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

NCT05236946 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-09-10

No results posted yet for this study

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

RADIATION

Stereotactic radiosurgery/whole brain radiotherapy

SRS/ WBRT for asymptomatic brain metastases depending on the number of brain metastases

DRUG

Tyrosine kinase inhibitor

TKI

Sponsors & Collaborators

  • Tata Memorial Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05236946 on ClinicalTrials.gov