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Small Cell Lung Cancer ( SCLC )Phase 2ALISCA-Lung2NCT07465757

A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)

A Phase 2 study testing Alisertib and Paclitaxel in people with Small Cell Lung Cancer ( SCLC ), run by Puma Biotechnology, Inc. at 11 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer ( SCLC )
What is being tested?
Alisertib and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
11 sitesin 3 countries
Study dates
17 Sep 2026to 30 Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Puma Biotechnology, Inc. Clinical Operations Senior Director contact

424-248-6500

ClinicalTrials@pumabiotechnology.com

11 sites in 3 countries

Spain9 sites, 9 recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante

    Recruiting

  • Hospital Del Mar

    Barcelona

    Recruiting

  • Hospital Quiron Dexeus

    Barcelona

    Recruiting

  • START Barcelona - HM Nou Delfos

    Barcelona

    Recruiting

  • START Rioja - Hospital de San Pedro

    Logroño

    Recruiting

  • Hospital Regional Universitario de Malaga - General Hospital

    Málaga

    Recruiting

  • Hospital Universitario Morales Meseguer

    Murcia, 30008

    Recruiting

  • Hospital Universitario Infanta Sofía

    San Sebastián de los Reyes

    Recruiting

  • Hospital Universitario Virgen Del Rocío

    Seville

    Recruiting

Other trials in Spain

United States1 site, 1 recruiting

  • Cancer Care Specialists

    Reno, Nevada, 89511

    Recruiting

Other trials in United States

France1 site, 1 recruiting

  • Institut Curie Paris

    Paris

    Recruiting

Other trials in France

About this study

Official title: A Phase 2 Study of Alisertib in Combination With Paclitaxel in Patients With Small Cell Lung Cancer

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)?
Read more

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.
Read the detailed description

This is a Phase 2 open label study evaluating increasing doses of alisertib administered in combination with paclitaxel in patients with pathologically confirmed small cell lung cancer (SCLC) following progression on or after treatment with up to 2 prior treatment regimens. Patients must have received treatment with platinum-based chemotherapy and an anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) immunotherapy agent. Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Starting with alisertib 30 mg twice a day (BID) in Cohort 1 and increasing in each successive cohort by 10 mg BID, each dosing cohort will enroll approximately 10 safety-evaluable patients to assess safety. Toxicity will be assessed throughout the study using NCI CTCAE v5.0, and decisions regarding escalating the alisertib dose will be based on the occurrence of Events during Cycle 1 (Days 1-21) of each dose level. If 3 or fewer patients experience an Event during Cycle 1, then the alisertib dose may be increased by 10 mg BID at the next dose level. It is not anticipated that the planned dosage of alisertib would exceed 70 mg BID. At the time 10 patients have completed Cycle 1 or the maximum number (4) of Events has been reached, whichever is sooner, the Sponsor will hold enrollment until a decision on moving to the next dose level is made.

Being tested
Alisertib, Paclitaxel
Keywords
alisertib, SCLC
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlisertibDrug

    Also called PB-8237, MLN8237

    Alisertib enteric-coated tablets, 30 mg BID self-administered orally on Days 1-7 of every 21-day cycle

  • AlisertibDrug

    Also called PB-8237, MLN8237

    Alisertib enteric-coated tablets, 40 mg BID self-administered orally on Days 1-7 of every 21-day cycle

  • AlisertibDrug

    Also called PB-8237, MLN8237

    Alisertib enteric-coated tablets, 50 mg BID self-administered orally on Days 1-7 of every 21-day cycle

  • AlisertibDrug

    Also called PB-8237, MLN8237

    Alisertib enteric-coated tablets, 60 mg BID self-administered orally on Days 1-7 of every 21-day cycle

  • AlisertibDrug

    Also called PB-8237, MLN8237

    Alisertib enteric-coated tablets, 70 mg BID self-administered orally on Days 1-7 of every 21-day cycle

  • PaclitaxelDrug

    60 mg/m^2 IV on Days 1 and 8 of every 21-day cycle

Study groups in NCT07465757
Study groupRoleWhat they receive
Cohort 1: Alisertib 30 mg BID + PaclitaxelExperimentalApproximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1.
Receives: Drug: Alisertib; Drug: Paclitaxel
Cohort 2: Alisertib 40 mg BID + PaclitaxelExperimentalApproximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1.
Receives: Drug: Alisertib; Drug: Paclitaxel
Cohort 3: Alisertib 50 mg BID + PaclitaxelExperimentalApproximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1.
Receives: Drug: Alisertib; Drug: Paclitaxel
Cohort 4: Alisertib 60 mg BID + PaclitaxelExperimentalApproximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1.
Receives: Drug: Alisertib; Drug: Paclitaxel
Cohort 5: Alisertib 70 mg BID + PaclitaxelExperimentalApproximately ten participants will be enrolled in the cohort.
Receives: Drug: Alisertib; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events)

    Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after the last dose.

    Measured: From date of first dose through last dose plus 28 days, assessed up to 24 months

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants demonstrating a confirmed Complete or Partial Response during the treatment phase of the study.

    Measured: From date of first dose to first confirmed Complete or Partial Response, assessed up to 24 months

  2. Duration of response (DOR)

    DOR is measured from the time at which measurement criteria are first met for confirmed Complete or Partial Response (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented.

    Measured: From start date of response to first PD or death, assessed up to 24 months

  3. Disease Control Rate (DCR)

    DCR is defined as the proportion of patients who achieve overall tumor response (confirmed Complete or Partial Response) or Stable Disease lasting for at least 12 weeks from first dose of investigational product.

    Measured: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 24 months

  4. Progression Free Survival (PFS)

    PFS is measured in months and based on the local tumor assessment. The time interval from the date of first dose until the first date on which recurrence, progression, or death due to any cause, is documented.

    Measured: From date of first dose to date of recurrence, progression or death, assessed up to 24 months

  5. Overall Survival (OS)

    OS is defined as the time from date of first dose to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier.

    Measured: From date of first dose to death, assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study start17 Sep 2026
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07465757
Sponsor's protocol ID
PUMA-ALI-4202
Other IDs
2026-525382-47-00
Acronym
ALISCA-Lung2
Status last verified
Oct 2026
First submitted
6 Mar 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge. In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings. Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information. Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alisertib and Paclitaxel in people with Small Cell Lung Cancer ( SCLC ), run by Puma Biotechnology, Inc. at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Spain, United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Puma Biotechnology, Inc. Clinical Operations Senior Director (424-248-6500, ClinicalTrials@pumabiotechnology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) (time frame: From date of first dose through last dose plus 28 days, assessed up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07465757.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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