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NCT03064854 · ClinicalTrials.gov registry record · Phase 1
PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 111
- Enrollment target
NCT03064854: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT03064854 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 111 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03064854, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 111 participants
- Enrollment target
Study Summary
The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of PDR001 when administered in combination with platinum-doublet chemotherapy and other immunooncology agent(s) in treatment naive patients with PD-L1 unselected, advanced NSCLC, and to estimate the preliminary anti-tumor activity in this patient population.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 42 days
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Gemcitabine
- DRUG PDR001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2017-05-24 |
| Est. Completion | 2021-07-28 |
| Phase | Phase 1 |
Why NCT03064854 stopped before completion
NCT03064854 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% higher).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT03064854 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03064854 about?
NCT03064854 is a clinical study titled "PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients". The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of PDR001 when administered in combination with platinum-doublet chemotherapy and other immunooncology agent(s) in treatment naive patients with PD-L1 unselected, advanced N...
What is the current status of trial NCT03064854?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 111 participants. The study started on 2017-05-24. Estimated completion is 2021-07-28.
What interventions are being tested in trial NCT03064854?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Gemcitabine (DRUG), PDR001 (DRUG).
Who is sponsoring clinical trial NCT03064854?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03064854's enrollment target sits among peer trials
111 512th of 2000 higher than 1,487 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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