Actively Recruiting
Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT
Led by Tata Memorial Hospital · Updated on 2025-09-10
190
Participants Needed
1
Research Sites
316 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status of 0 to 2
- Pathologically confirmed diagnosis of non-small cell lung cancer
- Presence of positive oncogene mutation status (EGFR or ALK)
- Radiologically confirmed parenchymal brain metastases
- Asymptomatic synchronous or metachronous brain metastases
- Willingness to provide written informed consent and comply with follow-up schedule
You will not qualify if you...
- Only cerebrospinal fluid dissemination without parenchymal brain metastases
- Brain metastases located in the brain stem
- Prior history of radiation therapy to the brain
- Not suitable for tyrosine kinase inhibitor therapy as determined by medical oncologist
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Actively Recruiting
Research Team
A
Anil Tibdewal, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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