A Phase IIII Study of AL8326 in Small Cell Lung Cancer

NCT06247605 | Recruiting Phase 3 DMC

• 1 other identifier: AL8326-GB-010
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

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

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  The time between the date of randomization and the death of the subject from any cause.

  Cycle 1 Day 1 up to 3 years (each cycle is 28 days)

Secondary Outcomes (6)

• Progression-free survival (PFS)

  Cycle 1 Day 1 up to 12 months(each cycle is 28 days)

• Objective remission rate (ORR)

  12 months

• Duration of remission (DOR)

  12 months

• Disease Control Rate (DCR)

  12 months

• Adverse Events (AEs)

  Cycle 1 Day 1 up to 12 months(each cycle is 28 days)

Study Arms (2)

active group（AL8326）

EXPERIMENTAL

Oral AL8326 (28-day cycle, once daily) until confirmation of disease progression, intolerable toxicity or death, voluntary withdrawal from the study, for a total of no more than 12 months (approximately 13 cycles).

Drug: AL8326 tablets

Control group（Placebo)

PLACEBO COMPARATOR

Oral placebo (28-day cycle, once daily) until confirmation of disease progression, intolerable toxicity or death, voluntary withdrawal from the study, for a total of no more than 12 months (approximately 13 cycles).

Drug: placebo

Interventions

AL8326 tablets DRUG

10mg/tablet, Oral administration, once daily.

Also known as: AL8326

active group（AL8326）

placebo DRUG

Oral administration, once daily.

Control group（Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects or legal representatives must sign the informed consent form approved by the Ethics Committee in writing prior to the start of any screening procedures;
• Age ≥ 18 years, male or female;
• 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 \*);
• At least one measurable tumor lesion according to RECIST 1.1 \*\*;
• Expected survival time of at least 12 weeks;
• ECOG (PS) score of 0 to 2;
• Subject has adequate organ and bone marrow function and meets the following laboratory criteria:
• Blood routine test (without red blood cell or platelet transfusion or hematopoietic factor drug correction within 14 days before screening): absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L (1500/mm3), platelets ≥ 80 × 10\^9/L; hemoglobin ≥ 9.0 g/dL;
• Liver function: serum total bilirubin ≤ 1.5 × ULN (upper limit of normal), except for patients with Gilbert 's syndrome (persistent or recurrent hyperbilirubinemia, manifested as unconjugated bilirubin elevation in the absence of hemolysis or pathological evidence of liver); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN for patients without liver metastasis, and ALT and AST ≤ 5 × ULN for patients with liver metastasis;
• Renal function: Serum creatinine ≤ 1.5 × ULN and estimated standard cendogenous creatinine clearance rate ≥ 60 ml/min by Cockcroft-Gault formula, Ccr (ml/min) = \[(140-age) × body weight (kg)\]/\[72 × Scr (mg/dl)\], calculated for females × 0.85;
• Coagulation function: international normalized ratio (INR) ≤ 1.5;
• Left ventricular ejection fraction (LVEF) \> 50% at screening. 8.1) Female: For female subjects of childbearing potential, they must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use a medically approved method of contraception (condom, sponge, gel, diaphragm, IUD, oral or injectable contraceptive, subcutaneous implant, etc.) during and for 3 months after treatment; they must be non-pregnant and lactating. Female subjects are considered fertile if they are menopausal but have not reached post-menopausal status (menopause of 12 consecutive months or more, with no cause other than menopause) and have not undergone sterilization (removal of ovaries and/or uterus). Their sexual partner agrees to use a medically licensed method of contraception during the subject's treatment and for 3 months after completion; 2) Males: surgical sterilization or agreement to use medically licensed contraception during and for 3 months after the end of treatment; their sexual partners agree to use medically licensed contraception during and for 3 months after the end of the subject's treatment;
• \. Capable and willing to comply with protocol requirements during the study and subsequent procedures.

You may not qualify if:

• Known uncontrollable hypersensitivity to AL8326 similar compounds;
• Having previously used AL8326 tablets;
• 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);
• Having or had other neoplasms unless radically treated and with no evidence of recurrence or metastasis within the past 2 years;
• 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;
• Having other important primary diseases, such as single agent uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 95 mmHg), arrhythmia requiring clinical intervention (such as long QT syndrome, QTcF \> 470 ms), abnormally prolonged arrhythmia caused by unstable coronary artery disease, decompensated congestive heart failure (New York Heart Association(NYHA) class III or IV) or myocardial infarction, unstable angina pectoris, ascites or pleural effusion with uncontrolled within 6 months before the administration of the investigational product (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;
• 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 anti- tumor 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 \[except for the following: a. alopecia; b. long-term toxicity caused by radiotherapy, which could not be recovered in the judgment of the investigator; c. platinum-induced Grade 2 and the following neurotoxicity such as hearing impairment (according to the Common Terminology Criteria for Adverse Events CTCAE V5.0)\];
• 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;
• 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;
• Uncontrolled infection within 14 days prior to first dose;
• Screening urine routine showed urine protein ≥ + +, and 24-hour urine protein \> 1.0 g;
• Having active bleeding within 3 months before screening or at high risk of bleeding as judged by the investigator;
• Been receiving anticoagulants or vitamin K antagonists (e.g., warfarin, heparin, or their analogues) during the screening period \[low-dose anticoagulants such as warfarin (no more than 1 mg daily orally), low-dose heparin (no more than 12,000 U daily), or low-dose aspirin (no more than 100 mg daily) were permitted for prophylactic purposes provided INR was ≤ 1.5\];
• 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);
• Participated in other clinical trials (excluding observational or vitamin studies) within 4 weeks before informed consent;

Sponsors & Collaborators

• Advenchen Laboratories Nanjing Ltd.: lead

Study Sites (1)

JILIN Cancer Hospital

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ying Cheng

  Jilin Provincial Tumor Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yingyin Li

CONTACT

+8657188683590; anne@advenchen.com.cn

Huaqing He

CONTACT

+8615205140516; huaqingh@advenchen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To maintain study blinding, until the study is completed, it should be Ensure that blinded staff and associated with this trial may not see the random table and treatment group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: February 8, 2024
• Study Start: October 26, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 8, 2024

Record last verified: 2024-01

Locations

CN (1)