A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain
ICON-RT: Intracranial Consolidation and Deferral of Radiation Therapy in Patients Receiving Approved CNS-Active Systemic Therapeutics
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The researchers will measure quality of life by having participants complete questionnaires."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
The researchers are doing this study is to find out whether treating brain metastasis with SRS after 3 months of therapy with osimertinib is better than treating with osimertinib alone in people with NSCLC. The researchers will also look at how the study intervention impacts participants' quality of life. The researchers will measure quality of life by having participants complete questionnaires.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Participant Inclusion Criteria: Screening * Age ≥ 18 years * Non-small cell lung cancer (NSCLC) with somatic activating mutation in EGFR diagnosis, confirmed at enrolling institution * At least one intact brain metastasis at baseline prior to TKI therapy initiation, visible on MRI brain with contrast (but without a minimum diameter requirement) * Either TKI-naïve or started TKI ≤ 3-months prior (with documented start date and available imaging prior to TKI start) Participant Exclusion Criteria: Screening * Unable to undergo contrast-enhanced MRI brain * Prior brain-directed radiotherapy * Evidence of leptomeningeal disease on MRI total spine and/or lumbar puncture cytology. The latter are not mandated by protocol but are rather at the discretion of the treating medical team as clinically indicated. * Neurologic symptoms or presence of a lesion in the brainstem, motor strip, or other eloquent brain area that is felt to warrant immediate intervention with SRS * Active hematologic malignancy or a second solid tumor histology with known CNS tropism * Patients who have undergone a therapeutic craniotomy for resection of one or more symptomatic brain metastasis are ineligible unless one or more additional intact BM remain unresected, and meets size criteria (e.g., a patient with removal of a 3cm symptomatic brain metastasis, but has an additional visible lesion remaining post-operatively, remains eligible for the study). * Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. * Pregnant women or women who are breastfeeding or of childbearing potential. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 3 months after last treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent) Participant Inclusion Criteria: Randomization \- Presence of detectable and non-progressing BM lesions on imaging consistent with viable residual disease Participant Exclusion Criteria: Randomization * Progressive Disease (PD) with multiple lesions and/or other features that would warrant a change in systemic therapy, as determined by the primary treating provider * Presence of BM not deemed safely treatable with SRS, as determined by a radiation oncologist * Intracranial Complete Response (CR) * More than 20 visible residual brain metastases at the time of enrollment (i.e. after initial treatment with TKI). However, no upper limit on the number of visible brain metastases is set at the time of initial diagnosis prior to treatment with TKI. For example, a patient who had 35 visible brain metastases at the time of diagnosis, but after three months of treatment with TKI had 10 visible brain metastases remaining will be eligible for enrollment and randomization
Study sites (8)
FL
- BAPTIST ALLIANCE - MCI (Data Collection Only) · Miami, FL 33143Rupesh Kotecha, MD · Study contact · 786-596-2000More trials in Miami
NJ
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) · Basking Ridge, NJ 07920Luke Pike, MD · Study contact · 212-639-8157More trials in Basking Ridge
- Memorial Sloan Kettering Monmouth (All Protocol Activities) · Middletown, NJ 07748Luke Pike, MD · Study contact · 212-639-8157More trials in Middletown
- Memorial Sloan Kettering Bergen (All Protocol Activities) · Montvale, NJ 07645Luke Pike, MD · Study contact · 212-639-8157More trials in Montvale
NY
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) · Commack, NY 11725Luke Pike, MD · Study contact · 212-639-8157More trials in Commack
- Memorial Sloan Kettering Westchester (All Protocol Activities) · Harrison, NY 10604Luke Pike, MD · Study contact · 212-639-8157More trials in Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) · New York, NY 10065Luke Pike, MD · Study contact · 212-639-8157More trials in New York
- Memorial Sloan Kettering Nassau (All Protocol Activities) · Rockville Centre, NY 11553Luke Pike, MD · Study contact · 212-639-8157More trials in Rockville Centre