AL8326 in advanced Small Cell Lung Cancer

Phase 3

• Conditions: Small Cell Lung Cancer; Cancer

• Registration Number: ISRCTN79004846
• Lead Sponsor: Advenchen Pharmaceuticals, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-02
• Last Update Posted: 13 May 2024
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

1. All subjects or legal representatives must sign by the Ethics Committee approved informed consent prior to the start of any screening procedures;
2. Age = 18 years, male or female;
3. Histologically or cytologically confirmed small cell lung cancer patients who have recurrent or advanced disease after at least two lines of systemic regimen (including first-line platinum-based therapy, second-line monotherapy or other therapies *);
4. At least one measurable tumor lesion according to RECIST 1.1 *;
5. Previously received cytotoxic chemotherapy and/or immunotherapy, and the end of the last dose is at least 4 weeks apart from the first dose of study drug; the end of antitumor herb medicine is at least 14 days apart; the end of nitroso or mitomycin was at least 6 weeks apart, and tyrosine kinase inhibitors (TKIs) class molecular targeted drugs were at least 4 weeks apart; the treatment of brain metastases/bone metastases had to be at least 2 weeks apart; and had recovered to = Grade 1 from the toxicity of previous treatment [except for the following: a. alopecia; b. long-term toxicity caused by radiotherapy, which could not be recovered in the judgment of the investigator; c. platinum-induced Grade 2 and the following neurotoxicity such as hearing impairment (according to the Common Terminology Criteria for Adverse Events CTCAE V5.0)];
6. Expected survival time of at least 12 weeks;
7. ECOG (PS) score of 0 to 2;
8. Subject has adequate organ and bone marrow function and meets the following laboratory criteria: a. Blood routine test, b. Liver function, c. Renal function, d. Coagulation function, e. Left ventricular ejection fraction (LVEF) > 50% at screening
9. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use a medically licensed contraceptive method (condom, contraceptive sponge, contraceptive gel, contraceptive membrane, intrauterine device, oral or injectable contraceptives, subcutaneous implants, etc.) during treatment and within 3 months after the end of treatment;
10. Capable and willing to comply with protocol requirements during the study and subsequent procedures.

Exclusion Criteria

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 scr

Study & Design

• Study Type: Interventional
• Study Design: Not specified