Trials / Terminated
TerminatedNCT03430063
A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer
A Randomized, Open-Label Study of Combinations of Standard and High Dose REGN2810 (Cemiplimab; Anti-PD-1 Antibody) and Ipilimumab (Anti-CTLA-4 Antibody) in the Second-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Regeneron Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in \<50% of tumor cells.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SDREGN2810 | Standard dose intravenous (IV) infusion |
| DRUG | SDREGN2810/ipi | Combination therapy dose IV |
| DRUG | HDREGN2810 | High dose IV |
Timeline
- Start date
- 2018-05-29
- Primary completion
- 2021-10-27
- Completion
- 2021-10-27
- First posted
- 2018-02-12
- Last updated
- 2022-11-03
- Results posted
- 2022-11-03
Locations
31 sites across 9 countries: United States, Belgium, France, Germany, Poland, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03430063. Inclusion in this directory is not an endorsement.