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

ConditionsMetastatic NSCLC - Non-Small Cell Lung CancerOligoProgressive Metastatic Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

More than 5 extracranial sites of progressive disease.

Pregnant.

Leptomeningeal disease.

Serious health issues that prevent radiotherapy, like ataxia-telangiectasia or scleroderma.

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiotherapy

    Radiation

    SBRT/high-dose radiotherapy Standard of care targeted therapy

  • Radiotherapy

    Radiation

    SBRT/high-dose radiotherapy Second-line targeted therapy

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Decreasing or undetectable ctDNA levels after SBRT/high-dose radiotherapyExperimental treatment 1 intervention
Group B: Persistent or increasing ctDNA levels after SBRT/high-dose radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 year

Secondary outcomes

1

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.

Time frame
1 year
2

Acute and Late Toxicities

For SBRT combined with TKI (using CTCAE Version 5.0)

Time frame
1 year
3

Reported Adverse Events

PRO-CTCAE Questionnaire

Time frame
1 year
4

Quality of Life Outcome

QLQ-LC13 Questionnaire

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: