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

A Phase II Clinical Trial of Durvalumab (MEDI4736) and Fractionated Stereotactic Radiotherapy (fSRT) Vs. Personalized Ultra-Fractionated Stereotactic Adaptive Radiotherapy (PULSAR) for the Treatment of Brain Metastases from Non-Small Cell Lung Cancer (NSCLC)

NCT04889066•University of Texas Southwestern Medical Center

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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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•* Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
+14 more criteria

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 situations that, in the opinion of the investigator, would limit compliance with study requirements, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
•Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
•Administration of one or more lines of systemic therapy for the diagnosis of metastatic non-small cell lung cancer
•Prior receipt of systemic therapy for the management of high-risk early stage or locally advanced non-small cell lung cancer, prior to the development of metastatic disease, would not count towards the number of receipt of systemic therapy
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab or other agents used in study
•Male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy
•Participation in another clinical study with an investigational product during the last 1 month
+2 more criteria

Key Dates

Start Date

October 1, 2024

Primary Completion Date

January 1, 2025

Completion Date

January 1, 2025

Last Updated

December 20, 2024

Conditions

Brain Metastases from Non-small Cell Lung Cancer

Interventions

Stereotactic Radiation Therapy

RADIATION

Durvalumab

DRUG

Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung Cancer

NCT01657799

Brain Metastases From Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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