Phase 2 Study on the Safety and Effectiveness of AL8326 for Second-Line Treatment in Small Cell Lung Cancer

Sponsor: Advenchen Pharmaceuticals, LLC.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05363280

Provider View

This clinical trial is testing a new oral medication, AL8326, to see if it is safe and effective for patients with advanced small cell lung cancer (SCLC) who need a second or later line of treatment.

Patient Parameters

Program Overview

The study is focused on evaluating the safety and effectiveness of AL8326, a new oral medication, for patients with advanced small cell lung cancer (SCLC) who have already received at least one prior treatment. The trial is divided into two parts: finding the best dose of the medication and then expanding the study to more patients to further assess its safety and effectiveness.

Description

This clinical trial is being conducted in two main steps. The first step is to find the best dose of AL8326, a new medication for small cell lung cancer (SCLC). Patients will be randomly assigned to one of three different dose groups to determine the optimal dose. Each group will include 6-12 patients who need a second or later line of treatment, and who may have brain metastases that are stable and not actively bleeding. This part of the study will also look at how the body processes the medication.

If the results from the first step are positive, the study will expand to include 40-60 more patients to further evaluate the safety and effectiveness of AL8326. This expanded study will continue to focus on patients with SCLC who need additional treatment and have stable brain metastases. The expansion will proceed with approval from the FDA.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have a confirmed diagnosis of small cell lung cancer (SCLC).
  • Have at least one measurable tumor based on standard criteria.
  • Have a life expectancy of at least 3 months.

Exclusion Criteria

  • Have a serious, non-healing wound, ulcer, or bone fracture.
  • Have had major surgery within the last 28 days or minor surgery within the last 7 days before starting treatment.
  • Have active bleeding or conditions that increase the risk of bleeding, such as bleeding disorders or tumors involving major blood vessels.
  • Have significant heart disease, including uncontrolled high blood pressure, recent heart attack, or serious heart rhythm problems.
  • Have coughed up blood within the last 3 months.
  • Are taking certain medications that affect liver enzymes within 14 days before starting the study, unless needed for an emergency or life-threatening condition.

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