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NCT04256421 · ClinicalTrials.gov registry record · Phase 3
A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
A Phase 3 study of Small-cell Lung Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 490
- Enrollment target
- 20
- Study locations
NCT04256421 is a Phase 3 study of Small-cell Lung Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 490 participants, above the 226-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (117% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT04256421, a Phase 3 study of Small-cell Lung Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 490 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (\</= upper limit of normal \[ULN\] vs. \> ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase: * Arm A: Tiragolumab plus atezolizumab plus CE * Arm B: Placebo plus atezolizumab plus CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Placebo
- DRUG Atezolizumab
- DRUG Etoposide
- DRUG Tiragolumab
Study Locations (20)
Florida
- Florida Cancer Specialists - Fort Myers
- SCRI Florida Cancer Specialists North - Sarasota
New York
- Broome Oncology - Binghamton - Binghamton
- Memorial Sloan Kettering Cancer Center - New York
Tennessee
- Sarah Cannon Research Institute / Tennessee Oncology - Chattanooga
- Sarah Cannon Research Inst. - Nashville
Virginia
- Virginia Cancer Specialists - Fairfax
- Blue Ridge Cancer Care - Roanoke
New South Wales
- Chris O'Brien Lifehouse - Camperdown
- Nepean Hospital - Kingswood
Colorado
- Rocky Mountain Cancer Centers - Lone Tree - Lone Tree
District of Columbia
- MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center) - Washington D.C.
Georgia
- Northwest Georgia Oncology Centers PC - Marietta - Marietta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2020-02-04 |
| Est. Completion | 2025-07-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04256421
The ClinicalTrials.gov registry entry for NCT04256421 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 490 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 226-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (117% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04256421 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, New York, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04256421 about?
NCT04256421 is a clinical study titled "A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer". This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Coope...
What is the current status of trial NCT04256421?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 490 participants. The study started on 2020-02-04. Estimated completion is 2025-07-31.
What conditions does trial NCT04256421 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer.
What interventions are being tested in trial NCT04256421?
The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Atezolizumab (DRUG), Etoposide (DRUG), Tiragolumab (DRUG).
Who is sponsoring clinical trial NCT04256421?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04256421 being conducted?
This trial has 20 study locations across Colorado, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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