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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 often requires additional treatment after the first round of therapy. The study will use a medication called AL8326, which is a type of drug known as a receptor kinase inhibitor. This medication is taken in the form of a tablet. The purpose of the study is to evaluate the safety and effectiveness of AL8326 for patients who need further treatment for SCLC, especially those who have controlled brain metastasis, meaning the cancer has spread to the brain but is not actively causing bleeding.

Participants in the study will receive AL8326 as a second-line treatment, which means it is given after the initial treatment has been completed. The study will explore different doses of the medication to find the best balance between effectiveness and safety. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects. The study will last for a period of up to 12 months, during which the health and response of the participants will be closely monitored.

The trial aims to determine the optimal dose of AL8326 that provides the best results for patients with SCLC. This includes looking at how well the cancer responds to the treatment and how long the benefits last. The study will also gather information on how the body processes the medication and any potential side effects. This research is important for improving treatment options for patients with Small Cell Lung Cancer who need further therapy after their initial treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, performance status, and confirmed diagnosis of small cell lung cancer (SCLC).

    The patient must have at least one measurable lesion and a life expectancy of at least three months.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of the drug AL8326 in tablet form.

    The drug is taken orally. The specific dosage and frequency are determined based on the optimal biological dose (OBD) identified during the trial.

  3. Step 3

    Monitoring and assessment

    Regular monitoring is conducted to assess the safety and efficacy of the treatment.

    This includes evaluating the overall response rate (ORR) and other pharmacokinetic parameters such as maximum concentration (Cmax) and area under the curve (AUC).

  4. Step 4

    Evaluation of treatment response

    The duration of response (DOR) and progression-free survival (PFS) are measured to determine the effectiveness of the treatment.

    The relationship between pharmacokinetics, pharmacodynamics, efficacy, and safety is analyzed.

  5. Step 5

    Completion of trial participation

    The trial is estimated to conclude by September 10, 2035.

    Upon completion, the data collected will contribute to understanding the optimal use of AL8326 for SCLC treatment.

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 person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • Must have a confirmed diagnosis of Small Cell Lung Cancer (SCLC) through specific medical tests.
  • Must have at least one measurable lesion, which is a tumor that can be measured in size, as defined by a set of guidelines called RECIST 1.1.
  • Must have a life expectancy of at least 3 months.

Who cannot join the trial?

5 criteria

  • Patients with **uncontrolled brain metastasis**. This means the cancer has spread to the brain and is not being managed effectively.
  • Patients with **active hemorrhage**. This refers to ongoing bleeding that is not controlled.
  • Patients who have not received at least a **2nd line treatment**. This means they have not tried at least one other treatment after the initial one.
  • Patients who are not within the specified **age range** for the study.
  • Patients who are part of a **vulnerable population**. This includes groups who may need special protection or care.
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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.

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 is for SCLC patients, including those with controlled brain metastasis. AL8326 works by targeting specific molecular pathways involved in cancer cell growth and survival, although the exact mechanism at the molecular level is still being studied. It is classified pharmacologically as an investigational anti-cancer agent.

Investigated diseases

Small Cell Lung Cancer – Small Cell Lung Cancer (SCLC) is a fast-growing type of lung cancer that primarily arises in the bronchi, the main airways of the lungs. It is characterized by small cells that multiply quickly and form large tumors. SCLC often spreads rapidly to other parts of the body, including the brain, liver, and bones. Patients may experience symptoms such as coughing, chest pain, and difficulty breathing. The disease is often diagnosed at an advanced stage due to its aggressive nature. Treatment typically involves multiple lines of therapy, especially when the cancer has metastasized or recurred.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509067-24-00Protocol codeAL8326-US-001Estimated enrolment130 patientsSponsorAdvenchen Pharmaceuticals LLC

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