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NCT Number: NCT05236946

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location status: Recruiting

Location contact

Dr. Anil Tibdewal, MD

CONTACT

[email protected]

Dr. Anil Tibdewal, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Patients with radiologically confirmed parenchymal brain metastases
  • Patients with asymptomatic Synchronous or Metachronous brain metastases
  • Patients willing for written informed consent and must be willing to comply with the specified follow-up schedule

Exclusion criteria

  • 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
  • Pregnant or lactating females

Treatment and study plan

Stereotactic radiosurgery/whole brain radiotherapy

Radiation

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

Tyrosine Kinase Inhibitor

Drug

TKI

Primary outcomes

  1. Intracranial progression free survival at 24 months

    Time frame: 2 year

    Intracranial progression free survival will be defined as the time from the date of randomization until the date of intracranial progression is documented. Death without intracranial progression will be considered as a competing event. Intracranial response will be graded as per the Response Assessment in Neuro-Oncology (RANO) guidelines for brain metastases

Secondary outcomes

  1. Overall Survival

    Time frame: Upto 5-year

    Overall survival will be defined as the time from randomization until the date of death from any cause in the presence or absence of recurrence.

  2. Progression free survival

    Time frame: upto 2 year

    Progression free survival will be defined from the date of randomization to the date of progression or the date of death whichever is earlier.

  3. Neurocognition toxicity

    Time frame: Upto 12 months

    Neuro-cognition assessment will be done using HVLT-R (Total Recall) at baseline and at 3, 6 and 12 months for assessable patients

  4. Toxicity using CTC v5.1

    Time frame: Upto 2 years

    Toxicity assessment will be defined as per the common terminology criteria version 5.0 at baseline and at subsequent follow up till 2 years

  5. Local Control

    Time frame: Upto 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Anil Tibdewal, MD

CONTACT

[email protected]

9122 2417 7000 ext. 7030

Sponsors and collaborators

Lead sponsor

Tata Memorial Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Feb 11, 2022
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.