Our Mission
Puma Biotechnology is a biopharmaceutical company dedicated to the acquisition, development, and commercialization of novel therapeutics for the treatment of cancer.
Clinical Trials
ALISCA®-Lung2
In September 2023, the FDA granted Orphan Drug Designation to alisertib, a selective, small-molecule, orally administered inhibitor of Aurora Kinase A, for the treatment of patients with small cell lung cancer SCLC. The FDA grants Orphan Drug Designation to investigational therapies being developed to treat, diagnose, or prevent a rare disease or condition affecting fewer than 200,000 people in the United States. In February of 2024, Puma initiated ALISCA®-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with small cell lung cancer. In August 2026, Puma initiated ALISCA®-Lung2, a Phase II clinical trial of alisertib in combination with paclitaxel for the treatment of patients with small cell lung cancer.
Small Cell Lung Cancer
ALISCA®-Lung2
A Phase II Study of Alisertib, an Investigational Drug, in Combination with Paclitaxel in Patients with Small Cell Lung Cancer
ABOUT THIS CLINICAL TRIAL
This is a multi-center Phase II open label study (PUMA-ALI-4202) evaluating increasing doses of alisertib administered in combination with paclitaxel in patients with SCLC. The objectives of the study are to assess the safety and tolerability of various doses of alisertib in combination with paclitaxel as well as evaluate clinical effectiveness. Exploratory objectives include evaluating biomarkers of interest in both tumor and liquid biopsies.
WHO IS ELIGIBLE?
The ALISCA®-Lung2 clinical trial is open to patients 18 years or older with pathologically confirmed SCLC following progression on or after treatment with up to two prior treatment regimens. Patients must have received treatment with one platinum-based chemotherapy and immunotherapy. Talk to your doctor to discuss your eligibility.
NOW ENROLLING
Puma anticipates opening the ALISCA®-Lung2 trial at approximately 30 study sites within the United States and Europe.
Click here for a list of US study sites currently open to enrollment
Click here for a list of European study sites currently open to enrollment
or email clinicaltrials@pumabiotechnology.com
Ask Puma
Have questions about Puma’s ALISCA®-Lung2 clinical trial? Our Clinical Trials Team is here to help. You can email your questions directly to our experts to get the information you need. Click our “Ask Puma” button to send your email now.
