Actively Recruiting
A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2025-02-11
438
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was designed to compare the efficacy and safety of YL201 with Topotecan Hydrochloride in subjects with relapsed small cell lung cancer (SCLC).
CONDITIONS
Official Title
A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Age between 18 and 75 years, male or female
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed small cell lung cancer (SCLC), excluding combined or transformed SCLC
- Limited or extensive-stage disease with progression after at least 2 cycles of first-line platinum-based therapy
- At least one measurable tumor lesion according to RECIST version 1.1
- Willingness to provide tumor tissue for B7-H3 expression testing
- Adequate organ function
You will not qualify if you...
- History of other cancers within 5 years, except certain treated skin or in situ cancers
- Prior treatment with B7-H3-targeted therapies or topoisomerase I inhibitors
- Insufficient washout period from previous anti-tumor treatments
- Recent use of systemic steroids or immunosuppressive therapy within 2 weeks
- Recent live vaccine within 4 weeks or planned during the study
- Brain stem, meningeal, or spinal cord metastases or compression
- Untreated or symptomatic central nervous system metastases; treated brain metastases must be stable and asymptomatic
- Symptomatic pleural, pericardial effusions, or ascites requiring repeated drainage
- Uncontrolled concurrent diseases or severe cardiovascular disorders
- History or current interstitial lung disease or pneumonitis requiring corticosteroids
- Severe pulmonary disorders causing respiratory impairment
- Chronic autoimmune or inflammatory diseases needing systemic therapy within 2 years
- Serious infections within 4 weeks prior to study drug
- Active hepatitis B or C infection
- Unresolved toxicities from previous cancer treatments
- Known severe allergy or hypersensitivity to study drugs or similar biologics
- Pregnancy, breastfeeding, or planning pregnancy or breastfeeding during the study
- Any condition or situation interfering with informed consent or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
X
Xianfeng Zhu
CONTACT
X
Xian Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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