First-line immunotherapy plus chemotherapy in extensive-stage small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, multi-center Phase 2 trial evaluating the combination of Tafolecimab, Sintilimab, and chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). Participants receive four cycles of Tafolecimab and Sintilimab with etoposide and either carboplatin or cisplatin, followed by maintenance therapy until progression or intolerable toxicity. The study aims to measure progression-free survival and safety, with secondary analyses of response rates and overall survival, and explores potential biomarkers such as MHC-I expression. Eligible patients are adults with untreated ES-SCLC, adequate organ function, and measurable disease; key exclusions include prior systemic therapy for ES-SCLC and active CNS disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science
  Jinan, Shandong, China Recruiting
• Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
  Hangzhou, Zhejiang, China Recruiting
• First Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting
• Second Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting
• Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
  Changsha, Hunan, China Not yet recruiting

Study contacts

• Study coordinator: Yang Xia, MD, PhD
• Email: yxia@zju.edu.cn
• Phone: +8618868439669

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.