2024 World Conference on Lung Cancer (WCLC) - Posters-P4.11D.011 Evaluating the Impact of Performance Status on Outcomes in Advanced Lung Cancer: A Phase II Clinical Trial

P4.11D.011 Evaluating the Impact of Performance Status on Outcomes in Advanced Lung Cancer: A Phase II Clinical Trial

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The document outlines a Phase II clinical trial evaluating the outcomes of treating advanced non-small cell lung cancer (NSCLC) patients, particularly those with borderline performance status (ECOG PS 2), using immunotherapy-based regimens. NSCLC is the leading cause of cancer-related deaths in the United States, with most cases lacking actionable genetic alterations and commonly treated with immunotherapy, with or without chemotherapy. Current treatment guidelines mostly cater to patients with better performance status (ECOG PS 0-1), while about 20-40% of patients have a borderline status (ECOG PS 2), which complicates treatment due to potential chemotherapy toxicity and inter-rater variability in performance status assessment.<br /><br />The trial aims to provide valuable clinical data to assess the non-inferiority of standard first-line treatments among advanced NSCLC patients with an ECOG PS of 2. It involves 105 treatment-naïve patients assigned to typical first-line regimens based on PD-L1 status and professional guidelines, including pembrolizumab alone or in combination with carboplatin and pemetrexed for non-squamous cancer, or carboplatin with paclitaxel for squamous cancer. The study's primary outcome is progression-free survival after three months, alongside secondary and exploratory outcomes such as adverse events, quality of life changes, and overall response rates.<br /><br />Additionally, the trial seeks to generate hypothesis-driven data on lymphocyte metabolomics, comorbidities, and the reliability of performance status assessments. The study is pragmatic in design, enhancing its external validity and applicability to clinical practice. Completion of the trial is anticipated by 2025, potentially influencing future treatment protocols for patients with borderline performance status.

Asset Subtitle

Martin Porebski

Meta Tag

Speaker Martin Porebski

Topic Metastatic NSCLC – Immunotherapy

Keywords

Phase II clinical trial

non-small cell lung cancer

NSCLC

immunotherapy

ECOG PS 2

performance status

progression-free survival

pembrolizumab

carboplatin

lymphocyte metabolomics