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
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.