NCT05236946

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

Observation or Upfront Cranial RT in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases: A Phase III Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Tata Memorial Hospital · Other Government
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Asymptomatic Brain Metastases
• Driver Mutation Positive Non-small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic radiosurgery/whole brain radiotherapy	SRS/ WBRT for asymptomatic brain metastases depending on the number of brain metastases
DRUG	Tyrosine kinase inhibitor	TKI

Timeline

• Start date: 2020-11-10
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2022-02-11
• Last updated: 2025-09-10

Locations

1 site across 1 country: India