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Study on the Safety and Effectiveness of AL8326 for Patients with Small Cell Lung Cancer Needing Second-Line Treatment

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Small Cell Lung Cancer (SCLC), a type of lung cancer that is known for its aggressive nature and rapid growth. The study is evaluating a new medication called AL8326, which is taken in tablet form. This medication is a type of drug known as a receptor kinase inhibitor, which works by blocking certain proteins that help cancer cells grow.

The purpose of the study is to assess the safety and effectiveness of AL8326 in patients who need a second or later line of treatment for Small Cell Lung Cancer. This includes patients whose cancer has spread to the brain, as long as the brain metastasis is controlled and not causing active bleeding. The study aims to find the best dose of the medication that balances effectiveness and safety.

Participants in the study will receive AL8326 and will be monitored over a period of time to observe how well the drug works and to check for any side effects. Some participants may receive a placebo for comparison. The study will help determine the optimal dose and gather information on how the drug affects the body, which will be useful for future treatments of Small Cell Lung Cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, performance status, and confirmation of small cell lung cancer (SCLC) diagnosis.
A measurable lesion must be present, and life expectancy should be at least three months.
Step 2
Treatment initiation
The treatment involves the administration of the drug AL8326 in tablet form.
The medication is taken orally. The specific dosage and frequency are determined based on the optimal biological dose (OBD) identified during the trial.
Step 3
Monitoring and evaluation
Regular monitoring is conducted to evaluate the safety and efficacy of the treatment. This includes assessing the overall response rate (ORR) and other pharmacokinetic parameters.
The duration of response (DOR) and progression-free survival (PFS) are also measured.
Step 4
Completion of treatment
The trial is estimated to conclude by February 11, 2036. The treatment continues until the end of the study or until it is deemed necessary to stop for safety or efficacy reasons.

Who can join the trial?

5 criteria

Must be a male or female who is 18 years of age or older.
Must have an ECOG performance status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some restrictions but still able to do light work.
Must have a confirmed diagnosis of Small Cell Lung Cancer (SCLC) through tests like a biopsy.
Must have at least one measurable lesion, which is a tumor that can be measured in size using specific guidelines called RECIST 1.1.
Must have a life expectancy of at least 3 months.

Who cannot join the trial?

3 criteria

Patients with **uncontrolled brain metastasis**. This means that if cancer has spread to the brain and is not stable or controlled, the patient cannot participate.
Patients with **active hemorrhage**. This refers to ongoing bleeding that is not controlled.
Patients who do not need a **second or more line of treatment**. This means if the patient is not in need of further treatment beyond the first one, they cannot join the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy
Responsive
Istituto Oncologico Veneto
Padua, Italy

Trial locations

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Investigated drugs

AL8326 is an investigational medication being studied for its potential to treat small cell lung cancer (SCLC) in patients who have already received at least one prior treatment. The trial aims to evaluate the safety and effectiveness of this medication to determine the best dose that provides the most benefit with the least side effects.

Al8326

What is already known about the treatment

AL8326 – This medication is administered orally and is currently being evaluated in clinical trials for its safety and effectiveness in treating small cell lung cancer (SCLC), particularly for patients requiring second-line treatment. It is still under investigation, and its status in medical literature is primarily within the context of ongoing research. The main therapeutic indication for AL8326 is for SCLC patients, including those with brain metastasis that is controlled and without active bleeding. The drug works at the molecular level by targeting specific pathways involved in cancer cell growth and survival, although the exact mechanism is still being studied. AL8326 is classified pharmacologically as an investigational anti-cancer agent.

Investigated diseases

Small Cell Lung Cancer – This is a type of lung cancer characterized by small cells that multiply quickly and form large tumors. It often starts in the bronchi, which are the main airways of the lungs, and can spread rapidly to other parts of the body, including the brain. The disease is known for its aggressive nature and is usually diagnosed at an advanced stage. It is divided into two stages: limited stage, where cancer is confined to one lung and nearby lymph nodes, and extensive stage, where it has spread beyond that. Small Cell Lung Cancer is less common than non-small cell lung cancer but is more aggressive. It often requires multiple lines of treatment due to its tendency to recur.