Clinical trial · Interventional
Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive Disease Small Cell Lung Cancer | — | UNRESOLVED | — |
| Extensive Stage Lung Small Cell Cancer | — | UNRESOLVED | — |
| Extensive-Stage Small-Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Extensive-stage Small Cell Lung Cancer (ES-SCLC) | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin / Cisplatin | Drug | — | UNRESOLVED |
| Etoposide | Drug | Etoposide | ALIAS |
| Sintilimab (approved) | Drug | Sintilimab | ALIAS |
| Tafolecimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * 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). Key Exclusion Criteria: * 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; * Creatinine clearance rate \< 60 mL/min (cisplatin) or \< 45 mL/min (carboplatin) * Uncontrolled or symptomatic hypercalcemia.
References
Publications (4)
- BACKGROUNDZugazagoitia 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
- BACKGROUNDMei 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
- BACKGROUNDLiu 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
- BACKGROUNDMa 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