Trials / Completed
CompletedNCT02395172
Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)
A Phase III Open-Label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer That Has Progressed After a Platinum-Containing Doublet
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 792 (actual)
- Sponsor
- EMD Serono Research & Development Institute, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avelumab | Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
| DRUG | Docetaxel | Participants received 75 mg per square meter (m\^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled. |
Timeline
- Start date
- 2015-03-24
- Primary completion
- 2017-11-22
- Completion
- 2019-12-03
- First posted
- 2015-03-20
- Last updated
- 2020-08-03
- Results posted
- 2018-12-13
Locations
260 sites across 29 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Czechia, Denmark, France, Hungary, Israel, Italy, Japan, Mexico, Peru, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02395172. Inclusion in this directory is not an endorsement.