NCT05236946RecruitingPhase 3
Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT
Observation or Upfront Cranial RT in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases: A Phase III Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 10 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 190 (estimated)
- First submitted
- 1 Feb 2022
- Start date
- 10 Nov 2020
- Primary completion date
- Dec 2025
- Lead sponsor
- Tata Memorial Hospital
- Diseases
- Lung cancer
- NCT number
- NCT05236946
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 190
- From 10 Nov 2020 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with prior history of radiation therapy to the brain
- Patient not suitable for TKI therapy as per the medical oncologist
Other
- Patients with CSF dissemination only without any parenchymal brain metastases
- Patients with brain metastases in the brain stem
- Pregnant or lactating females
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Memorial Hospital Coordinator of this site? Confirm its status | Mumbai | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.