Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-27 @ 4:43 PM
Study NCT ID:
NCT05844150
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-12
First Post:
2023-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010984', 'term': 'Platinum'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-09', 'studyFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2023-04-25', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'OS is the time from the date of randomization or first dosing date to death due to any cause.'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Progression free survival (PFS) is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'DCR is defined as the proportion of subjects with CR, PR, or stable disease (SD) based on RECIST v1.1.'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'DOR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieve CR or PR (based on RECIST v1.1).'}, {'measure': 'Pharmacokinetic (PK) parameters', 'timeFrame': 'Up to 30 days after last treatment', 'description': 'The PK parameters including serum concentrations of PM8002 at different time points after study drug administration.'}, {'measure': 'Anti-drug antibody (ADA)', 'timeFrame': 'Up to 30 days after last treatment', 'description': 'To evaluate the incidence of ADA to PM8002.'}, {'measure': 'Treatment related adverse events (TRAEs)', 'timeFrame': 'Up to 30 days after last treatment', 'description': 'The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ES-SCLC'], 'conditions': ['SCLC']}, 'descriptionModule': {'briefSummary': 'PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the efficacy and safety of PM8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer', 'detailedDescription': 'The study is divided into two parts.\n\nThe first part is single-arm study, 50 participants were enrolled as of 21 Nov 2023，and recruitment was completed.\n\nThe second part is randomized, double-blind study, active controlled design , which will be integrated to another global III study （NCT06712355）.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent form before any trial-related processes;\n2. Age ≥18 years;\n3. Histologically or cytologically confirmed ES-SCLC;\n4. No prior systemic therapy for ES-SCLC;\n5. Have adequate organ function;\n6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;\n7. Life expectancy of ≥12 weeks;\n8. Had at least one measurable tumor lesion according to RECIST v1.1.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed mixed SCLC;\n2. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;\n3. The toxicity of previous anti-tumor therapy has not been alleviated；\n4. Have received anti-platelet therapy within 10 days prior to the first dose of the study drugs;\n5. Evidence and history of severe bleeding tendency;\n6. History of severe cardiovascular diseases within 6 months;\n7. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;\n8. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;\n9. History of alcohol abuse, psychotropic substance abuse or drug abuse;\n10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;\n11. Pregnant or lactating women;\n12. Other conditions considered unsuitable for this study by the investigator.'}, 'identificationModule': {'nctId': 'NCT05844150', 'briefTitle': 'A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotheus Inc.'}, 'officialTitle': 'A Phase II Clinical Trial to Evaluate the Efficacy and Safety of PM8002 in Combination With Etoposide and Platinum in First-line Treatment of Extensive-Stage Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'PM8002-BC011C-SCLC-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PM8002+Etoposide＋platinum', 'description': 'Subjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years.', 'interventionNames': ['Drug: PM8002', 'Drug: Platinum', 'Drug: Etoposide']}], 'interventions': [{'name': 'PM8002', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ['PM8002+Etoposide＋platinum']}, {'name': 'Platinum', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ['PM8002+Etoposide＋platinum']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ['PM8002+Etoposide＋platinum']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'country': 'China', 'facility': 'Jilin Cancer Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hangzhou', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Harbin', 'country': 'China', 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Hefei', 'country': 'China', 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Jinan', 'country': 'China', 'facility': 'Central Hospital Affiliated To Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Langfang', 'country': 'China', 'facility': 'Hebei Petro China Central Hospital', 'geoPoint': {'lat': 39.52079, 'lon': 116.71471}}, {'city': 'Linyi', 'country': 'China', 'facility': 'Linyi Cancer Hospital', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'city': 'Nanchang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Qingdao', 'country': 'China', 'facility': 'The Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shandong', 'country': 'China', 'facility': 'Shandong Cancer Hospital', 'geoPoint': {'lat': 40.28464, 'lon': 120.48412}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Taizhou', 'country': 'China', 'facility': 'Taizhou Hospital of Zhejiang Province', 'geoPoint': {'lat': 32.49069, 'lon': 119.90812}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Zhengzhou', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'overallOfficials': [{'name': 'Ying Cheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jilin Provincial Tumor Hospital'}]}, 'ipdSharingStatementModule': {'timeFrame': 'After the trial completed', 'ipdSharing': 'YES', 'description': 'The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations', 'accessCriteria': 'NCI is committed to sharing data in accordance with NIH policy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotheus Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}