NCT05089916

Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• NSCLC
• EGFR Positive Non-small Cell Lung Cancer
• Oligoprogression

Interventions

Type	Name	Description
DRUG	Osimertinib	Osimertinib: according to its marketing authorization, i.e. at daily doses of 80 mg, for a maximum of 12 months within the study.
RADIATION	Radiotherapy	Radiotherapy: according to standard of care The target population will comprise 3 parallel cohorts, for cohort 1 and 3 a minimum of 10 subjects is planned to be enrolled: 1. Irradiation of bone, solid organ (non-lung, non-brain) or soft-tissue metastases 2. Irradiation of brain metastases (initial lesion size \< 3 cm) 3. Irradiation of lung lesions (primary tumor or metastases, lesion size \< 5 cm)

Timeline

• Start date: 2022-01-20
• Primary completion: 2026-03-01
• Completion: 2027-03-01
• First posted: 2021-10-22
• Last updated: 2026-01-14

Locations

1 site across 1 country: Germany