Trial SAKK 19/17: First line durvalumab in patients with PD-L1 positve, advanced NSCLC with performance status 2 unsuitable for combination chemotherapy. A multicenter, single-arm phase II trial
Lung cancer is the leading cause of cancer deaths. An estimated 30
to 40% of patients diagnosed with NSCLC have a poor PS defined as a
score of 2 or higher on the ECOG scale. PS 2 patients are often
underrepresented in clinical trials despite representing a very
frequent and important subgroup.
Platinum-based (preferably carboplatin) doublets should be considered as standard of care in eligible PS 2 pa-tients. However the toxicity profile of platinum-based doublets remains a concern. Single-agent chemotherapy represents an alternative treatment option for the PS 2 patients considered unsuitable for platinum doublet chemotherapy but its efficacy is limited and the outcome poor.
Given the superiority of the anti-PD-1 antibody pembroli-zumab versus standard chemotherapy as first line thera-py in a PD-L1 positive NSCLC population, it now became the standard treatment. The PS of patients enrolled in these trials were PS 0 or 1, making the benefit of PD-L1 antibodies in PS 2 patients unclear. A retrospective real-life data analysis of nivolumab in metastatic NSCLC re-vealed similar treatment-related AE between patients with a PS of 0 or 1 with those having a PS of 2, confirming good treatment tolerability in poor PS patients.
The overall favorable toxicity profile of durvalumab and the absence of robust efficacy data of checkpoint inhibi-tors in first line treatment of patients with PD-L1 positive NSCLC with a PS of 2, encourage to investigate its activ-ity in this cohort of patients when considered unsuitable for platinum doublet chemotherapy.
Finally, this trial aims to prolong overall survival by treating this cohort of frail patients with durvalumab, compared to historical controls, treated with single agent chemotherapy while providing a better tolerability profile.
|type of project||clinical studies|
|status||ongoing - recruiting phase|
|start of project||2018|
|end of project||2021|
|study design||Offene einarmige Phase II Studie|
|responsible person||PD Dr. Martin Früh|