Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

NCT07061535 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2025LSYD0847H
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

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).

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

Keywords

Tafolecimab; Sintilimab; immunotherapy; PCSK9 inhibitor; SCLC

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival as Assessed by RECIST v1.1

  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.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (7)

• Objective Response Rate as Assessed by RECIST v1.1

  From enrollment to the end of treatment at 12 months

• Progression-free Survival Rate as Assessed by RECISIT v1.1

  From enrollment to the end of treatment at 6 months and 12 months

• Overall Survival Rate as Assessed by RECISIT v1.1

  From enrollment to the end of treatment at 12 months and 24 months

• Disease Control Rate as Assessed by RECISIT v1.1

  From enrollment to the end of treatment at 12 months

• Duration of Response as Assessed by RECISIT v1.1

  From enrollment to the end of treatment at 12 months

Study Arms (1)

Tafolecimab + Sintilimab + Chemotherapy

EXPERIMENTAL

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.

Drug: Tafolecimab; Drug: Sintilimab (approved); Drug: Etoposide; Drug: Carboplatin / Cisplatin

Interventions

Tafolecimab DRUG

Patients will receive Tafolecimab 300 mg every 3 weeks.

Tafolecimab + Sintilimab + Chemotherapy

Sintilimab (approved) DRUG

Patients will receive Sintilimab 200 mg every 3 weeks.

Tafolecimab + Sintilimab + Chemotherapy

Etoposide DRUG

Patients will recieve Etoposide (100 mg/m2) intravenously on days 1, 2, and 3 of each 3-week cycle.

Tafolecimab + Sintilimab + Chemotherapy

Carboplatin / Cisplatin DRUG

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.

Tafolecimab + Sintilimab + Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, ECOG performance status 0-1;
• Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to Veterans Administration Lung Study Group criteria;
• Previously not receiving systemic treatment for ES-SCLC;
• Greater than or equal to 1 measurable lesion exists according to RECIST v1.1;
• Expected survival \>= 12 weeks;
• Adequate organ system functions (no blood transfusion or component blood use within 14 days before testing).

You may not qualify if:

• Previously receiving systemic anti-tumor therapy for ES-SCLC;
• Combined SCLC (mixed SCLC and NSCLC histological types) or transformed SCLC confirmed by histological or cytological examination;
• Receiving other investigational drugs or participated in other interventional clinical studies within 4 weeks before signing the informed consent form;
• Receiving systemic immunostimulant treatment within 4 weeks before enrollment;
• Active central nervous system (CNS) metastases (asymptomatic patients with stable lesions allowed);
• Severe cardiovascular disease;
• Severe chronic/active infections requiring systemic antibacterial, antifungal or antiviral treatment within 2 weeks before enrollment;
• Active hepatitis B virus (HBV)/ hepatitis C virus (HCV)/ human immunodeficiency virus (HIV) infection;
• Active autoimmune diseases, a history of interstitial lung disease, or other uncontrolled systemic diseases;
• Pregnancy or lactation;
• Having a disease that requires systemic corticosteroids or other immunosuppressants to be treated within ≤14 days before enrollment;
• Requiring at least monthly or more frequent drainage of pleural and/or pericardial or peritoneal effusion;
• Using attenuated live vaccines, or planned to receive attenuated live vaccines within 28 days before enrollment;
• 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;
• Toxicity caused by previous anti-cancer treatment has not recovered to baseline or stable state at the time of enrollment;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Innovent Biologics, Inc.: collaborator

Study Sites (5)

Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

Changsha, Hunan, China

Location

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science

Jinan, Shandong, China

Location

Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences

Hangzhou, Zhejiang, China

Location

First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

Related Publications (4)

• 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: 38630789 BACKGROUND

• 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: 39657676 BACKGROUND

• 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: 33177715 BACKGROUND

• 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.

  PMID: 38516099 BACKGROUND

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

sintilimab; Etoposide; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Yang Xia, MD, PhD

CONTACT

+8618868439669; yxia@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Tafolecimab combined with Sintilimab and Chemotherapy as the first-line treatment regimen

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-06

Locations

CN (5)