Comparison of survival outcomes between clinical trial participants and non-participants of patients with advanced non-small cell lung cancer: A retrospective cohort study.

Background: Clinical trials for advanced non-small cell lung cancer (NSCLC) have been conducted extensively. However, the effect of participation in clinical trials on survival outcomes remains unclear. This study aimed to assess whether participation in clinical trials was an independent prognostic factor for survival in patients with advanced NSCLC.

Methods: We analyzed the medical records of patients aged ≥18 years who were newly diagnosed with stage IIIB or IV NSCLC and received chemotherapy or immunotherapy from September 2016 to June 2020 in this retrospective cohort study. To reduce the impact of confounding factors, propensity score matching (PSM) was performed. The Kaplan-Meier method and log-rank test were used to calculate and compare the overall survival (OS) and progression-free survival (PFS) of the patients. Finally, Cox proportional hazards regression was employed to examine the correlation between clinical trial participation and survival outcomes.

Results: The study enrolled 155 patients in total, of which 62 (40.0 %) patients participated in NSCLC clinical trials. PSM identified 50 pairs of patients in total. The median PFS and OS of clinical trial participants and non-participants were 17.2 vs. 13.9 months ( = 0.554) and 32.4 vs. 36.5 months ( = 0.968), respectively. According to the results of multivariate Cox proportional hazards regression analysis, clinical trial participation was not an independent prognostic factor for advanced NSCLC patients (: 0.89, 95 % : 0.50-1.61;  = 0.701).

Conclusions: The clinical trial participants with advanced NSCLC displayed similar survival outcomes compared with the non-participating patients in this cohort.