STICk-IM NSCLC (Non-Small Cell Lung Cancer with Brain Metastases) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the timing of radiation and immunotherapy can improve outcomes.

What is the Condition Being Studied?

Lung cancer that has spread to the brain

Who Can Participate in the Study?

Adults ages 18 and older who:
- Have between 1-15 brain metastases
- Primary tumor origin is non-small cell lung cancer
- Plan to have immunotherapy
- Are able to have an MRI
- Have not received whole brain radiation therapy

Age Group

What is Involved?

If you choose to join this study, you will:
- Be randomized (like flipping a coin) into Group 1 or Group 2:
-- Group 1 will go as follows:
--- Have stereotactic radiation therapy (SRS) right away in up to 5 doses
--- Receive immunotherapy later after the SRS
-- Group 2 will go as follows:
---- Receive immunotherapy right away
---- Receive SRS later, but only if your cancer progresses

All study participants will:
- Answer questionnaires
- Have neurocognitive tests
- Have blood draws

Your participation will last for about 1 year. You may be asked to come for one more visit between year 1 and year 2, but only if your cancer progresses.

Study Details

Full Title
A randomized, Phase II trial of SRS Timing with Immune Checkpoint Inhibition in patients with Brain Metastases from non-small cell lung cancer (STICk-IM NSCLC)
Principal Investigator
Radiation Oncologist
Protocol Number
IRB: PRO00106340
NCT: NCT04650490
Phase II
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center