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Not yet taking people in CanadaPhase 2

ctDNA-Guided CURB for OPD mNSCLC on TKI (CURB-TKI)

Key facts

Where
Toronto, CanadaSee the site
Phase
Phase 2

Where in Canada

  • Radiation Medicine Program, Princess Margaret Cancer Centre, University Health NetworkToronto, CanadaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University Health Network, Toronto
Trial code
NCT06813664
Record updated
4 November 2026
Original description
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.Read full original descriptionShow less

Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Non-Small-Cell Lung Cancer on Tyrosine Kinase Inhibitor

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.

Inclusion: 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.

Exclusion: 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; More than 5 extracranial sites of progressive disease; Leptomeningeal disease; Any other condition that the investigator believes makes participation in the study inappropriate; Pregnant.

ClinicalTrials.gov NCT06813664