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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 Non-Small 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: Recruiting Phase 2 study of Non-Small Cell Lung Cancer and Performance Status, sponsored by Wake Forest University Health Sciences.
NCT04253964 is a Phase 2 study of Non-Small 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, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04253964, a Phase 2 study of Non-Small 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.
Primary Outcome
Using non-blinded central imaging using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 to define progressive disease. RECIST v 1.1 criteria: * Complete Response (CR): Disappearance of all target lesions. * Partial Response (PR): Decrease by ≥ 30% in sum of longest diameter of target lesions. * Stable Disease (SD): Not meeting criteria for CR, PR, or PD. * Progressive Disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more
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 |
What NCT04253964 shows while recruiting
NCT04253964 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04253964 reports a single indexed study location in 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: Non-Small 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.
Learn More About Clinical Trials
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Where NCT04253964's enrollment target sits among peer trials
105 228th of 454 higher than 227 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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