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

Study Purpose

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.#46;delayed cranial RT in asymptomatic BM of driver mutated NSCLC.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 99 Years
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05236946
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Tata Memorial Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	India
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Asymptomatic Brain Metastases, Driver Mutation Positive Non-small Cell Lung Cancer

Arms & Interventions

Arms

Active Comparator: Upfront Cranial Radiotherapy

Stereotactic radiosurgery or Whole brain radiotherapy upfront in asymptomatic brain metastases

Experimental: Observation (Delayed Cranial Radiotherapy)

Observation (Delayed Cranial radiotherapy) of Asymptomatic brain metastases

Interventions

Radiation: - Stereotactic radiosurgery/whole brain radiotherapy

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

Drug: - Tyrosine kinase inhibitor

TKI

Contact a Trial Team

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International Sites

Tata Memorial Hospital, Mumbai, Maharashtra, India

Status

Recruiting

Address

Tata Memorial Hospital

Mumbai, Maharashtra, 400012

Site Contact

Dr. Anil Tibdewal, MD

[email protected]

9122 2417 7000

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