Introduction: Docetaxel plus ramucirumab is a standard second-line treatment for advanced non-small cell lung cancer (NSCLC).Prior immunotherapy has been suggested to potentially affect the efficacy of subsequent docetaxel plus ramucirumab, but prospective evidence is limited.Methods: This multicenter, single-arm, phase II study enrolled patients with advanced NSCLC.Eligible patients had experienced disease progression following a prior immune checkpoint inhibitor (ICI)-containing regimen.Patients received docetaxel 60 mg/m and ramucirumab 10 mg/kg every 3 weeks.The primary endpoint was objective response rate (ORR).Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety.This study was registered in the Japan Registry of Clinical Trials (jRCT1051190091).Results: Between January 8, 2020, and January 7, 2024,We evaluated 33 patients for efficacy and safety.The median age was 69 years, and 26 patients (79%) had an Eastern Cooperative Oncology Group performance status of 1.The ORR was 33.3% (90% confidence interval CI, 19.9-49.1),and the DCR was 90.9% (90% CI, 78.1-97.5).The median PFS and OS were 4.9 months (95% CI, 4.4-6.2) and 11.8 months (95% CI, 9.8-18.8),respectively.No new safety signals were observed.Patients who had responded to prior ICI-containing therapy had longer PFS than those who had not responded (hazard ratio, 0.34; 95% CI, 0.14-0.76).Conclusion: Although the primary endpoint was not met, docetaxel plus ramucirumab demonstrated antitumor activity consistent with previous reports and manageable safety in the post-ICI setting.Efficacy appeared more pronounced in patients with prior response to ICI-containing therapy.
Harutani et al. (Fri,) studied this question.