberculosis infection within one year prior to the first use of medication\n12. Subjects who have experienced severe infections within 30 days prior to their first medication use\n13. Administer attenuated live vaccine within 30 days before the first use of medication.\n14. History of immunodeficiency\n15. Suffering from poorly controlled or severe cardiovascular and cerebrovascular diseases\n16. History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past\n17. AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1\n18. Untreated active hepatitis\n19. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n20. There are other serious physical or mental illnesses or laboratory abnormalities present'}, 'identificationModule': {'nctId': 'NCT07175220', 'briefTitle': 'Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Multicenter, Open Label Phase II Clinical Study on the Safety, Tolerability, and Efficacy of SHR2554 Tablets in Combination With Other Anti-tumor Treatments in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'SHR2554-203-LC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Queue A', 'interventionNames': ['Drug: SHR2554; SHR-A2102']}, {'type': 'EXPERIMENTAL', 'label': 'Queue B', 'interventionNames': ['Drug: SHR2554; Adabelimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Queue C', 'interventionNames': ['Drug: SHR2554; SHR-1701']}], 'interventions': [{'name': 'SHR2554; SHR-A2102', 'type': 'DRUG', 'description': 'SHR2554 tablets combined with SHR-A2102 for injection, with a cycle of 21 days', 'armGroupLabels': ['Queue A']}, {'name': 'SHR2554; Adabelimumab', 'type': 'DRUG', 'description': 'SHR2554 tablets combined with Adabelimumab, with a cycle of 21 days', 'armGroupLabels': ['Queue B']}, {'name': 'SHR2554; SHR-1701', 'type': 'DRUG', 'description': 'SHR2554 tablets combined with SHR-1701 injection, with a cycle of 21 days', 'armGroupLabels': ['Queue C']}]}, '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': 'Xiaoxue 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'}}}}