Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
Public ClinicalTrials.gov record NCT04253964. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase II Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-Small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04253964
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 105 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Drug
- Atezolizumab Drug
- Cemiplimab-Rwlc Drug
- Carboplatin Drug
- Paclitaxel Drug
- Nab paclitaxel Drug
- Pemetrexed Drug
- Cisplatin Drug
- Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13) Other
- QLQ-C30 Global Health/Quality of Life Questionnaire Other
- COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes Other
- PROMIS and FACT-G Questionnaires Other
- Sleep Disorder Assessments (ISI, Berlin Sleep Questionnaire) Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 1, 2020 (Actual)
- Primary completion
- Sep 1, 2027 (Estimated)
- Completion
- Sep 1, 2027 (Estimated)
- Last update posted
- Sep 25, 2026
2020 – 2027
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | Recruiting |
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04253964, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 25, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04253964 live on ClinicalTrials.gov.