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NCT04581824 · ClinicalTrials.gov registry record · Phase 2
Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 243
- Enrollment target
NCT04581824: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.
NCT04581824 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 243 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04581824, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 243 participants
- Enrollment target
Study Summary
NSCLC comprises of approximately 84 percent (%) of all lung cancers and is often diagnosed at advanced stage due to poor prognosis. Dostarlimab is an immunoglobulin G (IgG)4 kappa humanized monoclonal antibody (mAb) that binds with high affinity to programmed cell death protein 1 (PD 1), resulting in inhibition of binding to programmed death ligand 1 (PD L1) and programmed death ligand 2 (PD L2). This study aims to compare the efficacy and safety PD-1 inhibitors dostarlimab and pembrolizumab, when administered in combination with chemotherapy (pemetrexed, cisplatin and carboplatin), in participants with non-squamous NSCLC without a known sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or receptor tyrosine kinase-1 (ROS-1) mutation, BRAF V600E mutation, or other genomic aberration for which an approved targeted therapy is available. A total of approximately 240 participants will be enrolled in the study for a period of 5 years.
Primary Outcome
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or confirmed partial response (PR) as their best overall response (BOR) recorded from the date of randomization until disease progression or initiation of new anti-cancer therapy, whichever is earlier based on blinded independent central review (BICR) evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must b
Interventions
- DRUG Pembrolizumab
- DRUG Chemotherapy
- DRUG Dostarlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2024-09-10 |
| Phase | Phase 2 |
Why NCT04581824 stopped before completion
NCT04581824 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% higher).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04581824 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04581824 about?
NCT04581824 is a clinical study titled "Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)". NSCLC comprises of approximately 84 percent (%) of all lung cancers and is often diagnosed at advanced stage due to poor prognosis. Dostarlimab is an immunoglobulin G (IgG)4 kappa humanized monoclonal antibody (mAb) that binds with high affinity to programmed cell death protein 1 (PD 1), resulting i...
What is the current status of trial NCT04581824?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 243 participants. The study started on 2020-11-19. Estimated completion is 2024-09-10.
What interventions are being tested in trial NCT04581824?
The interventions under investigation include: Pembrolizumab (DRUG), Chemotherapy (DRUG), Dostarlimab (DRUG).
Who is sponsoring clinical trial NCT04581824?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04581824's enrollment target sits among peer trials
243 236th of 2000 higher than 1,764 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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