Actively Recruiting
Study of Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Limited-stage Small Cell Lung Cancer (LS-SCLC)
Led by Guangdong Provincial People's Hospital · Updated on 2025-04-04
45
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
G
Guangdong Provincial People's Hospital
Lead Sponsor
L
Liaoning Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We aimed to evaluate the efficacy and safety of surgical resection or chemotherapy following serplulimab plus platinum-containing dual induction therapy for stage II-IIIB (N2) LS-SCLC
CONDITIONS
Official Title
Study of Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Limited-stage Small Cell Lung Cancer (LS-SCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 to 75 years
- Confirmed diagnosis of small cell lung cancer
- Clinically staged as IIB-IIIB (N2)
- No previous systemic anti-tumor treatment or chest radiotherapy
- No contraindications to surgery as evaluated by surgeons
- At least one measurable tumor lesion on imaging
- ECOG performance status score of 0 or 1
- Expected survival time greater than 6 months
- Negative hepatitis B surface antigen and core antibody, or controlled hepatitis B infection
- Sufficient organ and bone marrow function without serious abnormalities
- Female participants must be menopausal, surgically sterilized, or have a negative pregnancy test and use effective contraception
- Male participants must agree to abstain from sex or use contraception if partner is of childbearing potential
- Previous non-systemic anti-tumor treatments ended at least 2 weeks before enrollment with adverse events recovered to grade 1 or less except alopecia
You will not qualify if you...
- Mixed small cell lung cancer confirmed by tests
- Previous systemic treatment for small cell lung cancer
- Other active cancers within 5 years except certain localized cured tumors
- History of organ or bone marrow transplant
- Pleural, pericardial effusion, or ascites requiring intervention
- Recent heart attack or uncontrolled heart rhythm problems
- Uncontrolled high calcium levels in the blood
- Peripheral neuropathy of grade 2 or higher
- HIV infection
- Active tuberculosis
- Lung diseases that may interfere with therapy or detection
- Active hepatitis B or C infection not controlled
- Active or suspected autoimmune diseases needing systemic treatment
- Live vaccine use within 28 days prior to study
- Use of systemic corticosteroids or immunosuppressants above allowed doses
- Active infection requiring systemic treatment or current COVID-19 infection
- Major surgery within 28 days before starting study drug
- Prior treatment with immune checkpoint inhibitors
- Participation in other interventional studies less than 28 days before
- History of severe allergies to monoclonal antibodies
- Known allergy to study drug components
- Pregnant or breastfeeding women
- History of psychotropic drug abuse
- Other conditions judged by researchers to affect study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
C
Chen Huang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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