Actively Recruiting
Phase III Clinical Study of AL8326 Tablets in Patients With Advanced or Recurrent Small Cell Lung Cancer After at Least Prior Second-line Treatment
Led by Advenchen Laboratories Nanjing Ltd. · Updated on 2024-02-08
243
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of AL8326 tablets in patients with small cell lung cancer (SCLC) who have experienced disease progression or recurrence after receiving at least two prior treatment regimens. This phase III, multicenter, randomized, double-blind, placebo-controlled study aims to compare AL8326 tablets with a placebo in this patient population. The study involves patients with confirmed SCLC who need third-line or later therapy and have measurable tumor lesions. Participants are randomly assigned in a 2:1 ratio to receive either AL8326 tablets or a placebo. Both treatments are given orally once daily in 28-day cycles, continuing until intolerable side effects, disease progression, death, voluntary withdrawal, or up to 12 months (about 13 cycles). After treatment ends, participants have a final visit and then enter a long-term follow-up period where tumor status is monitored based on RECIST 1.1 criteria. Throughout the study, participants undergo regular assessments including overall survival tracked up to three years, progression-free survival, tumor response rates, duration of remission, disease control, and monitoring for adverse events. Blood samples are collected at specified cycles to measure plasma drug concentration. The study also includes safety monitoring and requires participants to meet specific health criteria before and during treatment.
CONDITIONS
Brief 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 prior to screening
- Age 18 years or older, any gender
- Confirmed small cell lung cancer with recurrence or advanced disease after at least two prior systemic treatment lines
- At least one measurable tumor lesion per RECIST 1.1
- Expected survival time of at least 12 weeks
- ECOG performance status score between 0 and 2
- Adequate organ and bone marrow function based on specific laboratory tests
- Female participants of childbearing potential must have a negative pregnancy test and agree to use contraception during and 3 months after treatment; male participants must agree to use contraception during and 3 months after treatment
- Willing and able to comply with study protocol and procedures
You will not qualify if you...
- Known uncontrolled allergy to AL8326 or similar compounds
- Prior use of AL8326 tablets
- History or presence of leptomeningeal disease or symptomatic CNS metastases within 8 weeks before dosing, unless stable
- Other cancers unless fully treated and no recurrence for 2 years
- Significant gastrointestinal issues affecting drug intake or absorption
- Uncontrolled primary diseases such as severe hypertension, arrhythmia, heart failure, active autoimmune or lung diseases, or thyroid conditions affecting study evaluation
- Recent cytotoxic chemotherapy, immunotherapy, or certain other treatments within specified timeframes
- Recent arterial or severe venous thrombosis within 6 months
- Tumor invasion of important vessels risking fatal hemorrhage
- Uncontrolled infection within 14 days before first dose
- Significant proteinuria or active bleeding risk
- Use of certain anticoagulants during screening, with some low-dose exceptions
- Positive tests for hepatitis C, HIV, or active hepatitis B
- Participation in other clinical trials within 4 weeks before consent
- Recent major surgery or unhealed wounds
- History of organ transplantation or planned transplantation
- Other reasons deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months (approximately 13 cycles)
Participants take oral AL8326 tablets or placebo once daily in 28-day cycles until disease progression, intolerable toxicity, death, voluntary withdrawal, or up to 12 months (approximately 13 cycles).
Monthly visits for treatment assessments during each 28-day cycle
Duration - Up to 3 years after treatment start
Participants have a final visit followed by a long-term follow-up period to monitor overall survival and tumor status.
Periodic visits for long-term survival monitoring
Trial Site Locations
Total: 1 location
1
JILIN Cancer Hospital
Changchun, Jilin, China, 130000
Actively Recruiting
Research Team
Y
yingyin Li
H
Huaqing He
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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