Actively Recruiting
Serplulimab Combined With CCRT for LS-SCLC.
Led by Peking Union Medical College Hospital · Updated on 2024-07-22
96
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC). Studies have found that, compared to chemotherapy alone, the combination of Surlidumab with carboplatin and etoposide can extend the median overall survival in ES-SCLC to over 15 months. However, to date, research on the use of immunotherapy in combination with concurrent chemoradiotherapy (CCRT) in limited-stage small cell lung cancer (LS-SCLC) remains limited. This study aims to explore the clinical benefits of Surlidumab in combination with concurrent chemoradiotherapy in LS-SCLC and evaluate the safety of immunotherapy in combination with CCRT as first-line treatment for LS-SCLC. At the same time, it seeks to identify tumor-related biomarkers that can effectively predict the efficacy of immunotherapy and prognosis.
CONDITIONS
Official Title
Serplulimab Combined With CCRT for LS-SCLC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with limited-stage small cell lung cancer (stage II-III)
- No prior targeted therapy, chemotherapy, radiation, or immunotherapy for lung cancer
- Measurable tumors based on RECIST 1.1 criteria
- ECOG performance status of 0 to 1
- Adequate bone marrow, blood chemistry, and urine function
- Life expectancy of at least 6 months
- Male participants agree to use effective contraception during treatment and for 180 days after last dose and not donate sperm during this period
- Female participants are not pregnant or lactating and either not capable of reproduction or agree to use effective contraception during treatment and for 180 days after last dose
- Female participants capable of reproduction must have a negative pregnancy test within 72 hours before starting medication
- Signed informed consent form
You will not qualify if you...
- Extensive-stage small cell lung cancer
- Prior surgery, radiotherapy, chemotherapy, or immunotherapy for small cell lung cancer
- Stage I LS-SCLC suitable for surgery
- Active autoimmune disease needing systemic treatment within past 2 years
- History or current active pneumonia or interstitial lung disease requiring steroids
- Diagnosed immunodeficiency diseases
- Known HIV infection
- Active hepatitis B or C infection
- Known active tuberculosis
- Use of live or attenuated vaccines within 30 days before study treatment
- Other progressing cancers within past year needing treatment (except certain skin or in situ cancers)
- Symptomatic brain metastases or carcinomatous meningitis
- Severe allergy to nivolumab, platinum, etoposide, or their components
- Active infections needing systemic therapy
- Medical conditions posing excessive risk or interfering with study participation
- Psychiatric illness or substance abuse affecting compliance
- Pregnancy, lactation, planned pregnancy, or intent to conceive during study
- Prior allogeneic tissue or organ transplant
- Inability to comply with study visits
- Current or recent participation in other investigational drug or device studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
M
mengzhao Wang, MD
CONTACT
Y
Yan Xu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here