RecruitingPhase 2NCT05277844

Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC

A Phase II Randomized Controlled Trial of TKI Alone Versus TKI and Local Consolidative Radiation Therapy in Oncogene Driver Mutated Oligo Metastatic Non Small Cell Lung Cancer Patients


Sponsor

Tata Memorial Hospital

Enrollment

106 participants

Start Date

Nov 11, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase II randomized controlled trial of TKI Alone versus TKI and Local Consolidative Radiation Therapy in oncogene driver mutated oligo metastatic Non-small cell lung cancer patients.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding targeted radiation to remaining cancer sites (local consolidative therapy) improves outcomes compared to continuing targeted drug therapy (TKI) alone in patients with metastatic non-small cell lung cancer (NSCLC) with 1–5 sites of spread. **You may be eligible if...** - You are 18 or older with confirmed NSCLC and a driver mutation (EGFR or ALK/ROS) - You have 1–5 sites of metastatic disease (fewer than 3 lesions per organ) - You have already received 2–4 months of TKI therapy without your cancer progressing - Your performance status is good (ECOG 0–2) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - Your cancer has progressed on TKI therapy - You have more than 5 metastatic sites, or 4 or more lesions in a single organ - You do not have a targetable driver mutation (EGFR or ALK/ROS) - You are pregnant or breastfeeding 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

RADIATIONLocal Consolidative Radiation Therapy

Local consolidative radiation therapy to loco-regional disease and all Oligometastatic sites in addition to TKI

DRUGTKI

TKI


Locations(1)

Tata Memorial Hospital

Mumbai, Maharashtra, India

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NCT05277844


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