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

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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 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.

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.

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.

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.

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 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 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 Study?

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.

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
Istituto Oncologico Veneto	Padua	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hdsnyous Vawh djqjible	Barcelona	Spain
Hjutghnu Ucdrrpvunijym de A Cmgxuk	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	10.02.2025
Spain	Not yet recruiting	10.02.2025

Trial locations

Investigated drugs:

Al8326

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 – 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.

Trial ID:

2023-509067-24-01

Protocol code:

AL8326-US-001

NCT ID:

NCT05363280

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?