Actively Recruiting
SKB500 Combinations in Patients With Small Cell Lung Cancer
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
80
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.
CONDITIONS
Official Title
SKB500 Combinations in Patients With Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants between 18 and 75 years old
- Histologically or cytologically confirmed extensive-stage small cell lung cancer
- Cohort 1: participants with up to 1 prior systemic therapy for extensive-stage disease
- Cohort 2 and 3: participants with no prior systemic treatment
- Agreement to provide fresh or archival tumor tissue for biomarker analysis
- At least one measurable lesion per RECIST Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ and bone marrow functions
- Recovery to grade 1 or less from prior anti-cancer treatment toxicities
- Use of effective contraception during the study and for 6 months after treatment
- Voluntary participation with signed informed consent and ability to comply with study visits and procedures
You will not qualify if you...
- Mixed pathology with both non-small cell and small cell carcinoma components
- Previous treatment with medications targeting the same pathways or toxins
- Spinal cord compression or active central nervous system metastases
- Clinical symptoms from tumor invasion or compression of vital organs or blood vessels
- Severe infection within 4 weeks or active infection requiring systemic treatment within 2 weeks before first dose
- Peripheral neuropathy of grade 2 or higher
- History of serious or life-threatening adverse events from immunotherapy
- Uncontrolled concurrent diseases such as liver cirrhosis, nephrotic syndrome, metabolic disorders, severe peptic ulcer, gastrointestinal bleeding or obstruction
- Serious or uncontrolled heart disease requiring treatment
- History or current interstitial lung disease or noninfectious pneumonitis requiring steroids
- Severe lung damage from other lung diseases
- Uncontrolled hypertension, diabetes, or repeated drainage of pleural, pericardial, or abdominal effusions
- Pregnant or breastfeeding women
- Rapid disease worsening during screening process
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Y
Yan Qing
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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