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Extensive-stage Small Cell Lung Cancer (ES-SCLC)Phase 2STAR-SCLCNCT07061535

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

A Phase 2 study testing Tafolecimab, Sintilimab (approved) and Etoposide in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC) and Extensive Stage Lung Small Cell Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tafolecimab, Sintilimab (approved) and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesChina
Study dates
30 Jul 2025to 1 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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;
Show all 17Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yang Xia, MD, PhD contact

+8618868439669

yxia@zju.edu.cn

5 sites in 1 country

China5 sites, 5 recruiting

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

    Changsha, Hunan

    Yongchang Zhang, MD, PhD, +8613873123436, zhangyongchang@csu.edu.cn

    Not yet recruiting

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

    Hangzhou, Zhejiang

    Jing Qin, MD, PhD, qinjing@zjcc.org.cn

    Recruiting

  • First Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang

    Jian Ruan, MD, PhD, software233@zju.edu.cn

    Recruiting

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang

    Yang Xia, MD, PhD, +8618868439669, yxia@zju.edu.cn

    Recruiting

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

    Jinan, Shandong

    Xiangjiao Meng, MD, PhD, +8613793150996, mengxiangjiao@sina.com

    Recruiting

Other trials in China

About this study

Official title: 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

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).

Read the detailed description

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:

  1. 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:

  1. 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:

  1. 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.

Being tested
Tafolecimab, Sintilimab (approved), Etoposide, Carboplatin / Cisplatin
Keywords
Tafolecimab, Sintilimab, immunotherapy, PCSK9 inhibitor, SCLC
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TafolecimabDrug

    Patients will receive Tafolecimab 300 mg every 3 weeks.

  • Sintilimab (approved)Drug

    Patients will receive Sintilimab 200 mg every 3 weeks.

  • EtoposideDrug

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

  • Carboplatin / CisplatinDrug

    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.

Study groups in NCT07061535
Study groupRoleWhat they receive
Tafolecimab + Sintilimab + ChemotherapyExperimentalEligible 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.
Receives: Drug: Tafolecimab; Drug: Sintilimab (approved); Drug: Etoposide; Drug: Carboplatin / Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of treatment at 12 months

Secondary outcomes (7)

  1. 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.

    Measured: From enrollment to the end of treatment at 12 months

  2. 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.

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

  3. 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.

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

  4. 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).

    Measured: From enrollment to the end of treatment at 12 months

  5. 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).

    Measured: From enrollment to the end of treatment at 12 months

  6. Percentage of Participants with Treatment-Related Adverse Events as Assessed by NCI-CTCAE v5.0

    Measured: From enrollment to the end of treatment at 12 months

  7. 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).

    Measured: From enrollment to the end of treatment at 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start30 Jul 2025
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Tafolecimab combined with Sintilimab and Chemotherapy as the first-line treatment regimen
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07061535
Sponsor's protocol ID
2025LSYD0847H
Acronym
STAR-SCLC
Status last verified
Sep 2026
First submitted
2 Jul 2025
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38630789

  • 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.

    PubMed 39657676

  • 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.

    PubMed 33177715

  • 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.

    PubMed 38516099

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tafolecimab, Sintilimab (approved) and Etoposide in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC) and Extensive Stage Lung Small Cell Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yang Xia, MD, PhD (+8618868439669, yxia@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival as Assessed by RECIST v1.1 (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07061535, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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