RecruitingPhase 2NCT06305715

Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X)


Sponsor

Medical College of Wisconsin

Enrollment

34 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This prospective, two-part, single-arm, phase II trial is designed to evaluate whether the use of definitive radiation to the primary lung lesion prolongs progression-free survival (PFS) in treatment-naïve, metastatic, driver-mutated non-small cell lung cancers (NSCLC) patients who are subsequently placed on a tyrosine kinase inhibitor (TKI).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving targeted radiation to the main lung tumor before starting a targeted therapy drug (TKI) in people with advanced, mutation-driven non-small cell lung cancer (NSCLC) can delay cancer progression. **You may be eligible if...** - You are 18 years or older - You have been confirmed to have non-small cell lung cancer with a specific driver mutation - You have advanced disease (stage IV or non-resectable stage IIIB/C) - You have an identifiable primary tumor in the lung - You have not yet received any targeted therapy for NSCLC (you may have had up to 2 cycles of standard chemotherapy) - You have not previously had radiation to the primary lung lesion **You may NOT be eligible if...** - You have already started targeted therapy for NSCLC - You have had prior radiation to the main lung tumor - Your cancer does not have a targetable driver mutation - Your general health is not sufficient to tolerate radiation and targeted therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERadiation Therapy

Enrolled subjects will be given radiation doses, at the discretion of the treating physicians, that range from 24-60 Gy in 1-15 fractions with a minimum biologically effective dose (BED\^10) of 58 Gy.

DRUGTargeted TKI therapy

Immediately following radiation therapy, subjects with an actionable driver mutation will receive a standard-of-care TKI. The choice of TKI will be at the discretion of the treating oncologist.


Locations(1)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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NCT06305715


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