What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy regimens such as etoposide with cisplatin or carboplatin, immune checkpoint inhibitors, and multi-targeted receptor Tyrosine Kinase Inhibitors (TKIs) like AL8326. Known side effects of these treatments often include gastrointestinal issues (nausea, vomiting, diarrhea), hematologic toxicities (neutropenia, anemia), fatigue, and liver enzyme elevation. TKIs specifically can also cause interstitial lung disease and other severe effects.

What prior FDA approvals exist?

FDA-approved treatments for Small Cell Lung Cancer (SCLC) include various chemotherapy regimens and immunotherapies. While specific multi-targeted receptor Tyrosine Kinase Inhibitors (TKIs) like AL8326 are not mentioned, other treatments such as nivolumab, an immune checkpoint inhibitor, have been approved for relapsed SCLC. Additionally, standard chemotherapy agents like etoposide, carboplatin, and cisplatin are commonly used in treatment protocols. The approval of these therapies highlights the ongoing efforts to improve outcomes for patients with SCLC through diverse mechanisms of action.

What other types of research exist?

Promising novel alternatives to AL8326 for Small Cell Lung Cancer patients include Lorlatinib, which has shown activity in ALK-positive NSCLC and may have potential in SCLC due to its efficacy in overcoming resistance to prior ALK inhibitors. Additionally, dual inhibitors targeting ALK and other pathways (e.g., EGFR, TRK, FAK, ROS1) such as AP26113, TSR011, CEP-37440, and RXDX-101 are under active clinical development and may offer new therapeutic options.

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Tyrosine Kinase Inhibitor

AL8326 for Small Cell Lung Cancer

Phase 2

Recruiting

Led By Saiama Waqar, MD

Research Sponsored by Advenchen Pharmaceuticals, LLC.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed SCLC

ECOG performance status of 0 or 1

Must not have

Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels

Serious, non-healing wound, ulcer or bone fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of AL8326, a medication taken by mouth, in patients with advanced small cell lung cancer who need additional treatment. The drug works by blocking proteins that help cancer cells grow.

Who is the study for?

This trial is for adults over 18 with small cell lung cancer (SCLC) who need second or later line treatment. They should have a life expectancy of at least 3 months, be able to perform daily activities with minimal assistance (ECOG status 0-1), and have measurable cancer lesions. Excluded are those with high bleeding risks, recent hemoptysis, unhealed wounds/fractures, major surgery within the past month, serious heart conditions, or using certain drugs affecting liver enzymes.

What is being tested?

The trial tests three different doses of AL8326 oral medication on patients with recurrent or advanced SCLC. AL8326 is a multi-targeted receptor Tyrosine Kinase Inhibitor (TKI). The goal is to find out how safe it is and how well it works in controlling the disease after first-line treatments haven't worked.

What are the potential side effects?

While specific side effects for AL8326 aren't listed here, similar medications often cause fatigue, nausea, diarrhea, blood pressure changes and risk of bleeding. Side effects can vary based on dose and individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed as small cell lung cancer through testing.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have conditions that increase my risk of bleeding significantly.

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I have a serious wound, ulcer, or bone fracture that isn't healing.

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I do not have serious heart or blood vessel problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rates (ORR)

Optimal biological dose ( OBD )

Secondary study objectives

Duration of response ( DOR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: OBD finding cohort at middle doseExperimental Treatment1 Intervention

Subject in middle dose group will receive AL8326 orally in each cycle until intolerable toxicity or disease progression or withdrawal . 6-12 subjects are in this group. Efficacy, safety and PK will be evaluated and compared within 3 different dosing group to define the final OBD.

Group II: OBD finding cohort at low doseExperimental Treatment1 Intervention

Subject in low dose group will receive AL8326 orally in each cycle until intolerable toxicity or disease progression or withdrawal . 6-12 subjects are in this group. Efficacy, safety and PK will be evaluated and compared within 3 different dosing group to define the final OBD.

Group III: OBD finding cohort at high doseExperimental Treatment1 Intervention

Subject in high dose group will receive AL8326 orally in each cycle until intolerable toxicity or disease progression or withdrawal . 6-12 subjects are in this group. Efficacy, safety and PK will be evaluated and compared within 3 different dosing group to define the final OBD.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Small Cell Lung Cancer (SCLC) is typically treated with a combination of chemotherapy and radiation therapy due to its aggressive nature and tendency to spread quickly. Chemotherapy works by targeting rapidly dividing cancer cells, while radiation therapy uses high-energy rays to kill cancer cells and shrink tumors. Recently, targeted therapies such as multi-targeted receptor Tyrosine Kinase Inhibitors (TKIs) have shown promise. These TKIs, including those similar to AL8326, work by blocking specific enzymes (tyrosine kinases) involved in the growth and spread of cancer cells. This targeted approach can potentially reduce side effects and improve efficacy compared to traditional treatments, offering new hope for SCLC patients.

Targeted Approaches Applied to Uncommon Diseases: A Case of Salivary Duct Carcinoma Metastatic to the Brain Treated with the Multikinase Inhibitor Neratinib.Caspase-9b Interacts Directly with cIAP1 to Drive Agonist-Independent Activation of NF-κB and Lung Tumorigenesis.Overcoming resistance to tyrosine kinase inhibitors in renal cell carcinoma.