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Clinical Trial NCT06813664 (CURB-TKI) for Metastatic NSCLC - Non-Small Cell Lung Cancer, OligoProgressive Metastatic Disease is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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ctDNA-Guided CURB for OPD mNSCLC on TKI (CURB-TKI) Phase 2 60 Targeted Therapy Open-Label

Not yet recruiting
Clinical Trial NCT06813664 (CURB-TKI) is designed to study Treatment for Metastatic NSCLC - Non-Small Cell Lung Cancer, OligoProgressive Metastatic Disease. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 April 2026 until the study accrues 60 participants. Led by University Health Network, Toronto, this study is expected to complete by 1 April 2028. The latest data from ClinicalTrials.gov was last updated on 4 March 2026.
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.
Official Title

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

Conditions
Metastatic NSCLC - Non-Small Cell Lung CancerOligoProgressive Metastatic Disease
Other Study IDs
  • CURB-TKI
  • 24-6091
NCT ID Number
NCT06813664
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-04
Completion Date (Estimated)
2028-04-01
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalDecreasing or undetectable ctDNA levels after SBRT/high-dose radiotherapy
This group continues the same first-line standard of care or targeted systemic therapy after completion of SBRT.
Radiotherapy
SBRT/high-dose radiotherapy Standard of care targeted therapy
ExperimentalPersistent or increasing ctDNA levels after SBRT/high-dose radiotherapy
This group of patients will be switched to a different targeted therapy (second line) or standard of care systemic therapy after completion of SBRT.
Radiotherapy
SBRT/high-dose radiotherapy Second-line targeted therapy
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Progression-free-survival
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
1 year
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Subsequent progression-free-survival
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.
1 year
Acute and Late Toxicities
For SBRT combined with TKI (using CTCAE Version 5.0)
1 year
Reported Adverse Events
PRO-CTCAE Questionnaire
1 year
Quality of Life Outcome
QLQ-LC13 Questionnaire
1 year
Quality of Life Outcome
EORTC-QLQ-C15 Questionnaire
1 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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 non-small cell lung cancer (NSCLC) with either an EGFR mutation or ALK rearrangement confirmed by imaging and biopsy.
  5. Eligible for second-line therapy or targeted treatment (TKI) if in Group B.
  6. Willing to give a blood sample for ctDNA analysis.
  7. No limit to how many metastatic sites, but up to 5 progressive lesions that do not require immediate treatment.
  8. Prior radiation therapy near progressive lesions is allowed if applicable.
  9. Cancer lesions must be treatable with specific radiotherapy methods (like SBRT or ablative therapy).
  10. Oligoprogressive disease is evaluated independently for each lesion using specific criteria.
  11. Stable brain metastases allowed if asymptomatic and do not require corticosteroids.
  12. Prior treatment with radiation for oligoprogressive lesions is allowed as long as they remain asymptomatic and re-treatment is possible.
  13. Prior non-stereotactic radiation for palliative purposes is allowed, and if the lesion later progresses but is still asymptomatic and does not require immediate therapy, it can count towards the 5 oligoprogressive lesions.
  14. Able and willing to complete quality of life and health utility questionnaires in English, French, or Spanish.
  15. Accessible for treatment and follow-up.

  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 psychological, social, or geographic issues that could make it difficult to comply with the study.
  7. Any other condition that the investigator believes makes participation in the study inappropriate.
University Health Network, Toronto logoUniversity Health Network, Toronto
Study Central Contact
Contact: C. Jillian Tsai, 416-946-4501, [email protected]
1 Study Locations in 1 Countries

Ontario

Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, M5G 2M9, Canada
Jillian Tsai, Contact, 416-946-4501, [email protected]