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

1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Hospital Universitario Ramon Y Cajal Madrid Spain
Universita’ Campus Bio-medico Di Roma Rome Italy
Hospital Clinic De Barcelona Barcelona Spain
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Htxlbjfu Vfej dqimfdjc Barcelona Spain
Hnvgjvdc Ulwhionkxoewt di A Cobrxz A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
09.09.2024
Spain Spain
Not yet recruiting
09.09.2024

Trial locations

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.

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 ID:
2023-509067-24-00
Protocol code:
AL8326-US-001
NCT ID:
NCT05363280
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A study to investigate the safety and effects of ceralasertib, tremelimumab, and durvalumab in adults with various solid tumors

    Recruiting

    1 1 1
    Poland
  • A study of ABBV-706 and atezolizumab for patients with previously untreated extensive stage small cell lung cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Belgium Germany Italy Poland Spain