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New hope for tough lung cancer: targeted pill alisertib under study

NCT ID NCT06095505

Disease control Sponsor: Puma Biotechnology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 18, 2026 · Updated 4 times

Summary

This Phase 2 trial tests the drug alisertib in 120 people with extensive stage small cell lung cancer that has worsened after standard treatments like chemotherapy and immunotherapy. The goal is to see if alisertib can shrink tumors or slow the disease, and to identify which patients might benefit most based on specific biomarkers. Participants take alisertib tablets and are monitored for response and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Alisertib (a targeted cancer drug taken as a tablet)
What this could lead to
If successful, this could provide a new treatment option for people with small cell lung cancer whose disease has progressed after standard therapies.
What could go wrong
This is a Phase 2 trial with only 120 participants, so results are preliminary. The drug may not work for all patients, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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/PD-1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens 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.

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Clermont Oncology Center

    RECRUITING

    Clermont, Florida, 64711, United States

  • Cleveland Clinic

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Georgetown Lombardi Cancer Center

    RECRUITING

    Washington D.C., District of Columbia, 20057, United States

  • Henry Ford Hospital

    COMPLETED

    Detroit, Michigan, 48202, United States

  • Illinois Cancer Specialists

    RECRUITING

    Niles, Illinois, 60714, United States

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Marshfield Medical Center

    RECRUITING

    Marshfield, Wisconsin, 54449, United States

  • Medical University of South Carolina Hollings Cancer Center

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Minnesota Oncology Hematology

    RECRUITING

    Burnsville, Minnesota, 55337, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Nebraska Cancer Specialists

    RECRUITING

    Grand Island, Nebraska, 68803, United States

  • Northwest Cancer Specialists

    RECRUITING

    Vancouver, Washington, 98686, United States

  • Oncology & Hematology Associates of Southwest Virginia

    RECRUITING

    Blacksburg, Virginia, 24073, United States

  • Oncology Associates of Oregon

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Oncology Hematology Care Clinical Trials

    RECRUITING

    Cincinnati, Ohio, 45226, United States

  • Rocky Mountain Cancer Centers

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Southern Cancer Center

    RECRUITING

    Daphne, Alabama, 36526, United States

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • The Oncology Institute of Hope and Innovation

    RECRUITING

    Long Beach, California, 90805, United States

  • The Oncology Institute of Hope and Innovation

    RECRUITING

    Fort Lauderdale, Florida, 33316, United States

  • UPMC Hillman Cancer Center

    WITHDRAWN

    Pittsburgh, Pennsylvania, 15232, United States

  • University Hospital - Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Maryland Greenebaum Comprehensive Cancer Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Universtity of Virginia Health System

    COMPLETED

    Charlottesville, Virginia, 22908, United States

  • Virginia Cancer Specialists Research Institute

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Zangmeister Cancer Center

    RECRUITING

    Columbus, Ohio, 43219, United States

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