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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Olga
Peycheva
+44 74 84105719
Olga.peycheva@solutionsop.co.uk
Dr
Anja
Williams
+44 2032195200
anja.williams@hcahealthcare.co.uk
Small Cell Lung Cancer
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
This is a multi-center, randomized, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy and safety of AL8326 tablets in patients with advanced or recurrent small cell lung cancer (SCLC) after at least prior second-line treatment.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Known uncontrollable hypersensitivity to AL8326 similar compounds; 2. Having previously used AL8326 tablets; 3. Having or had a history of leptomeningeal disease or leptomeningeal metastases at screening, or confirmed CNS metastases presenting with symptoms of uncontrolled brain metastases, spinal cord compression, or cancerous meningitis within 8 weeks of first dose, except for CNS metastases or spinal cord compression that are clinically stable and do not require corticosteroids and have an interval of greater than 2 weeks between screening and previous treatment (including radiation therapy or surgery);4. Having or had other neoplasms unless radically treated and with no evidence of recurrence or metastasis within the past 2 years; 5. Having significant gastrointestinal history or current illness, such as inability to swallow, severe peptic ulcer, uncontrollable nausea and vomiting, and clinical difficulty in controlling chronic diarrhea, intestinal obstruction or other chronic gastrointestinal diseases in the past 3 months, which may affect the intake, transport or absorption of drugs as judged by the investigator, or who have previously undergone total gastrectomy; 6. Having other important primary diseases, such as single agent uncontrolled hypertension , arrhythmia requiring clinical intervention, abnormally prolonged arrhythmia caused by unstable coronary artery disease, decompensated congestive heart failure or myocardial infarction, unstable angina pectoris, ascites or pleural effusion with uncontrolled within 6 months before the administration of the IMP (CTCAE 5.0 ≥ 2), active autoimmune diseases, mental illness, symptomatic or interstitial lung disease requiring treatment, thyroid disease that may seriously affect the trial evaluation;7. Had arterial thrombosis or severe venous thromboembolic events within 6 months before screening, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism; 8. Having imaging findings indicating that the tumor has invaded around important vessels at screening or the tumor is likely to invade important vessels and cause fatal massive hemorrhage during the subsequent study period as judged by the investigator; 9. Uncontrolled infection within 14 days prior to first dose; 10. Screening urine routine showed urine protein ≥ + +, and 24-hour urine protein > 1.0 g; 11. Having active bleeding within 3 months before screening or at high risk of bleeding as judged by the investigator; 12. Been receiving anticoagulants or vitamin K antagonists (e.g., warfarin, heparin, or their analogues) during the screening period [low-dose anticoagulants such as warfarin (no more than 1 mg daily orally), low-dose heparin (no more than 12,000 U daily), or low-dose aspirin (no more than 100 mg daily) were permitted for prophylactic purposes provided INR was ≤ 1.5]; 13. Having positive test results for hepatitis C virus (HCV) antibody, treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody, or active hepatitis B (defined as hepatitis B virus HBV DNA ≥ 2000 IU/mL or HBV DNA ≥ 10 ^ 4 copies); 14. Participated in other clinical trials (excluding observational or vitamin studies) within 4 weeks before informed consent; 15. Having received major surgical treatment within 6 weeks prior to screening (patients must be fully recovered and stable before the start of treatment) or serious unhealed wounds, ulcers or fractures at screening; 16. Having a history of organ transplantation or being prepared to undergo organ transplantation; 17. Other reasons that, in the discretion of the investigator, would make participation in this study inappropriate.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Anja
Williams
+44 2032195200
anja.williams@hcahealthcare.co.uk
Dr
Olga
Peycheva
+44 74 84105719
Olga.peycheva@solutionsop.co.uk
The study is sponsored by Advenchen Pharmaceuticals, LLC and funded by Advenchen Pharmaceuticals, LLC.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 55935
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
