RecruitingPhase 2NCT04253964

Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

Phase II Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-Small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy


Sponsor

Wake Forest University Health Sciences

Enrollment

105 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing how well chemotherapy combined with immunotherapy works in non-small cell lung cancer patients who are in poor general health (performance status 2, meaning limited in activity) versus those who are in good health (performance status 0–1), to see if sicker patients can still benefit from these treatments. **You may be eligible if:** - You are at least 18 years old - You have non-small cell lung cancer that has spread or cannot be surgically removed - You have not had prior chemotherapy or immunotherapy for advanced disease - Your life expectancy is more than 3 months - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if:** - You have already received chemotherapy or immunotherapy for non-curable disease - You are pregnant or not using effective contraception - Your blood counts or organ function are too low to safely receive treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

ALL PARTICIPANTS: Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle for 4 cycles. Participants with predictive biomarker PD-L1 greater than or equal to 50% will not receive any other drugs besides pembrolizumab.

DRUGCarboplatin

FOR PARTICIPANTS IN EITHER ARM with non-squamous OR squamous subtype, predictive biomarker PD-L1 less than 50%: Carboplatin area under the curve (AUC) 5 IV on day 1 of each 3-week cycle for 4 cycles.

DRUGPaclitaxel

FOR PARTICIPANTS IN EITHER ARM with squamous subtype, predictive biomarker PD-L1 less than 50%: Paclitaxel 200 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.

DRUGNab paclitaxel

FOR PARTICIPANTS IN EITHER ARM with squamous subtype, predictive biomarker PD-L1 less than 50%: Nab-paclitaxel 100 mg/m2 on day 1, 8, 15 of 3-week cycle for 4 cycles.

OTHERQuality of Life Questionnaire, lung cancer-specific (QLQ-LC13)

The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.

OTHERQLQ-C30 Global Health/Quality of Life Questionnaire

30 item questionnaire - Functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures

OTHERCOPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes

Dyspnea scale scores in patients with respiratory disease (particularly COPD) to establish baseline functional dyspnea burden (taken pre-study at Week 0 and Post Treatment at week 13)

DRUGPemetrexed

FOR PARTICIPANTS IN EITHER ARM with nonsquamous subtype, predictive biomarker PD-L1 less than 50%: Pemetrexed 500 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.


Locations(1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

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NCT04253964


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