Phase III randomised controlled trial comparing maintenance with the addition of local ablative treatment for patients with advanced stage IV non-small cell lung cancer (salVage-Trial) – with SNSF funding for an IICT

Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death worldwide. Up to 70% of all NSCLC patients present with already metastasized stage IV and are treated with systemic therapy alone as the current standard of care (SoC). Despite improvement of systemic therapy with excellent response rates, the median progression free survival (PFS) ranges between 5 to 25 months. To date, there are no recommendations about additional treatments for residual disease in patients responding to initial systemic therapy. Such approaches, named “local ablative therapy” (LAT), comprise surgical resection and/or radiotherapy to all residual lesions. Several retrospective cohort studies have documented promising outcome of so-called “salvage surgery” in these situations with median overall survival (OS) of 9 to 75 months, 5-year survival rates of 20-75% and increased PFS ranging between 5 and 43 months.

Rationale and aim: We hypothesize that LAT of NSCLC patients upon response to initial systemic treatment to an oligopersistent diease state will lead to an improvement of patients’ PFS with at least maintained QoL at six months from randomization.

Methodology: To confirm our hypothesis, a multicentre prospective RCT will be performed to assess two co-primary endpoints: PFS calculated from randomization and QoL measured with patient-reported outcome measures (PROMs) at six months from randomization using the EQ-5D-5L score with a hierarchical ordering.