Gefitinib with chemotherapy significantly increased progression-free survival (PFS), and overall survival (OS) compared to gefitinib alone in patients with untreated non-small-cell lung cancer carrying epidermal growth factor receptor mutations in the randomized, open-label, phase III NEJ009 research. For a study, researchers sought to present the most recent data on long-term tolerability and survival outcomes. 

Gefitinib (gefitinib 250 mg orally, once day) and gefitinib combination with carboplatin and pemetrexed (GCP in a 3-week cycle for 6 cycles followed by concurrent gefitinib and pemetrexed maintenance) groups were randomly allocated to patients. GCP substantially outperformed gefitinib in terms of PFS2 at the data cutoff (May 22, 2020) (hazard ratio, 0.77; 95% CI, 0.62 to 0.97; P =.027). The revised median OS for the gefitinib and GCP groups, however, was 38.5 months (95% CI, 31.1 to 47.1) and 49.0 months (95% CI, 41.8 to 56.7), respectively (hazard ratio, 0.82; 95% CI, 0.64 to 1.06; P =.127). 

In terms of the total patient population. Since the first report, no serious adverse events have occurred. The revised research showed that as compared to gefitinib alone, the GCP regimen improved PFS and PFS2 while maintaining a reasonable safety profile. As first-line therapy for non-small-cell lung cancer with mutations in the epidermal growth factor receptor, GCP was more effective than gefitinib monotherapy.