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Not yet recruiting NCT06813664

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

Phase II Interventional Metastatic NSCLC - Non-Small Cell Lung Cancer OligoProgressive Metastatic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiotherapy, Radiotherapy.
Who it may be relevant to
Registry conditions: Metastatic NSCLC - Non-Small Cell Lung Cancer, OligoProgressive Metastatic Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Radiation Radiotherapy
    SBRT/high-dose radiotherapy Standard of care targeted therapy
  • Radiation Radiotherapy
    SBRT/high-dose radiotherapy Second-line targeted therapy

Primary outcome measures

  • Progression-free-survival [Time frame: 1 year]
Secondary outcome measures (5)
  • Subsequent progression-free-survival [Time frame: 1 year]
  • Acute and Late Toxicities [Time frame: 1 year]
  • Reported Adverse Events [Time frame: 1 year]
  • Quality of Life Outcome [Time frame: 1 year]
  • Quality of Life Outcome [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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 non-small cell lung cancer (NSCLC) with either an EGFR mutation or ALK rearrangement confirmed by imaging and biopsy.
  • Eligible for second-line therapy or targeted treatment (TKI) if in Group B.
  • Willing to give a blood sample for ctDNA analysis.
  • No limit to how many metastatic sites, but up to 5 progressive lesions that do not require immediate treatment.
  • Prior radiation therapy near progressive lesions is allowed if applicable.
  • Cancer lesions must be treatable with specific radiotherapy methods (like SBRT or ablative therapy).
  • Oligoprogressive disease is evaluated independently for each lesion using specific criteria.
  • Stable brain metastases allowed if asymptomatic and do not require corticosteroids.
  • Prior treatment with radiation for oligoprogressive lesions is allowed as long as they remain asymptomatic and re-treatment is possible.
  • 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.
  • Able and willing to complete quality of life and health utility questionnaires in English, French, or Spanish.
  • Accessible for treatment and follow-up.

Exclusion criteria

  • 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 psychological, social, or geographic issues that could make it difficult to comply with the study.
  • Any other condition that the investigator believes makes participation in the study inappropriate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network — Toronto

Identifiers

NCT: NCT06813664 · 24-6091

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗