A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)
A Phase 2 Study of Alisertib in Combination With Paclitaxel in Patients With Small Cell Lung Cancer
- Small Cell Lung Cancer ( SCLC )
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Puma Biotechnology, Inc.
- Enrolment target
- 50
- Started
- 17 September 2026
- Main results due
- 31 March 2028
- Study sites
- 6
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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-1/PD-L1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to 2 prior treatment regimens * Measurable disease as defined by RECIST v1.1 Exclusion Criteria: * Prior treatment with an aurora kinase A (AURKA) specific-targeted or pan-Aurora- targeted agent, including alisertib, in any setting There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
What this study is about
In the sponsor’s own words, from the registry.
The goal of this clinical trial is to determine how well people tolerate treatment with alisertib at different doses when it is used together with paclitaxel to treat people with SCLC. The main question it aims to answer is:
* What percentage of side effects, both mild and serious, do participants experience when being treated with alisertib and paclitaxel based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v.5.0)?
The study will consist of different groups, called cohorts, in which alisertib will be studied at increasing doses. Participants in the first group, Cohort 1, will take 30 mg of alisertib by mouth 2 times a day. The dose will increase by 10 mg 2 times a day for each new cohort of participants joining the study. Side effects will be checked during the study, and the decision to increase the dose of alisertib will be based on the specific side effects experienced during the first 21 days of treatment for each cohort.
Participants will:
* take alisertib by mouth on their own 2 times a day from Day 1 through Day 7 of each 21-day cycle and will be given paclitaxel intravenously at a dose of 60 mg/m2 on Day 1 and Day 8 of each 21-day cycle. * be given a preventive treatment to increase their body defenses, called granulocyte-colony stimulating factor (G-CSF). Study staff will give G-CSF after the last dose of alisertib or paclitaxel of each 21-day cycle in which alisertib was given. * provide blood samples to evaluate the different levels of alisertib in the blood at different times. Blood samples will be collected on Days 1 and 7 of the first and second 21-day cycles of treatment. * be treated with alisertib and paclitaxel until death, worsening of the disease, unacceptable toxicity, unwillingness to continue participating in the trial, or other criteria that requires participants to stop treatment and participation in the study. * be contacted every 8 weeks after stopping alisertib and paclitaxel treatment as part of a specific study phase called the long-term follow-up period. This will last until death, unwillingness to continue participating in the trial, or until the end of the study.
Study sites(6)
Hospital General Universitario Dr. Balmis
Alicante, Spain
Recruiting
Hospital Quiron Dexeus
Barcelona, Spain
Recruiting
START Barcelona - HM Nou Delfos
Barcelona, Spain
Recruiting
START Rioja - Hospital de San Pedro
Logroño, Spain
Recruiting
Hospital Universitario Morales Meseguer
Murcia, Spain
Recruiting
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Spain
Recruiting
Showing 6 of 6 sites. 6 of the 6 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07465757. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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