Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asymptomatic Brain Metastases | — | UNRESOLVED | — |
| Driver Mutation Positive Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiosurgery/whole brain radiotherapy | Radiation | — | UNRESOLVED |
| Tyrosine kinase inhibitor | Drug | Tyrosine Kinase Inhibitor | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Upfront Cranial Radiotherapy
- description
- Stereotactic radiosurgery or Whole brain radiotherapy upfront in asymptomatic brain metastases
- interventionNames
- Radiation: Stereotactic radiosurgery/whole brain radiotherapy
- Drug: Tyrosine kinase inhibitor
- type
- EXPERIMENTAL
- label
- Observation (Delayed Cranial Radiotherapy)
- description
- Observation (Delayed Cranial radiotherapy) of Asymptomatic brain metastases
- interventionNames
- Drug: Tyrosine kinase inhibitor
Primary outcomes (1)
- measure
- Intracranial progression free survival at 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available