NCT06813664Not yet recruitingPhase 2
ctDNA-Guided CURB for OPD mNSCLC on TKI (CURB-TKI)
Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Non-Small-Cell Lung Cancer on Tyrosine Kinase Inhibitor
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 24 Jan 2025
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Lung cancer
- NCT number
- NCT06813664
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 Dec 2026 to the primary completion date, 1 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious health issues that prevent radiotherapy, like ataxia-telangiectasia or scleroderma.
- Prior radiation therapy near the progressive lesion that would prevent treatment with SBRT due to exceeding limits of healthy tissue tolerance.
Other illness
- More than 5 extracranial sites of progressive disease.
- Leptomeningeal disease.
- Any other condition that the investigator believes makes participation in the study inappropriate.
Other
- Pregnant.
Who the study is looking for
- Age 18 or older.
- Able to do most daily activities (ECOG 0-2).
- Able and willing to sign an informed consent form to join the study.
- Metastatic disease detected on imaging and histologically confirmed NSCLC on first-line TKI therapy
- Willing to give a blood sample for ctDNA analysis.
- 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
- Prior radiation therapy near progressive lesions is allowed if applicable.
- All sites of oligoprogression that can be safely treated with SBRT or hypofractionated ablative radiotherapy
- Oligoprogressive disease is evaluated independently for each lesion using specific criteria.
- Stable brain metastases allowed if asymptomatic and do not require corticosteroids.
- 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
- 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
- Accessible for treatment and follow-up.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.