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Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study — ROSE  

NSCLC Clinical Trial

Official title:
Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study

Clinical Trial Summary

Study Objectives are: To assess the safety of osimertinib treatment continuation during irradiation therapy for palliation or oligoprogressive disease by assessment of grade 3-5 AEs during and after concomitant osimertinib and irradiation of tumor sites. To assess the efficacy of osimertinib treatment continuation during irradiation therapy for palliation or oligoprogressive disease. To investigate Quality of Life during and after irradiation therapy and concomitant osimertinib.

Clinical Trial Description

Many patients with advanced lung cancer require palliative irradiation of metastases to relieve symptoms and prevent local complications. In addition, guidelines recommend local treatment (including radiation) for oligoprogression during TKI treatment. Clinicians are faced with the decision whether to continue TKI therapy during irradiation, a practice for which there is little data, or to interrupt the oral treatment for the duration of radiation, which may lead to progression of non-irradiated lesions. For erlotinib and gefitinib there is some data indicating that cranial irradiation as well as stereotactic body irradiation may be carried out safely without discontinuing or interrupting the TKI treatment. Although some small case series report on a PFS benefit with irradiation during osimertinib treatment, there is very limited data on the safety of osimertinib during irradiation, and no evidence-based recommendations around stopping osimertinib for irradiation. The hypothesis is that osimertinib can be continued without interruption during irradiation of individual tumor lesions in the setting of oligoprogressive NSCLC, or for local symptom control of primary tumor or metastasis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05089916
Study type Interventional
Source AIO-Studien-gGmbH
Contact Sophie Worthmann
Phone +49 30 8145 344 61
Email sophie.worthmann@aio-studien-ggmbh.de
Status Recruiting
Phase Phase 2
Start date January 20, 2022
Completion date December 2026
View Details
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