Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT
Recruiting now · Phase 3
Conditions studied: Asymptomatic Brain Metastases, Driver Mutation Positive Non-small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT05236946
- Run by
- Tata Memorial Hospital
- People needed
- 190
- Starts
- 2020-11-10
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-09-10
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Tata Memorial Hospital — Mumbai, Maharashtra, India (enrolling)
Full record on ClinicalTrials.gov
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