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

NCT ID: NCT05236946

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-10
• Study Completion Date: 2026-12-31

Brief Summary

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Upfront Cranial Radiotherapy

Stereotactic radiosurgery or Whole brain radiotherapy upfront in asymptomatic brain metastases

Group Type: ACTIVE_COMPARATOR

Stereotactic radiosurgery/whole brain radiotherapy

Intervention Type: RADIATION

SRS/ WBRT for asymptomatic brain metastases depending on the number of brain metastases

Tyrosine kinase inhibitor

Intervention Type: DRUG

TKI

Observation (Delayed Cranial Radiotherapy)

Observation (Delayed Cranial radiotherapy) of Asymptomatic brain metastases

Group Type: EXPERIMENTAL

Tyrosine kinase inhibitor

Intervention Type: DRUG

TKI

Interventions

Stereotactic radiosurgery/whole brain radiotherapy

SRS/ WBRT for asymptomatic brain metastases depending on the number of brain metastases

Intervention Type: RADIATION

Tyrosine kinase inhibitor

TKI

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tata Memorial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anil Tibdewal

Dr. Anil Tibdewal, Associate Professor, Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tata Memorial Hospital

Mumbai, Maharashtra, India

Site Status: RECRUITING

Countries

India

Central Contacts

Anil Tibdewal, MD

Role: CONTACT

aniltibdewal@gmail.com

9122 2417 7000 ext. 7030

Facility Contacts

Dr. Anil Tibdewal, MD

Role: primary

aniltibdewal@gmail.com

Other Identifiers

IEC/3470

Identifier Type: OTHER

Identifier Source: secondary_id

CTRI/2020/08/027279

Identifier Type: -

Identifier Source: org_study_id