Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT

Tata Memorial Hospital

Status and phase: Enrolling; Phase 3

Conditions: Driver Mutation Positive Non-small Cell Lung Cancer; Asymptomatic Brain Metastases

Treatments: Drug: Tyrosine kinase inhibitor; Radiation: Stereotactic radiosurgery/whole brain radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05236946

IEC/3470 (Other Identifier)

CTRI/2020/08/027279

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Upfront Cranial Radiotherapy

Active Comparator group

Description:

Stereotactic radiosurgery or Whole brain radiotherapy upfront in asymptomatic brain metastases

Treatment:

Radiation: Stereotactic radiosurgery/whole brain radiotherapy

Drug: Tyrosine kinase inhibitor

Observation (Delayed Cranial Radiotherapy)

Experimental group

Description:

Observation (Delayed Cranial radiotherapy) of Asymptomatic brain metastases

Treatment:

Drug: Tyrosine kinase inhibitor