Multimodality Treatment in Stage III Non-small Cell Lung Cancer (NSCLC)

Resectable, locally advanced NSCLC with involvement of mediastinal lymph nodes (N2) is associated with a high risk of (systemic) recurrence despite neo-adjuvant chemotherapy. Neo-adjuvant immunotherapy is a promising additional treatment modality aiming at increasing local control and better tackling micrometastases at the time of radical local treatment. Radiotherapy is thought to act synergistically with immunotherapy through release of tumor antigens and modulation of the local immune microenvironment in favor of a better antigen-presentation and (systemic) anti-tumor immune response (abscopal effect). The aim of the proposed SAKK 16/18 trial is to evaluate the efficacy and safety of adding immune-modulatory radiotherapy to the SAKK 16/14 treatment regimen by combining neo-adjuvant radio-immunotherapy. Due to the lack of evidence for an optimal radiotherapy regimen for an "in-situ vaccination" effect three different radiotherapy regimens will be tested.

NCT Number	NCT04245514
Lead Sponsor	Swiss Cancer Institute
Conditions	Non-small Cell Lung Cancer, NSCLC
Enrollment	90 participants
Start Date	2020-07-15
Primary Completion	2026-07-16 (estimated)
Study Completion	2031-12 (estimated)
Updated on ClinicalTrials.gov	2026-04-02