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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: Completed Phase 3 study of Small-cell Lung Cancer, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
PFS was defined as the time from randomization to the first documented PD as determined by the investigator with the use of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase
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 |
What the finished NCT04256421 record still lists
NCT04256421 is an interventional study that assigns participants to a tested intervention. The registered 490 participants enrollment target is mid-sized for trials with a published cap, above the 226-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (117% higher).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
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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 NCT04256421's enrollment target sits among peer trials
490 12th of 79 higher than 68 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.
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