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ACTIVE NOT RECRUITING
NCT04245514
PHASE2

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

Sponsor: Swiss Cancer Institute

View on ClinicalTrials.gov

Summary

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.

Official title: Immune-modulatory Radiotherapy to Enhance the Effects of Neoadjuvant PD-L1 Blockade After Neoadjuvant Chemotherapy in Patients With Resectable Stage III(N2) Non-small Cell Lung Cancer (NSCLC): A Multicenter Phase II Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2020-07-15

Completion Date

2031-12

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

Durvalumab

Immunotherapy

RADIATION

Radiotherapy

Immune-modulatory radiotherapy to the primary tumor, with either Cohort A: 20 x 2 Gy weekdaily Cohort B: 5 x 5 Gy weekdaily Cohort C: 3 x 8 Gy q2d

Locations (13)

Universitätsklinikum Tübingen

Tübingen, Germany

Kantonsspital Aarau

Aarau, Switzerland

Kantonsspital Baden

Baden, Switzerland

St. Claraspital Basel

Basel, Switzerland

Universitaetsspital Basel

Basel, Switzerland

IOSI Ospedale Regionale di Bellinzona e Valli

Bellinzona, Switzerland

Inselspital

Bern, Switzerland

Kantonsspital Graubuenden

Chur, Switzerland

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Kantonsspital - St. Gallen

Sankt Gallen, Switzerland

Regionalspital Thun

Thun, Switzerland

Stadtspital Triemli

Zurich, Switzerland

Universitätsspital Zuerich

Zurich, Switzerland