drugset / Trial / NCT03542461
Early Switch Maintenance vs Delayed Second-line Nivolumab in Advanced Stage Squamous Non-small Cell Lung Cancer (NSCLC) Patients (EDEN Trial)
Phase 3
Unknown
125 enrolled
Italian Oncology Group for Clinical Research
Bioikos Ambiente Srl · collabBristol Myers Squibb Srl Italia · collabIstituto Toscano Tumori · collabMipharm S.p.A. · collabTemas srl · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The study's hypothesis is that using Nivolumab as early switch maintenance, after 4-6 cycles of standard first-line chemotherapy, might improve survival in patients with advanced stage squamous NSCLC.
Timeline
- Start
- 2017-09-25
- Primary completion
- 2023-01-31
- Completion
- 2023-01-31
Outcome
Missed primary endpoint
paper mOS (95 % CI) was 14.9 (10.4-18.6) months in arm A vs 18.8 (14.4-21.1) months in arm B (HR 1.09, 95 %CI 0.74-1.62, p = 0.659). PMID 39700681 ↗
paper CONCLUSIONS: In advanced Sq-NSCLC, the use of Nivo as switch maintenance after 1st-line CHT, does not improve OS compared to its use as 2nd-line. PMID 39700681 ↗
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |