Results from the J-SONIC trial comparing nintedanib plus chemotherapy with chemotherapy alone for lung cancer with concomitant IPF have been reported. Although there was no significant difference in the primary endpoint of IPF progression-free survival, overall survival showed a trend toward improvement in nonsquamous cancer. Some adverse events were more common in the combination group because of side effects.
The J-SONIC trial randomly compared nintedanib plus chemotherapy with chemotherapy alone in patients with advanced NSCLC and concomitant idiopathic pulmonary fibrosis (IPF). The trial enrolled 243 patients at 72 sites in Japan, assigning 121 to the combination group and 122 to the chemotherapy-alone group. The primary endpoint was IPF-PFS.
Median IPF-PFS, the primary endpoint, was 14.6 months in the combination group and 11.8 months in the chemotherapy-alone group. The hazard ratio was 0.89 (90% CI 0.67–1.17, p=0.24), which did not reach statistical significance. Meanwhile, the overall response rate, a secondary endpoint, was 69% in the combination group and 56% in the chemotherapy-alone group, a significant difference (p=0.04).
Median progression-free survival (PFS) was 6.2 months in the combination group and 5.5 months in the chemotherapy-alone group, with an HR of 0.68 (95% CI 0.50–0.92), indicating an improvement. Overall survival (OS) in nonsquamous cancer was 16.1 months in the combination group and 13.1 months in the chemotherapy-alone group, with an HR of 0.61 (95% CI 0.40–0.93). Combination treatment increased febrile neutropenia, diarrhea and proteinuria, but there was no difference in overall QoL.
Although the trial did not meet its primary endpoint, the findings suggest that nintedanib plus chemotherapy may be a treatment option for advanced NSCLC with concomitant IPF, particularly nonsquamous cancer.