A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for patients with non-small cell lung cancer (NSCLC) that has spread to the brain. Researchers want to find out if using a special type of radiation therapy called stereotactic radiosurgery (SRS) after three months of treatment with a drug called osimertinib is more effective than just continuing with osimertinib alone. They will also check how these treatments affect the participants' quality of life by having them fill out questionnaires.

To be eligible for the study, participants must be at least 18 years old and have NSCLC with a specific genetic change. They should have at least one brain metastasis (cancer spread to the brain) that is 1 cm or larger. Patients should not have had prior radiation therapy to the brain or certain other conditions that might complicate treatment. Those who join the trial can expect to receive either the SRS treatment or continue with osimertinib alone, and their progress will be closely monitored throughout the study. It’s important for participants to follow the study guidelines and stay in touch with their medical team.

Gender

ALL

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 measuring ≥1 cm measurable by RANO-BM at baseline prior to TKI therapy initiation
• • 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 1.25cm 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