A single-centre retrospective observational study of 90 patients from Australia with extensive-stage small cell lung cancer (SCLC) shows that phase I clinical trial participation has acceptable safety and survival outcomes comparable to those of standard-of-care (SoC) treatment.
The study included 76 patients treated with SoC and 14 patients who participated in phase I clinical trials in 2013–2024. The median number of prior lines of treatment was significantly greater among patients enrolled in phase I trials vs those who received SoC (3 vs 1; p=0.001). Grade 2 adverse events (AEs) were significantly more prevalent among phase I group (50.00 vs 19.74 percent; p=0.036). However, grade ≥3 AEs were similar between the two groups. [Gutierrez FL, et al, ESMO TAT Asia 2026, poster]
The objective response rate was numerically lower in the phase I vs SoC group (21.43 vs 38.16 percent), but the difference did not reach statistical significance. The authors highlighted that disease stabilization was more frequent among phase I participants.
While progression-free survival was similar between the two groups, a significantly longer median overall survival was reported in the phase I vs SoC group (16.5 vs 11.0 months; p=0.023). The authors noted that prior lines of therapy were not associated with survival outcomes in the phase I cohort.
“These findings support the feasibility of early-phase trial enrolment in SCLC and highlight the need for improved patient selection and biomarker-driven strategies to optimize benefit,” they concluded.