NCT05277844

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Tata Memorial Hospital · Other Government
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Randomization Arms: Eligible patients will be randomized in 1:1 ratio to TKI alone or TKI + LCRT. This will be an intention to treat randomized study. Arm 1: Continuation of TKI therapy alone Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to loc0-regional disease and 1-5 oligometastatic sites

Conditions

• Oligometastatic Disease
• Non-small Cell Lung Cancer
• Driver Mutation

Interventions

Type	Name	Description
RADIATION	Local Consolidative Radiation Therapy	Local consolidative radiation therapy to loco-regional disease and all Oligometastatic sites in addition to TKI
DRUG	TKI	TKI

Timeline

• Start date: 2019-11-11
• Primary completion: 2026-11-11
• Completion: 2027-11-11
• First posted: 2022-03-14
• Last updated: 2025-09-10

Locations

1 site across 1 country: India