- The HIV protease inhibitor nelfinavir mesylate in combination with chemoradiotherapy (CRT) offered promising local control, OS, and response rates in a phase 1/2 trial of inoperable, locally advanced NSCLC.
Why this matters
- The 2-year local failure rate in this study was better than the rates reported in the stage IIIA-IIIB NSCLC benchmark RTOG 0617 trial.
- 35 patients with locally advanced NSCLC received concurrent CRT with nelfinavir 625 mg (DL1; n=5) or 1250 mg (DL2; n=30) orally twice daily.
- Median follow-up was 6.8 years.
- Funding: NIH; others.
- Grade 3-4 AEs were similar between groups and included leukopenia, esophagitis, and pneumonitis.
- Local failure rate was 39% overall, based on all 35 patients.
- Rate was 26% at 2 years and 34% at 4 years.
- Distant failure rate was 60% overall, based on all patients.
- Rate was 46% at 1 year and 54% at 2 years.
- Median PFS, 11.7 months.
- Median OS, 41.1 months.
- Mean OS was 57.1% at 2 years, 51.4% at 3 years, and 37.1% at 5 years.
- Partial response rate was 94%; stable disease response rate was 6%.
- Early-phase, single-group, monocentric study.