Trials / Completed
CompletedNCT04774380
Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer
A Phase IIIb, Single-arm, Multi-center, International Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer (LUMINANCE)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 152 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
Summary
Study to determine the safety and tolerability profile of durvalumab with platinum (cisplatin or carboplatin) plus etoposide (EP) as first-line treatment in participants with extensive-stage small-cell lung cancer.
Detailed description
The study will be conducted in North America, Europe and Turkey. In this single arm study participants will be treated with with durvalumab alone and concurrently with platinum-based chemotherapy and etoposide during the study period until radiological disease progression, unless there is clinical progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met, as per investigator assessment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalumab | Participants will receive durvalumab via IV infusion on Day 1 of each cycle. |
| DRUG | Cisplatin | Participants will receive cisplatin via IV administration on Day 1 of each cycle. |
| DRUG | Carboplatin | Participants will receive carboplatin via IV administration Day 1 of each cycle. |
| DRUG | Etoposide | Participants will receive etoposide via IV administration on days 1 to 3 of each cycle. |
Timeline
- Start date
- 2021-11-11
- Primary completion
- 2023-06-12
- Completion
- 2025-01-02
- First posted
- 2021-03-01
- Last updated
- 2025-05-23
- Results posted
- 2024-08-20
Locations
35 sites across 6 countries: Bulgaria, Canada, Czechia, Germany, Italy, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04774380. Inclusion in this directory is not an endorsement.