Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT06179069
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2023-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of ZL-1310 in Subjects With Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2023-12-07', 'studyFirstSubmitQcDate': '2023-12-19', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Dose Limiting Toxicities of ZL-1310 as a single agent (Part 1A), in combination with Atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C)', 'timeFrame': 'up to 24 months', 'description': 'Number of subjects with Dose Limiting Toxicities (DLTs)'}, {'measure': 'Incidence of Treatment Emergent Adverse-Events of ZL-1310 as a single agent (Part 1A), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C)', 'timeFrame': 'up to 24 months', 'description': 'Number of subjects with treatment-emergent adverse events (TEAEs)'}, {'measure': 'Incidence of Serious Adverse Events of ZL-1310 as a single agent (Part 1A), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C)', 'timeFrame': 'up to 24 months', 'description': 'Number of subjects with serious adverse events'}, {'measure': 'Incidence of Treatment Emergent Adverse Events of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3) and in combination with atezolizumab and carboplatin (Part 4)', 'timeFrame': 'up to 24 months', 'description': 'Number of subjects with treatment emergent adverse events leading to dose modifications and/or study treatment discontinuation'}, {'measure': 'Incidence of Serious Adverse-Events (SAEs) of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3), and in combination with atezolizumab and carboplatin (Part 4)', 'timeFrame': 'up to 24 months', 'description': 'Number of subjects with serious adverse events'}, {'measure': "Antitumor activity per RECIST v1.1 by investigator's assessment of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3), and in combination with atezolizumab and carboplatin (Part 4)", 'timeFrame': 'up to 24 months', 'description': "antitumor activity per RECIST v1.1 by investigator's assessment"}, {'measure': 'Objective response rate (ORR) per RECIST v1.1 of ZL-1310 as a single agent (Part 2) and in combination with atezolizumab and carboplatin (Part 4)', 'timeFrame': 'up to 24 months', 'description': 'objective response rate per RECIST v1.1'}, {'measure': 'Disease control rate (DCR) per RECIST v1.1 of ZL-1310 in combination with atezolizumab', 'timeFrame': 'up to 24 months', 'description': 'disease control rate per RECIST v1.1'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR) per RECIST 1.1 of ZL-1310 as a single agent (Part 1A) in combination with atezolizumab (Part 1B), in combination with atezolizumab and carboplatin (Part 1C, Part 3)', 'timeFrame': 'up to 24 months', 'description': 'Objective Response Rate (ORR) per RECIST 1.1'}, {'measure': 'Disease control rate (DCR) per RECIST v1.1 of ZL-1310 as a single agent (Part 1A and Part 2), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 4)', 'timeFrame': 'up to 24 months', 'description': 'Disease control rate (DCR) per RECIST v1.1'}, {'measure': 'Duration of response per RECIST v1.1', 'timeFrame': 'up to 24 months', 'description': 'Duration of response per RECIST v1.1'}, {'measure': 'Progression free survival per RECIST v1.1', 'timeFrame': 'up to 24 months', 'description': 'Progression free survival per RECIST v1.1'}, {'measure': 'Overall Survival of ZL-1310', 'timeFrame': 'up to 24 months', 'description': 'Overall Survival of ZL-1310'}, {'measure': 'Pharmacokinetics: Total Antibody of ZL-1310', 'timeFrame': 'up to 24 months', 'description': 'Pharmacokinetics: Total Antibody of ZL-1310'}, {'measure': 'Pharmacokinetics: Unconjugated payloads of ZL-1310', 'timeFrame': 'up to 24 months', 'description': 'Pharmacokinetics: Unconjugated payloads of ZL-1310'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SCLC']}, 'descriptionModule': {'briefSummary': 'An open-label, multicenter study of ZL-1310 as a single agent and in combination with Atezolizumab (with and without Carboplatin) to evaluate the safety, efficacy, and pharmacokinetics in subjects with small cell lung cancer', 'detailedDescription': 'This is an open-label, ascending, multiple-dose, phase 1 study evaluating ZL-1310 as a single agent, in combination with Atezolizumab, and in combination with Atezolizumab and Carboplatin in subjects with extensive SCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Participant with metastatic or extensive-stage small cell lung cancer (de novo, not transformed) and for Part 1A and 1B must have documented disease progression during or following a platinum-based chemotherapy regimen. For Part 1C and Part 4, no prior systemic treatment for SCLC (including chemoradiotherapy for limited-stage SCLC). For Part 1B backfill, first-line setting: no prior systemic treatment for SCLC (including chemoradiotherapy for limited-stage SCLC); or, first-line maintenance setting: participants have received at least 4 cycles of 1L induction therapy with carboplatin or cisplatin, etoposide, and anti-PD-L1 inhibitor for ES-SCLC with ongoing CR, PR, or SD per RECIST v1.1 assessed by the investigator. For Part 3, participants have received at least 4 cycles of 1L induction therapy with carboplatin or cisplatin etoposide, and anti-PD-L1 inhibitor for ES-SCLC with ongoing CR, PR, or SD per RECIST v1.1 assessed by the investigator.\n* Adult men and women ≥18 years of age.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Subjects must have at least one measurable target lesion as defined by RECIST v1.1 on CT, PET/CT, or MRI.\n* Subjects must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample at screening per protocol guidelines.\n* Life Expectancy \\>/= 3 months.\n\nExclusion Criteria:\n\n* Participants with another known malignancy that is progressing or requires active treatment within the last 2 years. Exceptions: basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin with previously administered curative treatment, in situ cervical cancer, or other cancers that do not require systemic anti-cancer therapies and will not impact life expectancy.\n* Symptomatic or untreated brain metastasis requiring concurrent treatment. For Part 2, Part 3, and Part 4 the following subjects can be enrolled if they have a stable neurologic status for at least 2 weeks prior to the first dose of ZL-1310:\n\n 1. Subjects with untreated and asymptomatic brain metastases.\n 2. Subjects with treated brain metastases that are no longer symptomatic (i.e. without neurologic signs or symptoms), who require no treatment with steriods or anticonvulsants and have recovered from the actue toxic effects of radiotherapy.\n* Subjects with leptomeningeal disease.\n* Treatment with any systemic anti-cancer treatment or other investigational products/ device within 3 weeks before first dose of study treatment.\n* Non-palliative radiotherapy within 2 weeks prior to first dose of study treatment or have had a history of radiation pneumonitis.\n* Major surgery within 4 weeks of the first dose of study treatment.\n* Hypersensitivity to any ingredient of the study treatment.\n* Inadequate organ function (as defined in protocol) within 10 days prior to the first dose of study treatment,\n* Participants with a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer.\n* Participants have received a live or live-attenuated vaccine within 30 days of planned start of study therapy.\n* Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment\n* Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders, including but not limited to pneumonitis.\n* Pregnant or nursing (lactating) women.\n* Participants who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first study treatment, whichever is longer.\n* For Part 1C and Part 4 (ZL-1310 in combination with Atezolizumab and Carboplatin), participants who received prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies.\n* For Part 1B (ZL-1310 in combination with Atezolizumab) and Part 1C (ZL-1310 in combination with Atezolizumab and Carboplatin), participants who received systemic immunostimulatory agents (including but not limited to, IFNs and IL2) within 4 weeks or 5 drug-elimination half-lives, whichever is longer, prior to the initiation of study treatment.'}, 'identificationModule': {'nctId': 'NCT06179069', 'briefTitle': 'A Study of ZL-1310 in Subjects With Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zai Lab (Hong Kong), Ltd.'}, 'officialTitle': 'An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Efficacy, and Pharmacokinetics in Participants With Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'ZL-1310-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation: Part 1A', 'description': 'ZL-1310 as a single-agent', 'interventionNames': ['Drug: ZL-1310']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion: Part 1B', 'description': 'ZL-1310 in combination with Atezolizumab', 'interventionNames': ['Drug: ZL-1310', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation: Part 1C', 'description': 'ZL-1310 in combination with Atezolizumab and Carboplatin as induction and followed by ZL-1310 and Atezolizumab as maintenance', 'interventionNames': ['Drug: ZL-1310', 'Drug: Atezolizumab', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion: Arm 1 (Part 2)', 'description': 'Dose level 1 of ZL-1310 established from single-agent dose-escalation', 'interventionNames': ['Drug: ZL-1310']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion: Arm 2 (Part 2)', 'description': 'Dose level 2 of ZL-1310 established from single-agent dose escalation', 'interventionNames': ['Drug: ZL-1310']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Extension: Arm 1 (Part 2)', 'description': 'ZL-1310 as a single agent', 'interventionNames': ['Drug: ZL-1310']}, {'type': 'EXPERIMENTAL', 'label': 'Doublet Dose Optimization: Arm 1 (Part 3)', 'description': 'Dose level 1 of ZL-1310 established from single agent dose escalation, in combination with Atezolizumab', 'interventionNames': ['Drug: ZL-1310', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Doublet Dose Optimization: Arm 2 (Part 3)', 'description': 'Dose level 2 of ZL-1310 established from single agent dose escalation in combination with Atezolizumab', 'interventionNames': ['Drug: ZL-1310', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Triplet Dose Optimization: Arm 1 (Part 4)', 'description': 'Dose level 1 of ZL-1310 established from single agent dose escalation in combination with Atezolizumab + Carboplatin induction followed by ZL-1310 + Atezolizumab as maintenance', 'interventionNames': ['Drug: ZL-1310', 'Drug: Atezolizumab', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Triplet Dose Optimization: Arm 2 (Part 4)', 'description': 'Dose level 2 of ZL-1310 established from single agent dose escalation, in combination with Atezolizumab + Carboplatin induction followed by ZL-1310 + atezolizumab as induction', 'interventionNames': ['Drug: ZL-1310', 'Drug: Atezolizumab', 'Drug: Carboplatin']}], 'interventions': [{'name': 'ZL-1310', 'type': 'DRUG', 'description': 'Drug: ZL-1310', 'armGroupLabels': ['Dose Escalation: Part 1A', 'Dose Escalation: Part 1C', 'Dose Expansion: Arm 1 (Part 2)', 'Dose Expansion: Arm 2 (Part 2)', 'Dose Expansion: Part 1B', 'Dose Extension: Arm 1 (Part 2)', 'Doublet Dose Optimization: Arm 1 (Part 3)', 'Doublet Dose Optimization: Arm 2 (Part 3)', 'Triplet Dose Optimization: Arm 1 (Part 4)', 'Triplet Dose Optimization: Arm 2 (Part 4)']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'description': 'Drug Atezolizumab', 'armGroupLabels': ['Dose Escalation: Part 1C', 'Dose Expansion: Part 1B', 'Doublet Dose Optimization: Arm 1 (Part 3)', 'Doublet Dose Optimization: Arm 2 (Part 3)', 'Triplet Dose Optimization: Arm 1 (Part 4)', 'Triplet Dose Optimization: Arm 2 (Part 4)']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Drug Carboplatin', 'armGroupLabels': ['Dose Escalation: Part 1C', 'Triplet Dose Optimization: Arm 1 (Part 4)', 'Triplet Dose Optimization: Arm 2 (Part 4)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 2005', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 2005', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 2030', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 2030', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 2026', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 2026', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 2013', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 2013', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 2001', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 2001', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 2002', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 2002', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 2018', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 2018', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 2024', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 2024', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 2029', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 2029', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 2012', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 2012', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 2006', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 2006', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '230022', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1004', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1004', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1005', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1005', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '361000', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1012', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1012', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '510030', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1001', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1001', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '150000', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1009', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1009', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1006', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1006', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1002', 'role': 'CONTACT'}], 'facility': 'Zai Lab 1002', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1014', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1014', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1016', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1016', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1003', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1003', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '130012', 'city': 'Ch’ang-ch’un', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1008', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1008', 'geoPoint': {'lat': 42.74694, 'lon': 126.24667}}, {'zip': '110041', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1017', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1017', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1015', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1015', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '250000', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1011', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1011', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1010', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1010', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichaun', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 1013', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 1013', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '8035', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site: 8002', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 8002', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site: 8003', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 8003', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site: 8006', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 8006', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41009', 'city': 'Seville', 'state': 'Sevilla', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site: 8005', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 8005', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46010', 'city': 'Valencia', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site: 8004', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 8004', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site: 8001', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 8001', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '08023', 'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site: 8007', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 8007', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28050', 'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site: 8009', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 8009', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site: 8008', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 8008', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '28223', 'city': 'Pozuelo de Alarcón', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site: 8010', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 8010', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'zip': '41013', 'city': 'Seville', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site: 8011', 'role': 'CONTACT'}], 'facility': 'Zai Lab Site 8011', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Yun Wang', 'role': 'CONTACT', 'email': 'Study-ZL-1310-001@zailaboratory.com', 'phone': '8579713465'}, {'name': 'Mona Qureshi', 'role': 'CONTACT', 'email': 'Study-ZL-1310-001@zailaboratory.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zai Lab (Shanghai) Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Zai Lab (US) LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}