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 @ 4:48 PM
Ignite Modification Date:
2025-12-24 @ 4:48 PM
NCT ID:
NCT05844150
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent form before any trial-related processes;
2. Age ≥18 years;
3. Histologically or cytologically confirmed ES-SCLC;
4. No prior systemic therapy for ES-SCLC;
5. Have adequate organ function;
6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
7. Life expectancy of ≥12 weeks;
8. Had at least one measurable tumor lesion according to RECIST v1.1.
Exclusion Criteria:
1. Histologically or cytologically confirmed mixed SCLC;
2. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
3. The toxicity of previous anti-tumor therapy has not been alleviated；
4. Have received anti-platelet therapy within 10 days prior to the first dose of the study drugs;
5. Evidence and history of severe bleeding tendency;
6. History of severe cardiovascular diseases within 6 months;
7. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
8. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
9. History of alcohol abuse, psychotropic substance abuse or drug abuse;
10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
11. Pregnant or lactating women;
12. Other conditions considered unsuitable for this study by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05844150
Study Brief:
Protocol Section:
NCT05844150