Stereotactic Body Radiation Therapy for Early Stage Non-Small Cell Lung Cancer (POIMS Trial)

Palo Alto (17 mi)

Overseen byShalina Gupta-Burt, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: University of Kansas Medical Center

No Placebo Group

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?The current proposal is structured as a pilot trial to evaluate the impact of non-ablative SBRT (800 cGy X 3 fractions) as an immunomodulatory mechanism in patients with early stage NSCLC who are surgical candidates. Tumor, normal tissue and blood specimens will be analyzed for immunomodulatory changes including phenotypic changes in tumor cell surface marker expression, tumor and normal tissue microenvironment and gene expression profiles, serum/blood immune profile changes, and circulating tumor cell immunophenotypic and gene expression alterations. Published literature showed that cytotoxic doses of XRT may not elicit a clinically meaningful alteration in the immune profile. Further, studies using an animal model have concluded a fractionated regimen induces a greater abscopal effect than single dose radiation. Furthermore, research has shown a regimen of 800 cGy X 3 fractions yielded the most significant changes in the immune profile compared to 2000 cGy X 1 or 600 cGy X 5. The immune response within the tumor milieu is a complex dynamic process with an interplay among lymphocyte subsets, antigen presenting cells/dendritic cells, macrophages, and tumor cells. The interactions between the various components is orchestrated by a variety of extracellular and intracellular signaling pathways involving ligand and cell surface expression, cytokine release, and activation or inhibition of a variety of T cell subsets. In order to comprehensively define the immunomodulatory effect of three fractions of 800 cGy on the primary tumor, the investigators will analyze the following: tumor cell surface phenotype, tumor microenvironment immune profile and gene expression profile, T cell repertoire changes in tumor tissue and peripheral blood, and circulating tumor cell phenotype and gene expression profiles. Each of these components has been shown to be impacted by radiation in either a cell culture or animal model systems. By characterizing, quantitating and defining these changes related to three fractions of 800 cGy, it will directly provide important insights to inform rational uses of XRT and immunotherapy in the future.

Eligibility Criteria

This trial is for people with early stage Non-Small Cell Lung Cancer (NSCLC) who can have surgery to remove it. They should have a tumor that's at least 2 cm away from the central airways and 1 cm from the outer lung layer, as judged safe by a surgeon. Participants need good lung function and enough biopsy tissue for analysis before starting treatment. Those with past chest surgery or radiation, prior immunotherapy, autoimmune diseases, or current use of drugs that weaken the immune system cannot join.

Inclusion Criteria

My lung cancer is in an early stage (Stage I or II).

I am eligible for lung cancer surgery.

My lung lesion is located in a place that can be surgically removed.

Exclusion Criteria

I have received immunotherapy before.

I have had surgery on my lung or chest wall before.

I have had radiation therapy to my chest before.

I am currently taking drugs that suppress my immune system.

Treatment Details

The POIMS Trial is testing if a specific type of targeted radiation therapy called non-ablative SBRT (800 cGy in three sessions) can modify the body's immune response against NSCLC when given before surgery. Researchers will study changes in immune cells within both blood and tumor tissues to understand how this approach might improve cancer treatments.

1Treatment groups

Experimental Treatment

Group I: Non-ablative SBRTExperimental Treatment1 Intervention

Non-ablative SBRT (800 cGy X 3 fractions) given 5-7 days preoperatively in selected patients with stage I-II NSCLC

SBRT is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as SBRT for: