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NCT04010357 · ClinicalTrials.gov registry record · Phase 2
Targeted Therapy With CDK4/6 Inhibitors in Chemo-Refractory, Rb Wild-Type Extensive SCLC
A Phase 2 study of Small-cell Lung Cancer and Large Cell Neuroendocrine Carcinoma of the Lung, sponsored by Case Comprehensive Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT04010357: Active Phase 2 study of Small-cell Lung Cancer and Large Cell Neuroendocrine Carcinoma of the Lung, sponsored by Case Comprehensive Cancer Center.
NCT04010357 is a Phase 2 study of Small-cell Lung Cancer and Large Cell Neuroendocrine Carcinoma of the Lung that is active but no longer recruiting, run by Case Comprehensive Cancer Center. The registered enrollment target is 14 participants, below the 232-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04010357, a Phase 2 study of Small-cell Lung Cancer and Large Cell Neuroendocrine Carcinoma of the Lung, is active but no longer recruiting, sponsored by Case Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to: * Test how well the study medicine Abemaciclib, a CDK4/6 inhibitor, works to shrink lung cancer tumors in the body. * Test the safety of Abemaciclib when given to participants with small cell lung cancer (SCLC), large cell neuroendocrine lung cancer, extrapulmonary small cell cancers and other high grade neuroendocrine cancers of the lung. Specifically, this study is looking at SCLC, large cell neuroendocrine lung cancer, extrapulmonary small cell cancers and other high grade neuroendocrine cancers of the lung that have not responded to treatment (refractory) or come back after treatment with chemotherapy (relapsed) as the study medication has been shown to be effective any time the disease relapses not just in the first few months.
Primary Outcome
Overall Response Rate (ORR) defined as the proportion of subjects in the analysis population who have complete response (CR) or partial response (PR) using RECIST 1.1 criteria at any time during the study. Response for the primary analyses will be determined by independent radiology review. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of tar
Conditions Studied
Interventions
- DRUG Abemaciclib,
Study Locations (1)
Ohio
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-01-13 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT04010357 still lists
NCT04010357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 232-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Abemaciclib, is the first listed.
NCT04010357 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04010357 about?
NCT04010357 is a clinical study titled "Targeted Therapy With CDK4/6 Inhibitors in Chemo-Refractory, Rb Wild-Type Extensive SCLC". The purpose of this study is to: * Test how well the study medicine Abemaciclib, a CDK4/6 inhibitor, works to shrink lung cancer tumors in the body. * Test the safety of Abemaciclib when given to participants with small cell lung cancer (SCLC), large cell neuroendocrine lung cancer, extrapulmonary ...
What is the current status of trial NCT04010357?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2020-01-13. Estimated completion is 2025-12.
What conditions does trial NCT04010357 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer, Large Cell Neuroendocrine Carcinoma of the Lung, Extrapulmonary Small Cell Carcinoma.
What interventions are being tested in trial NCT04010357?
The interventions under investigation include: Abemaciclib, (DRUG).
Who is sponsoring clinical trial NCT04010357?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04010357 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04010357's enrollment target sits among peer trials
14 78th of 79 higher than 2 of 79 other Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
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