WithdrawnPhase 2

Durvalumab (MEDI4736) and Radiosurgery (fSRT Vs. PULSAR) for the Treatment of Non-Small Cell Lung Cancer Brain Metastases

Stopped: Project Never Initiated since sponsor stopped support for the trial- no human subjects were enrolled and no data regarding humans was collected or studied

0Started 2024-10-01

Plain-language summary

This is a research study to find out if the new anti-cancer drug Durvalumab combined with radiation therapy to the brain will work in treating brain metastases from non-small cell lung cancer (NSCLC). Focused, highly precise radiation therapy to the brain, known as stereotactic radiosurgery (SRS), is a standard of care treatment that is commonly used for patients with metastatic lung cancer to the brain. It is standardly used as an alternative to surgery to eradicate the targeted tumours in the brain and prevent them from growing and causing symptoms. This study will look at the combination of the novel immunotherapy Durvalumab with two different ways of delivering SRS: 1) with each radiation treatment given every other day for 3 treatments with the first dose of Durvalumab (fSRT), or 2) with each radiation treatment, referred to as a "pulse," given every 4 weeks with each dose of Durvalumab for 3 treatments (PULSAR).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Biopsy-proven NSCLC primary with PD-L1 expression ≥ 1% * At least one previously untreated, asymptomatic brain metastases (\<=10 total) with at least one measurable (0.5 cm diameter or larger) as assessed by MRI * No prior systemic treatment for metastatic NSCLC. * age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Life expectancy greater than six (6) months * Adequate normal organ and marrow function * Body weight greater than 30 kg * Ability to understand and willingness to sign written informed consent Exclusion Criteria: * Brain metastases that are symptomatic and/or with recent (\<10 days) steroid use * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). * Subjects may not be receiving any other investigational agents for the treatment of the cancer under study. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situ…

What they're measuring

Intercranial clinical benefit

Timeframe: 6 months after initiation of treatment

Trial details

NCT IDNCT04889066

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01