Small Cell Lung CancerPhase 2ALISCA-Lung1NCT06095505
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
A Phase 2 study testing Alisertib in people with Small Cell Lung Cancer, run by Puma Biotechnology, Inc. at 30 sites in United States.
Trial summary
PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1/PD-1 immunotherapy agent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Alisertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 30 sitesUnited States
- Study dates
- 8 Feb 2024to 30 Apr 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-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
Who cannot join
- 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.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Puma Biotechnology, Inc. Clinical Operations Senior Director contact
30 sites in 1 country
United States30 sites, 26 recruiting
- Recruiting
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
- Recruiting
Oncology & Hematology Associates of Southwest Virginia
Blacksburg, Virginia, 24073
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Minnesota Oncology Hematology
Burnsville, Minnesota, 55337
- Recruiting
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425
- Completed
Universtity of Virginia Health System
Charlottesville, Virginia, 22908
- Recruiting
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, 45226
- Recruiting
Clermont Oncology Center
Clermont, Florida, 64711
- Recruiting
University Hospital - Cleveland Medical Center
Cleveland, Ohio, 44106
- Active, not recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Zangmeister Cancer Center
Columbus, Ohio, 43219
- Recruiting
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Southern Cancer Center
Daphne, Alabama, 36526
- Completed
Henry Ford Hospital
Detroit, Michigan, 48202
- Recruiting
Oncology Associates of Oregon
Eugene, Oregon, 97401
- Recruiting
Virginia Cancer Specialists Research Institute
Fairfax, Virginia, 22031
- Recruiting
The Oncology Institute of Hope and Innovation
Fort Lauderdale, Florida, 33316
- Recruiting
Nebraska Cancer Specialists
Grand Island, Nebraska, 68803
- Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
- Recruiting
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124
- Recruiting
The Oncology Institute of Hope and Innovation
Long Beach, California, 90805
- Recruiting
Marshfield Medical Center
Marshfield, Wisconsin, 54449
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Illinois Cancer Specialists
Niles, Illinois, 60714
- Withdrawn
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
- Recruiting
Northwest Cancer Specialists
Vancouver, Washington, 98686
- Recruiting
Georgetown Lombardi Cancer Center
Washington D.C., District of Columbia, 20057
About this study
Official title: A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1/PD-1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Alisertib
- 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
| Study group | Role | What they receive |
|---|---|---|
| Alisertib | Experimental | 50 mg (Prior to Amendment 2) or 60 mg (Amendment 2) or 70 mg (Amendment 3 or later) of alisertib PO BID on days 1-7 of each 21-day cycle Receives: Drug: Alisertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) within biomarker-defined subgroup
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study
Measured: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
Duration of response (DOR) within biomarker-defined subgroup
Duration of response is measured from the time at which measurement criteria are first met for CR or PR (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 (after date of first dose) to first PD, assessed up to 36 months
Disease Control Rate (DCR) within biomarker-defined subgroup
Disease control rate is the proportion of patients who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 8 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 36 months
Progression Free Survival (PFS) within biomarker-defined subgroup
Progression Free Survival (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 36 months
Overall Survival (OS) within biomarker-defined subgroup
Overall survival (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 36 months
Secondary outcomes (6)
Objective response rate (ORR) in the enrolled patient population
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study.
Measured: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
Duration of response (DOR) in the enrolled patient population
Duration of response is measured from the time at which measurement criteria are first met for CR or PR (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 (after date of first dose) to first PD, assessed up to 36 months
Disease Control Rate (DCR) in the enrolled patient population
Disease control rate is the proportion of patients who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 8 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 36 months
Progression Free Survival (PFS) in the enrolled patient population
Progression Free Survival (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 36 months
Overall Survival (OS) in the enrolled patient population
Overall survival (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 36 months
Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the enrolled patient population
Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after last dose.
Measured: From date of first dose through last dose plus 28 days, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start8 Feb 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puma Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Scientific Officer, Study director, Puma Biotechnology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095505
- Sponsor's protocol ID
- PUMA-ALI-4201
- Acronym
- ALISCA-Lung1
- Status last verified
- Aug 2026
- First submitted
- 27 Sep 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06095505
- Acronym / sponsor ID
- ALISCA-Lung1 / PUMA-ALI-4201
- Conditions
- Small Cell Lung Cancer
- Keywords
- Alisertib, SCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Puma Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1/PD-1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alisertib | Experimental | Drug: Alisertib50 mg (Prior to Amendment 2) or 60 mg (Amendment 2) or 70 mg (Amendment 3 or later) of alisertib PO BID on days 1-7 of each 21-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlisertibAlso: PB-8237, MLN8237Alisertib enteric-coated tablets | Drug | Alisertib |
Primary outcome
Objective response rate (ORR) within biomarker-defined subgroup
Time frame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study
Duration of response (DOR) within biomarker-defined subgroup
Time frame: From start date of response (after date of first dose) to first PD, assessed up to 36 months
Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented.
Disease Control Rate (DCR) within biomarker-defined subgroup
Time frame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
Disease control rate is the proportion of patients who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 8 weeks from first dose of investigational product.
Progression Free Survival (PFS) within biomarker-defined subgroup
Time frame: From date of first dose to date of recurrence, progression or death, assessed up to 36 months
Progression Free Survival (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.
Overall Survival (OS) within biomarker-defined subgroup
Time frame: From date of first dose to death, assessed up to 36 months
Overall survival (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.
6 secondary outcomes
Objective response rate (ORR) in the enrolled patient population
Time frame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
Duration of response (DOR) in the enrolled patient population
Time frame: From start date of response (after date of first dose) to first PD, assessed up to 36 months
Disease Control Rate (DCR) in the enrolled patient population
Time frame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
Progression Free Survival (PFS) in the enrolled patient population
Time frame: From date of first dose to date of recurrence, progression or death, assessed up to 36 months
Overall Survival (OS) in the enrolled patient population
Time frame: From date of first dose to death, assessed up to 36 months
Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the enrolled patient population
Time frame: From date of first dose through last dose plus 28 days, assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Puma Biotechnology, Inc. Clinical Operations Senior Director contact
Chief Scientific Officer study director
Puma Biotechnology, Inc.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alisertib in people with Small Cell Lung Cancer, run by Puma Biotechnology, Inc. at 30 sites in United States.
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 3 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. 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?
Objective response rate (ORR) within biomarker-defined subgroup (time frame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.