Multinational phase 3 trial of plinabulin plus docetaxel for EGFR wild-type NSCLC after progression on platinum-based regimen

There is an unmet need for second-line and third-line treatments for locally advanced or metastatic non-small cell lung cancer (NSCLC) without driver mutations. The phase 3 DUBLIN-3 trial, at 58 centers in Australia, China and the United Stated randomized patients with advanced EGFR wild-type NSCLC after progression on first-line platinum-based therapy 1:1 to docetaxel plus either plinabulin or placebo until progression, unacceptable toxicity, withdrawal, or death. Primary endpoint was overall survival. Median OS was 10.5 months in the plinabulin group versus 9.4 months in the placebo group (sHR 0.82; p=0.0399).Treatment-emergent adverse events occurred in >99% of patients in the plinabulin group and 99% of the placebo group. Grade 3 or 4 gastrointestinal disorders occurred more frequently in the plinabulin group than in the placebo group, the most frequent being diarrhea (9% versus 1%) and vomiting (2% versus <1%), as did transient grade 3 hypertension (18% versus 3%). Treatment-emergent death was reported for 4% in both groups. The authors conclude that plinabulin plus docetaxel significantly improved OS as second-line and third-line treatment in patients with advanced or metastatic EGFR wild-type NSCLC.