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NCT05142696 · ClinicalTrials.gov registry record · Phase 1
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab
A Phase 1 study of Extensive-stage Small-cell Lung Cancer, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 20
- Study locations
NCT05142696: Active Phase 1 study of Extensive-stage Small-cell Lung Cancer, sponsored by Novartis Pharmaceuticals.
NCT05142696 is a Phase 1 study of Extensive-stage Small-cell Lung Cancer that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 24 participants, below the 175-participant average among 25 other Extensive-stage Small-cell Lung Cancer trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05142696, a Phase 1 study of Extensive-stage Small-cell Lung Cancer, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study aims to establish a safe and well tolerated dose of \[177Lu\]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications with an onset within the first cycle of initiation of \[177Lu\]Lu-DOTA-TATE treatment. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for AE grading.
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG [177Lu]Lu-DOTA-TATE
- DRUG [68Ga]Ga-DOTA-TATE
- OTHER Carboplatin
- OTHER Etoposide
Study Locations (20)
Other
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Shanghai
- Novartis Investigative Site - Olomouc
- Novartis Investigative Site - Bron
- Novartis Investigative Site - Lille
- Novartis Investigative Site - Marseille
- Novartis Investigative Site - Montpellier
District of Columbia
- Georgetown University Lombardi Cancer Center - Washington D.C.
Florida
- Advent Health Cancer Institute - Orlando
Georgia
- University Cancer and Blood Center LLC - Athens
Kentucky
- University of Kentucky - Lexington
Missouri
- St. Louis University - St Louis
New Jersey
- Hackensack Meridian Health - Edison
Ohio
- University Hospitals Of Cleveland - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2029-03-23 |
| Phase | Phase 1 |
What the registry record for NCT05142696 still lists
NCT05142696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 175-participant average among 25 other Extensive-stage Small-cell Lung Cancer trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Extensive-stage Small-cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Atezolizumab is the first listed.
NCT05142696 names 20 study sites across 13 states, led by Other, District of Columbia, Florida.
Frequently Asked Questions
What is clinical trial NCT05142696 about?
NCT05142696 is a clinical study titled "A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab". This study aims to establish a safe and well tolerated dose of \[177Lu\]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The stu...
What is the current status of trial NCT05142696?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-07-13. Estimated completion is 2029-03-23.
What conditions does trial NCT05142696 study?
This clinical trial studies the following conditions: Extensive-stage Small-cell Lung Cancer.
What interventions are being tested in trial NCT05142696?
The interventions under investigation include: Atezolizumab (DRUG), [177Lu]Lu-DOTA-TATE (DRUG), [68Ga]Ga-DOTA-TATE (DRUG), Carboplatin (OTHER), Etoposide (OTHER).
Who is sponsoring clinical trial NCT05142696?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05142696 being conducted?
This trial has 20 study locations across District of Columbia, Florida, Georgia, Kentucky, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05142696's enrollment target sits among peer trials
24 21st of 25 higher than 4 of 25 other Extensive-stage Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Extensive-stage 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.
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