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NCT02763579 · ClinicalTrials.gov registry record · Phase 3
A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 503
- Enrollment target
NCT02763579 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 503 participants.
The verdict
NCT02763579, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 503 participants
- Enrollment target
Study Summary
This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
Interventions
- DRUG Carboplatin
- DRUG Placebo
- DRUG Etoposide
- DRUG Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 503 participants |
| Start Date | 2016-06-07 |
| Est. Completion | 2022-07-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02763579
The ClinicalTrials.gov registry entry for NCT02763579 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 503 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT02763579 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02763579 about?
NCT02763579 is a clinical study titled "A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)". This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplat...
What is the current status of trial NCT02763579?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 503 participants. The study started on 2016-06-07. Estimated completion is 2022-07-07.
What interventions are being tested in trial NCT02763579?
The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Etoposide (DRUG), Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody (DRUG).
Who is sponsoring clinical trial NCT02763579?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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