Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT

Tyrosine Kinase Inhibitors (TKIs) especially higher generation TKI have higher CNS penetration rates and have shown favorable response rates in brain metastases. Brain radiotherapy/surgery is the standard treatment in brain metastases especially symptomatic metastases, however, the role of local treatment especially in driver mutation-positive non-small cell lung cancer with asymptomatic brain metastases is being questioned given their potential side effects. No randomized trial has shown the superiority of early vs delayed cranial RT in asymptomatic BM of driver mutated NSCLC.

NCT Number	NCT05236946
Lead Sponsor	Tata Memorial Hospital
Conditions	Asymptomatic Brain Metastases, Driver Mutation Positive Non-small Cell Lung Cancer
Enrollment	190 participants
Start Date	2020-11-10
Primary Completion	2025-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-09-10