Status:
NOT_YET_RECRUITING
Efficacy and Safety of Serplulimab With Chemotherapy and Aspirin in Untreated Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Conditions:
Extensive-Stage Small Cell Lung Cancer
Treatment-naïve for Systemic Therapy Targeting Extensive-Stage Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Lung cancer remains a leading cause of cancer-related deaths worldwide, with small cell lung cancer (SCLC) accounting for 15-20% of all lung cancers. Extensive-stage SCLC (ES-SCLC) is associated with ...
Detailed Description
In 2020, global cancer burden data showed 2.2 million new cases of lung cancer, ranking second, with 1.8 million deaths, far surpassing other cancer types and ranking first in cancer-related mortality...
Eligibility Criteria
Inclusion
- Males or females aged ≥ 18 years.
- Histologically or cytologically confirmed ES-SCLC (according to the Veterans Administration Lung Cancer Group \[VALG\] staging system).
- Treatment-naïve for systemic therapy targeting ES-SCLC.
- Patients must have at least one tumor lesion that meets the following criteria: previously untreated, accurately measurable, with a longest diameter ≥ 10 mm at baseline (for lymph nodes, short axis ≥ 15 mm), measurable by chest CT or PET-CT, as long as accurate repeat measurements can be performed.
- ECOG performance status score of 0 or 1.
- Expected survival ≥ 3 months.
- Planned treatment with Serplulimab combined with platinum-based chemotherapy.
- Patients who have previously taken or are currently taking Bayer Aspirin are allowed.
Exclusion
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- Currently receiving other anticoagulant therapy.
- Previous systemic anti-tumor therapy.
- Contraindications to the use of Serplulimab, Aspirin, or chemotherapy.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06554535
Start Date
October 1 2024
End Date
October 1 2027
Last Update
August 15 2024
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