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Clinical Trials in India / NCT05236946
Recruiting Phase 3

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

NCT05236946 · tracked via the Priya Life Science India tracker
Sponsor
Tata Memorial Hospital
Phase
Phase 3
Started
2020-11-10
Last updated
2025-09-10

Condition(s) studied

Asymptomatic Brain MetastasesDriver Mutation Positive Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Stereotactic radiosurgery/whole brain radiotherapyTyrosine kinase inhibitor

Stereotactic radiosurgery/whole brain radiotherapy: SRS/ WBRT for asymptomatic brain metastases depending on the number of brain metastases

Tyrosine kinase inhibitor: TKI

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years 2. Patients with ECOG performance status of 0-2 3. Patients with pathologically proven diagnosis of NSCLC 4. Patients with positive oncogene mutation status (EGFR/ALK) 5. Patients with radiologically confirmed parenchymal brain metastases 6. Patients with asymptomatic Synchronous or Metachronous brain metastases 7. Patients willing for written informed consent and must be willing to comply with the specified follow-up schedule Exclusion Criteria: 1. Patients with CSF dissemination only without any parenchymal brain metastases 2. Patients with brain metastases in the brain stem 3. Patients with prior history of radiation therapy to the brain 4. Patient not suitable for TKI therapy as per the medical oncologist 5. Pregnant or lactating females

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tata Memorial Hospital Mumbai Maharashtra Recruiting

More Tata Memorial Hospital trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05236946 on ClinicalTrials.gov ↗ ← All trials in India