Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06095505 · ClinicalTrials.gov registry record · Phase 2
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
A Phase 2 study of Small-cell Lung Cancer, sponsored by Puma Biotechnology.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 20
- Study locations
NCT06095505: Recruiting Phase 2 study of Small-cell Lung Cancer, sponsored by Puma Biotechnology.
NCT06095505 is a Phase 2 study of Small-cell Lung Cancer that is actively recruiting participants, run by Puma Biotechnology. The registered enrollment target is 80 participants, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06095505, a Phase 2 study of Small-cell Lung Cancer, is actively recruiting participants, sponsored by Puma Biotechnology.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 20
- Study locations
Study 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 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy. 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.
Primary Outcome
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study
Conditions Studied
Interventions
- DRUG Alisertib
Study Locations (20)
Ohio
- Oncology Hematology Care Clinical Trials - Cincinnati
- University Hospital - Cleveland Medical Center - Cleveland
- Cleveland Clinic - Cleveland
- Zangmeister Cancer Center - Columbus
Florida
- Clermont Oncology Center - Clermont
- The Oncology Institute of Hope and Innovation - Fort Lauderdale
- Moffitt Cancer Center - Tampa
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana Farber Cancer Institute - Boston
Alabama
- Southern Cancer Center - Daphne
California
- The Oncology Institute of Hope and Innovation - Long Beach
Colorado
- Rocky Mountain Cancer Centers - Lone Tree
District of Columbia
- Georgetown Lombardi Cancer Center - Washington D.C.
Illinois
- Illinois Cancer Specialists - Niles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-02-08 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 2 |
What NCT06095505 shows while recruiting
NCT06095505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Alisertib is the first listed.
NCT06095505 names 20 study sites across 14 states, led by Ohio, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06095505 about?
NCT06095505 is a clinical study titled "A 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 immunotherapy agent. Up to one additional systemic anti-cancer the...
What is the current status of trial NCT06095505?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2024-02-08. Estimated completion is 2027-10-31.
What conditions does trial NCT06095505 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer.
What interventions are being tested in trial NCT06095505?
The interventions under investigation include: Alisertib (DRUG).
Who is sponsoring clinical trial NCT06095505?
This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06095505 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Small-cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06095505's enrollment target sits among peer trials
80 40th of 79 higher than 40 of 79 other Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small-cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer
RECRUITING · Phase 2
-
Durvalumab and Ablative Radiation in Small Cell Lung Cancer (DARES)
RECRUITING · Phase 2
-
Study of Trilaciclib and Lurbinectidin
RECRUITING · Phase 2
-
Phase 2 Study of Fingolimod in Lung Cancers
RECRUITING · Phase 2
-
A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain
RECRUITING · Phase 2
-
Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01243931 · 80 participants · NA
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
- NCT01659203 · 80 participants · Phase 1
Proton or Photon RT for Retroperitoneal Sarcomas
- NCT01803451 · 80 participants · Early Phase 1
Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
- NCT01964859 · 80 participants · Phase 2
Feasibility Study for Fibroblast Autologous Skin Grafts
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI