Metastatic NSCLC - Non-Small Cell Lung Cancer, OligoProgressive Metastatic Disease
Conditions
Brief summary
This is an open-label, prospective single arm Phase II trial that investigates the role of ablative stereotactic body radiation therapy (SBRT) in oncogene driven metastatic non-small cell lung cancer (mNSCLC) patients with oligoprogressive disease (OPD) on targeted therapy (TKI) followed by circulating tumor DNA (ctDNA) analysis for tailoring targeted therapies.
Interventions
RADIATIONRadiotherapy
SBRT/high-dose radiotherapy Standard of care targeted therapy
Sponsors
University Health Network, Toronto
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older. 2. Able to do most daily activities (ECOG 0-2). 3. Able and willing to sign an informed consent form to join the study. 4. Metastatic disease detected on imaging and histologically confirmed NSCLC on first-line TKI therapy 5. Willing to give a blood sample for ctDNA analysis. 6. No upper limit to the number of total metastatic sites, but a maximum of five progressive metastatic sites, inclusive of primary disease and metastatic lesions, all of which must be extracranial 7. Prior radiation therapy near progressive lesions is allowed if applicable. 8. All sites of oligoprogression that can be safely treated with SBRT or hypofractionated ablative radiotherapy 9. Oligoprogressive disease is evaluated independently for each lesion using specific criteria. 10. Stable brain metastases allowed if asymptomatic and do not require corticosteroids. 11. Oligoprogressive lesions previously treated with external beam radiation are eligible as long they are clinically asymptomatic, and re-treatment is possible according to the investigator. Prior conventional, non-stereotactic radiotherapy for palliative -purposes is allowed, and if the palliated lesion subsequently progressed but remains asymptomatic and does not require immediate radiotherapy, the lesion can still be counted toward one of the five oligoprogressive lesions 12. Participant is able (i.e. sufficiently fluent or with the assistance of a translator) and willing to complete the quality of life and/or health utility questionnaires in English 13. Accessible for treatment and follow-up.
Exclusion criteria
1. More than 5 extracranial sites of progressive disease. 2. Pregnant. 3. Leptomeningeal disease. 4. Serious health issues that prevent radiotherapy, like ataxia-telangiectasia or scleroderma. 5. Prior radiation therapy near the progressive lesion that would prevent treatment with SBRT due to exceeding limits of healthy tissue tolerance. 6. Any other condition that the investigator believes makes participation in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free-survival | 1 year | Progression-free-survival 1 (PFS1) will be determined from the first day of SBRT to oligoprogressive sites to the day of diagnosis of radiological progression in the subsequent imaging (irrespective of change in systemic therapy in group B, essentially second-line) or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subsequent progression-free-survival | 1 year | Subsequent PFS will be calculated from the date of first radiological progression after SBRT to second radiological progression or change to 3rd line systemic therapy or death or loss to follow-up, whichever comes first. |
| Acute and Late Toxicities | 1 year | For SBRT combined with TKI (using CTCAE Version 5.0) |
| Reported Adverse Events | 1 year | PRO-CTCAE Questionnaire |
| Quality of Life Outcome | 1 year | QLQ-LC13 Questionnaire |
Countries
Canada
Contacts
CONTACTC. Jillian Tsai
Outcome results
None listed