Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study (ROSE)
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|ClinicalTrials.gov Identifier: NCT05089916|
Recruitment Status : Recruiting
First Posted : October 22, 2021
Last Update Posted : May 23, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|NSCLC EGFR Positive Non-small Cell Lung Cancer Oligoprogression||Drug: Osimertinib Radiation: Radiotherapy||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm, explorative, multi-center parallel cohort study|
|Masking:||None (Open Label)|
|Official Title:||Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study|
|Actual Study Start Date :||January 20, 2022|
|Estimated Primary Completion Date :||March 2026|
|Estimated Study Completion Date :||September 2026|
Experimental: Osimertinib plus Radiation
Osimertinib 80 mg Radiation as per SOC
Osimertinib: according to its marketing authorization, i.e. at daily doses of 80 mg, for a maximum of 12 months within the study.
Other Name: Tagrisso
Radiotherapy: according to standard of care
The target population will comprise 3 parallel cohorts, for each of which a minimum of 10 subjects is planned to be enrolled:
- Frequency, time of onset and severity of Adverse Events as assessed by investigator during osimertinib treatment and irradiation therapy [ Time Frame: 24 months ]Safety and tolerability (Frequency, time of onset and severity of Adverse Events, grading according to CTCAE V5.0), including pneumonitis, interstitial lung disease, radiation pneumonitis, radionecrosis and cardiac failure (congestive heart failure - CHF) as adverse events of special interest
- PFS [ Time Frame: 24 months ]Progression-free survival: calculated as PFS1, PFS2, PFS3, PFS0 to assess osimertinib treatment continued beyond several progression events entailing radiotherapy, and prior to first radiotherapy
- TTF [ Time Frame: 12 months ]Time to treatment failure
- Local tumor control [ Time Frame: 24 months ]Local tumor control
- OS [ Time Frame: 24 months ]Overall survival
- QoL [ Time Frame: 12 months ]Quality of Life assessed by EORTC QLQ-C30
- Blood sample analysis and biomarker assessment [ Time Frame: 24 months ]To explore blood-based biomarkers in this setting
- Tissue-based biomarkers [ Time Frame: Before or within 3 weeks after start of study treatment ]Optional tumor tissue analysis (pre-study FFPE sample) and biomarker correlation with patient baseline characteristics and outcomes
- Target volume of irradiation [ Time Frame: 28 days ]To investigate target volumes used.
- Type of irradiation [ Time Frame: 28 days ]To investigate types of irradiation (conventional vs. stereotactic)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05089916
|Contact: Sophie Worthmann||+49 30 8145 344 firstname.lastname@example.org|
|Contact: Amanda Tufman, PD Dr.||+49 89 4400 57545||Amanda.Tufman@med.uni-muenchen.de|
|LMU Klinikum der Universität München||Recruiting|
|München, Germany, 80336|
|Contact: Amanda Tufman, PD Dr. med. +49 89 44005 5445 Amanda.Tufman@med.uni-muenchen.de|
|Principal Investigator:||Amanda Tufman, PD Dr.||LMU Klinikum der Universität München|