Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study

Sponsor
AIO-Studien-gGmbH
Study ID
NCT05089916
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Osimertinib: according to its marketing authorization, i.e. at daily doses of 80 mg, for a maximum of 12 months within the study.
  • Radiotherapy — RADIATION
    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)

Study Details

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.

Key Dates

Start date
Jan 20, 2022
Status verified
Jan 2026
Primary completion
Mar 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Osimertinib plus Radiation
    Osimertinib 80 mg Radiation as per SOC

Primary Outcome Measure

Frequency, time of onset and severity of Adverse Events as assessed by investigator during osimertinib treatment and irradiation therapy [ Time Frame: 24 months ]

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