A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

Launched by PUMA BIOTECHNOLOGY, INC. · Oct 18, 2023

Keywords

ClinConnect Summary

The PUMA-ALI-4201 clinical trial is studying a medication called alisertib to see how effective it is for patients with extensive stage small cell lung cancer (SCLC) who have already received treatment with a platinum-based chemotherapy and an immunotherapy agent. This trial aims to find out which patients might benefit the most from alisertib and to gather information on its safety and how it works in the body.

To participate in this study, you need to be at least 18 years old and have a confirmed diagnosis of SCLC. You should have received at least one type of platinum chemotherapy and one immunotherapy treatment in the past, although you can have had up to two treatments overall. If you join the trial, you will receive alisertib and will be monitored closely for any side effects and to see how well the treatment is working. It's important to note that if you have already been treated with alisertib or similar medications, you may not be eligible for this study. The study is currently recruiting participants of all genders, so if you think you might qualify, it's worth discussing with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged ≥18 years at signing of informed consent
• • Pathologically confirmed SCLC
• • Prior treatment with one platinum-based chemotherapy and an anti-PD-L1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy
• Exclusion Criteria:
• • Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting
• • Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.