Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-30 @ 2:51 PM
Study NCT ID:
NCT07061535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'C000632826', 'term': 'sintilimab'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'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'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Tafolecimab combined with Sintilimab and Chemotherapy as the first-line treatment regimen'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival as Assessed by RECIST v1.1', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': "Progression-free survival (PFS) refers to the period from the start of combined treatment until any objectively recorded tumor progression occurs or until the patient's death (for patients lost to follow-up, it is the last follow-up time; for patients still alive at the end of the study, it is the date of the follow-up termination) as assessed by RECIST v1.1."}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate as Assessed by RECIST v1.1', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'Objective response rate (ORR) refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained that state for a certain period of time, including cases of complete response (CR) and partial response (PR) as assessed by RECIST v1.1.'}, {'measure': 'Progression-free Survival Rate as Assessed by RECISIT v1.1', 'timeFrame': 'From enrollment to the end of treatment at 6 months and 12 months', 'description': '6-month and 12-month progression-free survival rate refers to the proportion of patients whose time from the start of treatment to any objectively recorded tumor progression or patient death is equal to or greater than 6 months and 12 months.'}, {'measure': 'Overall Survival Rate as Assessed by RECISIT v1.1', 'timeFrame': 'From enrollment to the end of treatment at 12 months and 24 months', 'description': '12-month and 24-month overall survival rate refers to the proportion of patients whose time from the first administration of the drug to any cause of death was greater than or equal to 12 months and 24 months.'}, {'measure': 'Disease Control Rate as Assessed by RECISIT v1.1', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'Disease control rate refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained that state for a certain period of time. It includes cases of complete response (CR), partial response (PR), and stable disease (SD).'}, {'measure': 'Duration of Response as Assessed by RECISIT v1.1', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': "Duration of response refers to the duration from the time when the patient's condition is first confirmed as response (CR or PR) until the first record of progressive disease (PD) or death due to any reason (whichever occurs first)."}, {'measure': 'Percentage of Participants with Treatment-Related Adverse Events as Assessed by NCI-CTCAE v5.0', 'timeFrame': 'From enrollment to the end of treatment at 12 months'}, {'measure': 'Overall survival as Assessed by RECISIT v1.1', 'timeFrame': 'From enrollment to the end of treatment at 24 months', 'description': 'The time period from the first administration of the drug until death due to any cause (for patients who were lost to follow-up, it is the last follow-up time; for patients who were still alive at the end of the study, it is the date of the follow-up conclusion).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tafolecimab', 'Sintilimab', 'immunotherapy', 'PCSK9 inhibitor', 'SCLC'], 'conditions': ['Extensive-stage Small Cell Lung Cancer (ES-SCLC)', 'Extensive Stage Lung Small Cell Cancer', 'Extensive-Stage Small-Cell Lung Cancer', 'Extensive Disease Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '38630789', 'type': 'BACKGROUND', 'citation': 'Zugazagoitia J, Osma H, Baena J, Ucero AC, Paz-Ares L. Facts and Hopes on Cancer Immunotherapy for Small Cell Lung Cancer. Clin Cancer Res. 2024 Jul 15;30(14):2872-2883. doi: 10.1158/1078-0432.CCR-23-1159.'}, {'pmid': '39657676', 'type': 'BACKGROUND', 'citation': 'Mei W, Faraj Tabrizi S, Godina C, Lovisa AF, Isaksson K, Jernstrom H, Tavazoie SF. A commonly inherited human PCSK9 germline variant drives breast cancer metastasis via LRP1 receptor. Cell. 2025 Jan 23;188(2):371-389.e28. doi: 10.1016/j.cell.2024.11.009. Epub 2024 Dec 9.'}, {'pmid': '33177715', 'type': 'BACKGROUND', 'citation': 'Liu X, Bao X, Hu M, Chang H, Jiao M, Cheng J, Xie L, Huang Q, Li F, Li CY. Inhibition of PCSK9 potentiates immune checkpoint therapy for cancer. Nature. 2020 Dec;588(7839):693-698. doi: 10.1038/s41586-020-2911-7. Epub 2020 Nov 11.'}, {'pmid': '38516099', 'type': 'BACKGROUND', 'citation': 'Ma S, He Z, Liu Y, Wang L, Yang S, Wu Y, Chen H, Wu Y, Wang Q. Sintilimab plus anlotinib as second or further-line therapy for extensive disease small cell lung cancer: a phase 2 investigator-initiated non-randomized controlled trial. EClinicalMedicine. 2024 Mar 14;70:102543. doi: 10.1016/j.eclinm.2024.102543. eCollection 2024 Apr.'}]}, 'descriptionModule': {'briefSummary': 'This is a single arm, multi-center clinical trial. The goal of this clinical trial is to evaluate the efficacy, safety and biomarkers of Tafolecimab combined with Sintilimab and Chemotherapy as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). Tafolecimab is a recombinant fully humanized monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK-9), which can reduce low-density lipoprotein-C levels and increase the expression level of major histocompatibility complex class I (MHC-I) on tumor cells. Sintilimab is a fully humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1).', 'detailedDescription': 'Eligible patients will receive 4 cycles of Tafolecimab (300mg, sc, d1, Q3W) in combination with Sintilimab (200mg, iv, d1, Q3W), along with etoposide and either carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2) administered intravenously on days 1, 2, and 3 of each 3-week cycle for up to 4 to 6 cycles. Subsequently, patients will receive maintenance therapy with Sintilimab and Tafolecimab until disease progression, the occurrence of intolerable toxicities, or the treatment duration reaches 2 years. If the investigator assesses potential evidence of clinical benefit, continuing treatment after disease progression is permitted.\n\nPRIMARY OBJECTIVES:\n\nI. To evaluate the progression-free survival (PFS) of Tafolecimab combined with Sintilimab and chemotherapy as first-line treatment regimens for patients with extensive-stage small cell lung cancer (ES-SCLC).\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the safety of of Tafolecimab combined with Sintilimab and chemotherapy as first-line treatment regimens for patients with ES-SCLC.\n\nII. To evaluate the PFS rate, objective response rate (ORR), disease control rate (DCR), duration of response (DOR), overall survival (OS) rate and OS of Tafolecimab combined with Sintilimab and chemotherapy as first-line treatment regimens for patients with ES-SCLC.\n\nTERTIARY OBJECTIVES:\n\nI. To evaluate whether Tafolecimab combined with Sintilimab and chemotherapy as first-line treatment for patients with ES-SCLC could upregulate the expression of MHC-I on SCLC tumor cells.\n\nII. To explore tissue and liquid biopsy biomarkers that may be predictive of response or primary resistance to Tafolecimab combined with Sintilimab and chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age ≥18 years, ECOG performance status 0-1;\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to Veterans Administration Lung Study Group criteria;\n* Previously not receiving systemic treatment for ES-SCLC;\n* Greater than or equal to 1 measurable lesion exists according to RECIST v1.1;\n* Expected survival \\>= 12 weeks;\n* Adequate organ system functions (no blood transfusion or component blood use within 14 days before testing).\n\nKey Exclusion Criteria:\n\n* Previously receiving systemic anti-tumor therapy for ES-SCLC;\n* Combined SCLC (mixed SCLC and NSCLC histological types) or transformed SCLC confirmed by histological or cytological examination;\n* Receiving other investigational drugs or participated in other interventional clinical studies within 4 weeks before signing the informed consent form;\n* Receiving systemic immunostimulant treatment within 4 weeks before enrollment;\n* Active central nervous system (CNS) metastases (asymptomatic patients with stable lesions allowed);\n* Severe cardiovascular disease;\n* Severe chronic/active infections requiring systemic antibacterial, antifungal or antiviral treatment within 2 weeks before enrollment;\n* Active hepatitis B virus (HBV)/ hepatitis C virus (HCV)/ human immunodeficiency virus (HIV) infection;\n* Active autoimmune diseases, a history of interstitial lung disease, or other uncontrolled systemic diseases;\n* Pregnancy or lactation;\n* Having a disease that requires systemic corticosteroids or other immunosuppressants to be treated within ≤14 days before enrollment;\n* Requiring at least monthly or more frequent drainage of pleural and/or pericardial or peritoneal effusion;\n* Using attenuated live vaccines, or planned to receive attenuated live vaccines within 28 days before enrollment;\n* Known to be allergic to Sintilimab or Tafolecimab or its excipients, having a history of severe allergic reaction to any monoclonal antibody, or having a history of allergy to cisplatin, carboplatin or etoposide;\n* Toxicity caused by previous anti-cancer treatment has not recovered to baseline or stable state at the time of enrollment;\n* Creatinine clearance rate \\< 60 mL/min (cisplatin) or \\< 45 mL/min (carboplatin)\n* Uncontrolled or symptomatic hypercalcemia.'}, 'identificationModule': {'nctId': 'NCT07061535', 'acronym': 'STAR-SCLC', 'briefTitle': 'Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Efficacy and Safety of Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (STAR-SCLC)：A Prospective, Single Arm Trial', 'orgStudyIdInfo': {'id': '2025LSYD0847H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tafolecimab + Sintilimab + Chemotherapy', 'description': 'Eligible patients will receive 4 cycles of Tafolecimab (300 mg, sc, d1, Q3W) in combination with Sintilimab (200 mg, iv, d1, Q3W), along with etoposide and either carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2) for up to 4 to 6 cycles. Subsequently, they will receive maintenance therapy with Sintilimab and Tafolecimab until disease progression, the occurrence of intolerable toxicities, or the completion of 2 years of treatment. Etoposide (100 mg/m2) will be administered intravenously on days 1, 2, and 3 of each 3-week cycle, while carboplatin or cisplatin will be given intravenously on day 1 of each 3-week cycle.', 'interventionNames': ['Drug: Tafolecimab', 'Drug: Sintilimab (approved)', 'Drug: Etoposide', 'Drug: Carboplatin / Cisplatin']}], 'interventions': [{'name': 'Tafolecimab', 'type': 'DRUG', 'description': 'Patients will receive Tafolecimab 300 mg every 3 weeks.', 'armGroupLabels': ['Tafolecimab + Sintilimab + Chemotherapy']}, {'name': 'Sintilimab (approved)', 'type': 'DRUG', 'description': 'Patients will receive Sintilimab 200 mg every 3 weeks.', 'armGroupLabels': ['Tafolecimab + Sintilimab + Chemotherapy']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Patients will recieve Etoposide (100 mg/m2) intravenously on days 1, 2, and 3 of each 3-week cycle.', 'armGroupLabels': ['Tafolecimab + Sintilimab + Chemotherapy']}, {'name': 'Carboplatin / Cisplatin', 'type': 'DRUG', 'description': 'Patients will receive carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2) intravenously on day 1 of each 3-week cycle for up to 4 to 6 cycles.', 'armGroupLabels': ['Tafolecimab + Sintilimab + Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'contacts': [{'name': 'Yongchang Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'zhangyongchang@csu.edu.cn', 'phone': '+8613873123436'}], 'facility': 'Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Xiangjiao Meng, MD, PhD', 'role': 'CONTACT', 'email': 'mengxiangjiao@sina.com', 'phone': '+8613793150996'}], 'facility': 'Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Jing Qin, MD, PhD', 'role': 'CONTACT', 'email': 'qinjing@zjcc.org.cn'}], 'facility': 'Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Jian Ruan, MD, PhD', 'role': 'CONTACT', 'email': 'software233@zju.edu.cn'}], 'facility': 'First Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Yang Xia, MD, PhD', 'role': 'CONTACT', 'email': 'yxia@zju.edu.cn', 'phone': '+8618868439669'}], 'facility': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yang Xia, MD, PhD', 'role': 'CONTACT', 'email': 'yxia@zju.edu.cn', 'phone': '+8618868439669'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovent Biologics, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}