Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT07061535
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07061535
Study Brief:
Protocol Section:
NCT07061535