KEY TAKEAWAYS
- The ALTER-L024 phase 2 trial aimed to evaluate the safety and effectiveness of anlotinib combined with docetaxel as a 2L treatment for advanced NSCLC patients.
- The primary endpoint was to determine PFS.
- The combination of anlotinib and docetaxel was found to be a viable therapeutic option for NSCLC patients who had not responded to platinum-based treatment.
As second-line (2L) therapy for patients with advanced non-small cell lung cancer (NSCLC), Xingxiang Pu and the team sought to assess the safety and therapeutic potential of combining anlotinib with docetaxel vs docetaxel alone. This was due to the limited effectiveness of docetaxel in this setting.
In a phase II trial, NSCLC patients who had not responded to first-line (1L) platinum-based regimens were randomized 1:1. Either docetaxel alone or in combination with anlotinib was administered to them. Progressiveness-free survival (PFS) was the primary endpoint, whereas overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety were the secondary endpoints.
Of 83 randomized patients, the combination therapy of anlotinib and docetaxel significantly prolonged median PFS to 4.4 months (HR=0.38, 95% CI: 0.23–0.63, P=0.0002) compared to 1.6 months with docetaxel alone. Furthermore, it exhibited superior ORR (32.5% vs. 9.3%, P=0.0089) and DCR (87.5% vs. 53.5%, P=0.0007). Median OS was 12.0 months in the combination group versus 10.9 months in monotherapy (HR=0.82, 95% CI: 0.47–1.43, P=0.4803). Patients previously treated with immunotherapy had notably longer median PFS at 7.8 versus 1.7 months (HR=0.22, 95% CI: 0.09–0.51, P=0.0290).
Incidence of grade ≥3 treatment-related adverse events (TRAEs), mainly leukopenia (15.0% vs. 7.0%) and neutropenia (10.0% vs. 5.0%), was manageable across both groups.
The study found that combined treatment of anlotinib and docetaxel is effective for advanced NSCLC patients who have not responded to initial platinum-based therapies.
The trial was sponsored by China Medical University, China.
Source: https://www.lungcancerjournal.info/article/S0169-5002(24)00071-0/abstract#%20
Clinical Trial: https://clinicaltrials.gov/study/NCT03732001
Pu X, Xiao Z, Li J, et al. (2024) “Anlotinib plus docetaxel vs. docetaxel alone for advanced non-small-cell lung cancer patients who failed first-line treatment: A multicenter, randomized phase II trial.” DOI: https://doi.org/10.1016/j.lungcan.2024.107538.
