Comparing observation to upfront cranial radiation in patients with specific lung cancer and brain metastases
Official title: Observation or Upfront Cranial RT in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases: A Phase III Randomized Controlled Trial
Run by Tata Memorial Hospital · NCT05236946 · Data updated 2026-11-12
This study is testing whether giving radiation treatment right away helps people with specific lung cancer and brain metastases live longer and feel better compared to just watching and waiting.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 190 (estimated) |
| Sponsor | Tata Memorial Hospital Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Mumbai, Maharashtra) |
| Status | Recruiting |
| Started | November 10, 2020 |
| Main results expected | December 2025 |
| Study ends | December 2026 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT05236946 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with pathologically confirmed NSCLC, positive for EGFR or ALK mutations, and asymptomatic brain metastases.
✕Probably not a fit
Patients with brain stem metastases, prior radiation therapy to the brain, or those not suitable for TKI therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase III clinical trial investigates the effectiveness of upfront cranial radiotherapy versus observation in patients with asymptomatic brain metastases and driver mutation-positive non-small cell lung cancer (NSCLC). The study aims to determine whether early treatment with stereotactic radiosurgery or whole brain radiotherapy provides any advantages over delaying treatment, especially considering the potential side effects of radiation. Participants will receive either the radiation treatment or continue with their current therapy, which may include tyrosine kinase inhibitors known for their efficacy in treating brain metastases. The trial will assess outcomes related to disease progression and overall survival.
Why it matters
Potential benefit: If successful, this study could help determine the optimal timing for cranial radiation therapy in patients with asymptomatic brain metastases, potentially improving patient outcomes.
How similar studies have gone: While the role of early versus delayed cranial radiation in asymptomatic brain metastases is still being explored, no randomized trials have definitively shown superiority, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Tata Memorial Hospital
Mumbai, Maharashtra, India Recruiting
Study contacts
- Study coordinator: Anil Tibdewal, MD
- Email: aniltibdewal@gmail.com
- Phone: 9122 2417 7000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.