drugset / Trial / NCT05111197

Local Ablative Stereotactic Radiotherapy for Residual Hypermetabolic Lesion in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Long-term Responders to Immunotherapy

NCT05111197

Phase 3 Unknown 112 enrolled Institut Cancerologie de l'Ouest
RandomizedParallel-groupOpen-labelTreatment

Summary

At present, it is recommended to continue immunotherapy until progression or unacceptable toxicity. However, only a minority of patients benefits from a durable response and most see the disease progress despite several months of control under immunotherapy. Multimodal approaches have been developed to improve their prognosis. This study, randomized, open-label study aims to evaluate the impact of addition of ablative radiotherapy on OS of patients with NSCLC and oligometastatic lesions and treated by immunotherapy in first line (potentially associated with chemotherapy) or beyond. Stereotactic radiotherapy will be performed on a maximum of 5 residual hypermetabolic lesions seen on 18F-FDG PET / CT, in patients responding to immunotherapy (or with a stable disease) for at least 6 months.

Timeline

Start
2022-01-12
Primary completion
2025-01
Completion
2025-01

Drugs

EvaluationDrugModalityDoseRoute
Background Atezolizumab Monoclonal antibody
Background Nivolumab Monoclonal antibody
Background Pembrolizumab Monoclonal antibody