NCT06095505 A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
| NCT ID | NCT06095505 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Puma Biotechnology, Inc. |
| Condition | Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-02-08 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2024-02-08 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
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-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.
Contact & Investigator
Puma Biotechnology, Inc. Clinical Operations Senior Director
✉ ClinicalTrials@pumabiotechnology.com📞 (424) 248-6500
Chief Scientific Officer
STUDY DIRECTOR
Puma Biotechnology, Inc.
Frequently Asked Questions
Who can join the NCT06095505 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06095505 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06095505 currently recruiting?
Yes, NCT06095505 is actively recruiting participants. Contact the research team at ClinicalTrials@pumabiotechnology.com for enrollment information.
Where is the NCT06095505 trial being conducted?
This trial is being conducted at Daphne, United States, Long Beach, United States, Lone Tree, United States, Washington D.C., United States and 11 additional locations.
Who is sponsoring the NCT06095505 clinical trial?
NCT06095505 is sponsored by Puma Biotechnology, Inc.. The principal investigator is Chief Scientific Officer at Puma Biotechnology, Inc.. The trial plans to enroll 120 participants.
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