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Radiation

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

N/A
Recruiting
Led By Shalina Gupta-Burt, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage I-II NSCLC
Candidate for oncologic surgery (lobectomy or sub lobar resection) for the lung cancer
Must not have
Prior immunotherapy
Prior history of lung/chest wall surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of radiation on the immune system in patients with early stage lung cancer who are surgical candidates. Tumor, normal tissue and blood specimens will be analyzed for changes in the immune system.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed in your information provided, side effects of non-ablative SBRT may include skin reactions at the treatment site, fatigue, shortness of breath, inflammation around normal lung tissue leading to coughing or pneumonia-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is in an early stage (Stage I or II).
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I am eligible for lung cancer surgery.
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My lung lesion is located in a place that can be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received immunotherapy before.
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I have had surgery on my lung or chest wall before.
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I have had radiation therapy to my chest before.
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I am currently taking drugs that suppress my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in tumor T cell repertoire following pre and post SBRT
Secondary study objectives
Impact of SBRT on post-surgical wound healing complication rate assessed by CTCAE v5
Loco-regional control disease
Metastasis-free survival
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
510 Previous Clinical Trials
176,873 Total Patients Enrolled
Shalina Gupta-Burt, MDPrincipal InvestigatorUniversity of Kansas Medical Center

Media Library

SBRT (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05094544 — N/A
Lung Cancer Research Study Groups: Non-ablative SBRT
Lung Cancer Clinical Trial 2023: SBRT Highlights & Side Effects. Trial Name: NCT05094544 — N/A
SBRT (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05094544 — N/A
~2 spots leftby Nov 2025
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