NCI-2019-02609

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)

This research study compares the new treatment (durvalumab with SBRT) with the current standard of care (placebo with SBRT) to evaluate its effectiveness and safety in a larger group of patients. Durvalumab is an immunotherapy drug that works by blocking a protein called PD-L1 on cancer cells, allowing the immune system to recognize and attack the cancer cells more effectively. Stereotactic Body Radiation Therapy (SBRT) is a type of radiation therapy that delivers high doses of radiation precisely to the tumor while minimizing damage to surrounding healthy tissue. It is commonly used in the treatment of early-stage non-small cell lung cancer. The study includes patients with stage I/II, lymph-node negative non-small cell lung cancer. These patients have tumors that are localized and have not spread to nearby lymph nodes. The primary objective of PACIFIC-4 (RTOG-3515) is to evaluate whether adding durvalumab to SBRT improves outcomes compared to SBRT alone in patients with early-stage non-small cell lung cancer. This includes assessing progression-free survival (the time until the cancer worsens), overall survival, and the safety profile of the treatment regimen.

immunotherapy: The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

non-small cell lung cancer (NSCLC): A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

early-stage: Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT03833154

Clinical Trial Site: Einstein

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