Clinical lung cancer · 2026
ENTRÉE Lung Platform Trial Sub-study 1: Phase II Randomized Efficacy and Safety Analysis of Feladilimab Plus Docetaxel Versus Docetaxel Monotherapy in Advanced/Recurrent NSCLC.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Garassino Marina Chiara, Cousin Sophie, Besse Benjamin, Sacher Adrian, Orlov Sergey, Schenker Michael, Felip Enriqueta, Gladkov Oleg, Messina Cristina H, Majumdar Antara, Wu Zhenhua Jeremy, Karpinich Natalie O, Hirschfeld Steven, Ballas Marc, Reck Martin
Аннотация
BACKGROUND: Combining treatments with different mechanisms may improve immunosurveillance and outcomes in advanced/recurrent non-small cell lung cancer (NSCLC) after immunotherapy. ENTRÉE Lung (NCT03739710) is a phase 2, open-label platform trial utilizing a master protocol to investigate novel regimens versus standard of care (SoC) in separate sub-studies. Sub-study 1 investigated the immunoglobulin G4 inducible T-cell costimulator agonist antibody, feladilimab, plus docetaxel versus SoC, docetaxel monotherapy.
PATIENTS AND METHODS: Patients with advanced/recurrent NSCLC who progressed on prior anti-programmed cell death (ligand)-1 and platinum-based combination chemotherapies were randomized to feladilimab (80 mg) plus docetaxel 75 mg/m2 (both intravenous) or docetaxel 75 mg/m2 every 3 weeks until progressive disease/unacceptable toxicity. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), tumor response (including overall response rate [ORR]), and safety. Exploratory endpoints included biomarkers.
RESULTS: A total of 105 patients were randomized to feladilimab plus docetaxel (n = 70) or docetaxel (n = 35). Median OS was 7.8 months with feladilimab plus docetaxel versus 8.2 months with docetaxel; hazard ratio (HR) 1.5 (95% confidence interval [CI], 0.92, 2.44). Median PFS for feladilimab plus docetaxel versus docetaxel was 3.4 months versus 3.3 months, and ORR was 19% versus 11%; HR 0.84 (95% CI, 0.54, 1.32). Most frequently reported treatment-related adverse events included anemia (34% vs. 24%), nausea (34% vs. 15%), alopecia (27% vs. 21%), and asthenia (27% vs. 18%).
CONCLUSION: Feladilimab plus docetaxel has an acceptable safety profile in the second-line treatment of advanced/recurrent NSCLC. No survival outcomes or tumor response advantages were observed with the addition of feladilimab to docetaxel in this setting.
PATIENTS AND METHODS: Patients with advanced/recurrent NSCLC who progressed on prior anti-programmed cell death (ligand)-1 and platinum-based combination chemotherapies were randomized to feladilimab (80 mg) plus docetaxel 75 mg/m2 (both intravenous) or docetaxel 75 mg/m2 every 3 weeks until progressive disease/unacceptable toxicity. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), tumor response (including overall response rate [ORR]), and safety. Exploratory endpoints included biomarkers.
RESULTS: A total of 105 patients were randomized to feladilimab plus docetaxel (n = 70) or docetaxel (n = 35). Median OS was 7.8 months with feladilimab plus docetaxel versus 8.2 months with docetaxel; hazard ratio (HR) 1.5 (95% confidence interval [CI], 0.92, 2.44). Median PFS for feladilimab plus docetaxel versus docetaxel was 3.4 months versus 3.3 months, and ORR was 19% versus 11%; HR 0.84 (95% CI, 0.54, 1.32). Most frequently reported treatment-related adverse events included anemia (34% vs. 24%), nausea (34% vs. 15%), alopecia (27% vs. 21%), and asthenia (27% vs. 18%).
CONCLUSION: Feladilimab plus docetaxel has an acceptable safety profile in the second-line treatment of advanced/recurrent NSCLC. No survival outcomes or tumor response advantages were observed with the addition of feladilimab to docetaxel in this setting.