Actively Recruiting
A Phase IIII Study of AL8326 in Small Cell Lung Cancer
Led by Advenchen Laboratories Nanjing Ltd. · Updated on 2024-02-08
243
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of AL8326 tablets in small cell lung cancer (SCLC) patients with disease progression or recurrence after receiving at least second-line treatment regimens.
CONDITIONS
Official Title
A Phase IIII Study of AL8326 in Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any screening procedures
- Age 18 years or older, male or female
- Histologically or cytologically confirmed small cell lung cancer
- Disease recurrence or progression after at least two prior systemic treatments
- At least one measurable tumor lesion per RECIST 1.1 criteria
- Expected survival of at least 12 weeks
- ECOG performance status score between 0 and 2
- Adequate organ and bone marrow function meeting specified blood, liver, kidney, coagulation, and heart function levels
- For females of childbearing potential, negative pregnancy test within 7 days prior to enrollment and agreement to use approved contraception during and 3 months after treatment
- Male subjects surgically sterilized or agreeing to use contraception during and 3 months after treatment
- Willingness and ability to comply with study protocol
You will not qualify if you...
- Known uncontrolled allergy to AL8326 or related compounds
- Previous use of AL8326 tablets
- History of leptomeningeal disease or symptomatic CNS metastases within 8 weeks prior to first dose
- Other cancers unless successfully treated with no recurrence in past 2 years
- Significant gastrointestinal conditions affecting drug intake or absorption
- Uncontrolled primary diseases such as hypertension, arrhythmia, heart failure, or autoimmune diseases
- Recent cytotoxic chemotherapy, immunotherapy, or other treatments within specified time frames
- Arterial or venous thrombosis in past 6 months
- Tumor invasion near major blood vessels with risk of fatal bleeding
- Uncontrolled infection within 14 days prior to first dose
- Significant proteinuria or active bleeding
- Use of anticoagulants except low-dose allowed for prophylaxis
- Positive tests for hepatitis C, HIV, active hepatitis B
- Participation in other clinical trials within 4 weeks prior to consent
- Major surgery within 6 weeks prior to screening or unhealed wounds
- History or plan for organ transplantation
- Other investigator-determined reasons making participation inappropriate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
JILIN Cancer Hospital
Changchun, Jilin, China, 130000
Actively Recruiting
Research Team
Y
yingyin Li
CONTACT
H
Huaqing He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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