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NCT04863248 · ClinicalTrials.gov registry record · Phase 2
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRESERVE 4)
A Phase 2 study, sponsored by G1 Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT04863248: Clinical Trial Phase 2 study, sponsored by G1 Therapeutics.
NCT04863248 is a Phase 2 study that was terminated before completion, run by G1 Therapeutics. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04863248, a Phase 2 study, was terminated before completion, sponsored by G1 Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 trial evaluating the effect of trilaciclib on overall survival when administered prior to docetaxel in patients with metastatic NSCLC treated in the 2nd or 3rd line setting.
Primary Outcome
To assess the effects of trilaciclib administered prior to docetaxel compared with placebo administered prior to docetaxel on occurrence and severity of adverse events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, study treatment discontinuation due to adverse events (AEs), and trilaciclib adverse events of special interest (AESI) in patients with metastatic NSCLC receiving docetaxel in the second or third line.
Interventions
- DRUG Placebo
- DRUG Docetaxel
- DRUG Trilaciclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-04-30 |
| Est. Completion | 2022-02-02 |
| Phase | Phase 2 |
Why NCT04863248 stopped before completion
NCT04863248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04863248 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04863248 about?
NCT04863248 is a clinical study titled "Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRESERVE 4)". This is a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 trial evaluating the effect of trilaciclib on overall survival when administered prior to docetaxel in patients with metastatic NSCLC treated in the 2nd or 3rd line setting.
What is the current status of trial NCT04863248?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2021-04-30. Estimated completion is 2022-02-02.
What interventions are being tested in trial NCT04863248?
The interventions under investigation include: Placebo (DRUG), Docetaxel (DRUG), Trilaciclib (DRUG).
Who is sponsoring clinical trial NCT04863248?
This trial is sponsored by G1 Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04863248's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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