Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:05 AM
Study NCT ID:
NCT07489703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'From date of first study treatment to the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to approximately 36 months.', 'description': 'Progression-free survival (PFS), defined as the time from first study treatment to disease progression or death from any cause, whichever occurs first. Disease progression is assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.'}], 'secondaryOutcomes': [{'measure': 'DOR', 'timeFrame': 'From the date of first documented objective response to the date of first documented disease progression or death from any cause prior to progression, whichever occurs first, assessed up to approximately 36 months.', 'description': 'Duration of response (DOR), defined as the time from the first documented objective response (complete response or partial response) to the first documented disease progression or death from any cause prior to progression, whichever occurs first. Objective response is assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.'}, {'measure': 'ORR', 'timeFrame': 'From first study treatment to disease progression or initiation of new anti-tumor therapy, assessed up to approximately 36 months.', 'description': 'Objective response rate (ORR), defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.'}, {'measure': 'OS', 'timeFrame': 'From date of first study treatment to date of death from any cause, assessed up to approximately 36 months.', 'description': 'Overall survival (OS), defined as the time from first study treatment to death from any cause.'}, {'measure': 'Adverse Events', 'timeFrame': 'From signing of informed consent through 90 days after the last dose of study treatment or initiation of new anti-tumor therapy, whichever occurs first.', 'description': 'Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Relationship to study treatment (SHR-A1811 and/or AK112) is assessed by the investigator.'}, {'measure': 'Serious Adverse Events', 'timeFrame': 'From signing of informed consent through 90 days after the last dose of study treatment or initiation of new anti-tumor therapy, whichever occurs first.', 'description': 'Incidence of serious adverse events (SAEs), regardless of causality, as defined in the study protocol. SAEs include events that result in death, are life-threatening, require inpatient hospitalization or prolongation of existing hospitalization, result in persistent or significant disability/incapacity, are congenital anomalies/birth defects, or are other medically important conditions.'}, {'measure': 'Treatment-Related Adverse Events', 'timeFrame': 'From first dose of study treatment through 90 days after the last dose or initiation of new anti-tumor therapy, whichever occurs first.', 'description': 'Incidence and severity of treatment-related adverse events (TRAEs), defined as adverse events assessed by the investigator as having a reasonable possibility of causal relationship to SHR-A1811 and/or AK112. Severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSCLC', 'HER2'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase II, open-label, single-arm study evaluating the efficacy and safety of SHR-A1811 (a HER2-targeted ADC) combined with AK112 (a PD-1/VEGF bispecific antibody) in patients with HER2-amplified or overexpressed locally advanced or metastatic NSCLC.', 'detailedDescription': 'The study consists of two cohorts: Cohort 1 includes patients who failed standard first-line therapy; Cohort 2 includes treatment-naïve patients. Patients will receive treatment with SHR-A1811 and AK112 until disease progression or meeting other criteria for treatment discontinuation, whichever occurs first.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed ICF.\n2. Age 18-75.\n3. ECOG PS 0-1.\n4. Life expectancy ≥3 months.\n5. Histologically/cytologically confirmed locally advanced or metastatic/recurrent NSCLC, not eligible for curative surgery or definitive chemoradiotherapy.\n6. Cohort 1: Failed prior first-line systemic therapy, with HER2 amplification or overexpression . Cohort 2: No prior systemic therapy, with HER2 amplification/overexpression .\n7. ≥1 measurable lesion per RECIST 1.1.\n8. Adequate organ and bone marrow function.\n9. Use of effective contraception.\n\nExclusion Criteria:\n\n1. History of ILD, pneumonitis requiring steroids, or active non-infectious pneumonitis.\n2. Arterial/venous thrombotic event within 6 months.\n3. Significant cardiovascular disease.\n4. Active autoimmune disease requiring systemic treatment.\n5. Use of systemic immunosuppressants within 2 weeks prior.\n6. Symptomatic pleural/pericardial/ascitic effusion requiring drainage.\n7. Symptomatic, progressive, or diffusely spread CNS metastases.'}, 'identificationModule': {'nctId': 'NCT07489703', 'briefTitle': 'SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SHR-A1811 Combined With Ivonescimab (AK112) in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With HER2 Abnormalities', 'orgStudyIdInfo': {'id': 'MA-NSCLC-II-062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Cohort 1 includes patients who failed standard first-line therapy, patients receive treatment with SHR-A1811 and AK112 until disease progression or meeting other criteria for treatment discontinuation, whichever occurs first.', 'interventionNames': ['Drug: SHR-A1811 plus AK112']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Cohort 2 includes treatment-naïve patients. Patients receive treatment with SHR-A1811 and AK112 until disease progression or meeting other criteria for treatment discontinuation, whichever occurs first.', 'interventionNames': ['Drug: SHR-A1811 plus AK112']}], 'interventions': [{'name': 'SHR-A1811 plus AK112', 'type': 'DRUG', 'description': 'Patients will receive the combination of SHR-A1811 and AK112 until disease progression or until other predefined discontinuation criteria are met, whichever occurs first.', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Li Zhang, Professor', 'role': 'CONTACT', 'email': 'zhangli@sysucc.org.cn', 'phone': '+86-20-87343289'}, {'name': 'Yan Huang, Professor', 'role': 'CONTACT', 'email': 'huangyan@sysucc.org.cn'}], 'overallOfficials': [{'name': 'Li Zhang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD sharing was not included in the informed consent form approved by the ethics committee. Therefore, sharing individual participant data would violate the ethical agreements made with study participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Li Zhang, MD', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}