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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorTata Memorial Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Patients with ECOG performance status of 0-2

Patients with pathologically proven diagnosis of NSCLC

Patients with positive oncogene mutation status (EGFR/ALK)

Disqualifiers

Patients with CSF dissemination only without any parenchymal brain metastases

Patients with brain metastases in the brain stem

Patients with prior history of radiation therapy to the brain

Patient not suitable for TKI therapy as per the medical oncologist

Trial design

Treatments tested in this trial

  • Stereotactic radiosurgery/whole brain radiotherapy
  • Tyrosine kinase inhibitor

Treatment groups

190 Participants
are divided into 2 treatment groups

Sponsors and collaborators