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Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study

NCT05089916 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-14

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Amanda Tufman, Prof. Dr. · LMU Klinikum der Universität München

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2026-03-31
Completion
2027-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05089916 on ClinicalTrials.gov