Comparing brain radiation with observation in lung cancer that has spread to the brain
Tests whether brain radiation right away helps adults with lung cancer and no brain symptoms.
Plain-language title generated from the registry record
Registry title: Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT
Key facts
- Where
- Mumbai, IndiaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT05236946, who can take part
Where in India
- Tata Memorial HospitalMumbai, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tata Memorial Hospital
- Trial code
- NCT05236946
- Record updated
- 10 September 2025
- Original description
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.Read full original descriptionShow less
Observation or Upfront Cranial RT in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases: A Phase III Randomized Controlled 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.
Inclusion: 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: Patients with prior history of radiation therapy to the brain; Patient not suitable for TKI therapy as per the medical oncologist; Patients with CSF dissemination only without any parenchymal brain metastases; Patients with brain metastases in the brain stem; Pregnant or lactating females.