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NCT03430063 · ClinicalTrials.gov registry record · Phase 2
A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT03430063: Clinical Trial Phase 2 study, sponsored by Regeneron Pharmaceuticals.
NCT03430063 is a Phase 2 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03430063, a Phase 2 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study 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.
Primary Outcome
ORR was defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of participants in the efficacy analysis set. BOR was defined as the best response recorded, as determined by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) between the date of randomization and the date of the first objectively documented progression or the date of su
Interventions
- DRUG SDREGN2810
- DRUG SDREGN2810/ipi
- DRUG HDREGN2810
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2018-05-29 |
| Est. Completion | 2021-10-27 |
| Phase | Phase 2 |
Why NCT03430063 stopped before completion
NCT03430063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 3 interventions - of which SDREGN2810 is the first listed.
NCT03430063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03430063 about?
NCT03430063 is a clinical study titled "A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer". 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 ...
What is the current status of trial NCT03430063?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2018-05-29. Estimated completion is 2021-10-27.
What interventions are being tested in trial NCT03430063?
The interventions under investigation include: SDREGN2810 (DRUG), SDREGN2810/ipi (DRUG), HDREGN2810 (DRUG).
Who is sponsoring clinical trial NCT03430063?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03430063's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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