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Cemiplimab-Rwlc / Nonsmall Cell Lung Cancer / Performance Status · Phase 2 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry record for an ongoing Phase 2 pilot study comparing immunotherapy-based chemotherapy outcomes in Performance Status 2 versus Performance Status 0–1 non-small cell lung cancer patients. No results are posted in this registry entry; the study is still recruiting and no efficacy or safety data are available for evidence appraisal.
Phase 2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Nonsmall Cell Lung Cancer, Performance Status; age from 18 Years. Intervention: Performance Status 0-1 Participants; Performance Status 2 Participants. Compared with: Same first-line immunotherapy-based chemotherapy regimen in Performance Status 0–1 patients.. n = 105. 1 site: United States.
This is a clinical trial registry record for an ongoing Phase 2 pilot study comparing immunotherapy-based chemotherapy outcomes in Performance Status 2 versus Performance Status 0–1 non-small cell lung cancer patients. No results are posted in this registry entry; the study is still recruiting and no efficacy or safety data are available for evidence appraisal.
Primary endpoint is progression-free survival at 12 weeks only; longer-term efficacy and safety outcomes are not described in the registry text.
When results become available, this pilot study may inform whether Performance Status 2 patients tolerate and benefit from intensive immunotherapy-chemotherapy regimens as well as better-performance patients, potentially expanding treatment eligibility. Until data are reported, no clinical action should be taken based on this registration.
This is a Phase 2 pilot study registration with no reported results; it is designed to compare outcomes between performance status groups but enrollment and follow-up are ongoing.
As stated by the source record.
Quoted from the source exactly as published.
When results become available, this pilot study may inform whether Performance Status 2 patients tolerate and benefit from intensive immunotherapy-chemotherapy regimens as well as better-performance patients, potentially expanding treatment eligibility. Until data are reported, no clinical action should be taken based on this registration.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04253964). This is a study registration, not published results. Lead sponsor: Wake Forest University Health Sciences. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 105 participants (ESTIMATED). Conditions: Nonsmall Cell Lung Cancer, Performance Status. Interventions: DRUG: Pembrolizumab; DRUG: Atezolizumab; DRUG: Cemiplimab-Rwlc; DRUG: Carboplatin; DRUG: Paclitaxel; DRUG: Nab paclitaxel; DRUG: Pemetrexed; DRUG: Cisplatin; OTHER: 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). Primary outcome measures: Proportion of Participants with Progression-Free Survival , From baseline to end of 4th cycle of treatment (12 weeks). Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.