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NCT04253964 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
A Phase 2 study of Nonsmall Cell Lung Cancer and Performance Status, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
- 1
- Study location
NCT04253964 is a Phase 2 study of Nonsmall Cell Lung Cancer and Performance Status that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 105 participants, above the 62-participant average among 7 other Nonsmall Cell Lung Cancer trials with a reported enrollment target (69% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04253964, a Phase 2 study of Nonsmall Cell Lung Cancer and Performance Status, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot study is configured as a non-inferiority comparison of Performance Status 2 patients with Performance Status 0-1 patients, with the goal of demonstrating non-inferiority in terms of efficacy (progression-free survival, overall survival) and safety (rates of adverse events, quality of life) when treating Performance Status 2 patients with the same first-line immunotherapy-based regimen as Performance Status 0-1 patients.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Nab paclitaxel
- OTHER Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13)
Study Locations (1)
North Carolina
- Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04253964
The ClinicalTrials.gov registry entry for NCT04253964 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 62-participant average among 7 other Nonsmall Cell Lung Cancer trials with a reported enrollment target (69% higher). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Nonsmall Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04253964 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT04253964 about?
NCT04253964 is a clinical study titled "Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy". This pilot study is configured as a non-inferiority comparison of Performance Status 2 patients with Performance Status 0-1 patients, with the goal of demonstrating non-inferiority in terms of efficacy (progression-free survival, overall survival) and safety (rates of adverse events, quality of life...
What is the current status of trial NCT04253964?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2020-07-01. Estimated completion is 2026-09.
What conditions does trial NCT04253964 study?
This clinical trial studies the following conditions: Nonsmall Cell Lung Cancer, Performance Status.
What interventions are being tested in trial NCT04253964?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Paclitaxel (DRUG), Nab paclitaxel (DRUG), Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13) (OTHER).
Who is sponsoring clinical trial NCT04253964?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04253964 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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