A Phase 2 interventional study of Tafolecimab and Sintilimab (approved) in Extensive-stage Small Cell Lung Cancer (ES-SCLC), Extensive Stage Lung Small Cell Cancer and Extensive-Stage Small-Cell Lung Cancer, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 2, Interventional, and Treatment
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).
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.
PRIMARY OBJECTIVES:
I. 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).
SECONDARY OBJECTIVES:
I. To evaluate the safety of of Tafolecimab combined with Sintilimab and chemotherapy as first-line treatment regimens for patients with ES-SCLC.
II. 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.
TERTIARY OBJECTIVES:
I. 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.
II. To explore tissue and liquid biopsy biomarkers that may be predictive of response or primary resistance to Tafolecimab combined with Sintilimab and chemotherapy.
1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.
This study's planned enrollment of 40 is below the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 59 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
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
Patients will receive Tafolecimab 300 mg every 3 weeks.
Patients will receive Sintilimab 200 mg every 3 weeks.
Patients will recieve Etoposide (100 mg/m2) intravenously on days 1, 2, and 3 of each 3-week cycle.
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.
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.
Time frame: From enrollment to the end of treatment at 12 months
Objective Response Rate as Assessed by RECIST v1.1
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.
Time frame: From enrollment to the end of treatment at 12 months
Progression-free Survival Rate as Assessed by RECISIT v1.1
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.
Time frame: From enrollment to the end of treatment at 6 months and 12 months
Overall Survival Rate as Assessed by RECISIT v1.1
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.
Time frame: From enrollment to the end of treatment at 12 months and 24 months
Disease Control Rate as Assessed by RECISIT v1.1
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).
Time frame: From enrollment to the end of treatment at 12 months
Duration of Response as Assessed by RECISIT v1.1
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).
Time frame: From enrollment to the end of treatment at 12 months
Percentage of Participants with Treatment-Related Adverse Events as Assessed by NCI-CTCAE v5.0
Time frame: From enrollment to the end of treatment at 12 months
Overall survival as Assessed by RECISIT v1.1
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).
Time frame: From enrollment to the end of treatment at 24 months
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Second Affiliated Hospital, Zhejiang University, School of Medicine