Metastatic NSCLC - Non-Small Cell Lung CancerPhase 2CURB-TKINCT06813664
ctDNA-Guided CURB for OPD mNSCLC on TKI (CURB-TKI)
A Phase 2 study testing Radiotherapy in people with Metastatic NSCLC - Non-Small Cell Lung Cancer and OligoProgressive Metastatic Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic NSCLC - Non-Small Cell Lung Cancer, OligoProgressive Metastatic Disease
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 1 Apr 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- More than 5 extracranial sites of progressive disease.
- Pregnant.
- Leptomeningeal disease.
- 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.
- Any other condition that the investigator believes makes participation in the study inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network
Toronto, Ontario, M5G 2M9
Jillian Tsai, 416-946-4501 ext. 4866, jillian.tsai@uhn.ca
About this study
Official title: 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.
- Being tested
- Radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
SBRT/high-dose radiotherapy Standard of care targeted therapy
RadiotherapyRadiation
SBRT/high-dose radiotherapy Second-line targeted therapy
| Study group | Role | What they receive |
|---|---|---|
| Decreasing or undetectable ctDNA levels after SBRT/high-dose radiotherapy | Experimental | This group continues the same first-line standard of care or targeted systemic therapy after completion of SBRT. Receives: Radiation: Radiotherapy |
| Persistent or increasing ctDNA levels after SBRT/high-dose radiotherapy | Experimental | This group of patients will be switched to a different targeted therapy (second line) or standard of care systemic therapy after completion of SBRT. Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 1 year
Acute and Late Toxicities
For SBRT combined with TKI (using CTCAE Version 5.0)
Measured: 1 year
Reported Adverse Events
PRO-CTCAE Questionnaire
Measured: 1 year
Quality of Life Outcome
QLQ-LC13 Questionnaire
Measured: 1 year
Quality of Life Outcome
EORTC-QLQ-C15 Questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic NSCLC - Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813664
- Sponsor's protocol ID
- 24-6091
- Acronym
- CURB-TKI
- Status last verified
- Aug 2026
- First submitted
- 24 Jan 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No