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Radiation Therapy

Image-Guided Radiation + Immunotherapy for Lung Cancer

N/A

Waitlist Available

Led By Michael Gensheimer

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0-2

Has at least one extracranial tumor safely treatable with radical-dose radiation therapy and that has not been previously treated with radiation

Must not have

Untreated brain metastases, if not planned to be treated in this course of radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies radiation therapy as a treatment for non-small cell lung cancer.

Who is the study for?

This trial is for adults over 18 with stage IV non-small cell lung cancer or those whose earlier-stage lung cancer has spread. They must have been on standard immunotherapy for at least four weeks, be stable in terms of symptoms and performance status, and show a certain response to treatment on recent scans. Pregnant women or those not using contraception are excluded.

What is being tested?

The study is testing high-dose image guided radiation therapy in patients with metastatic non-small cell lung cancer who are also undergoing immunotherapy. The goal is to see if this combination improves the body's response to the immunotherapy treatment.

What are the potential side effects?

While specific side effects aren't listed here, radiation therapy can generally cause fatigue, skin reactions at the treatment site, and may affect normal tissue function where it's applied. Immunotherapies can lead to immune-related inflammation in various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and perform daily activities.

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I have a tumor outside the brain that can be treated with high-dose radiation and hasn't been treated with radiation before.

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I am 18 years old or older.

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My lung cancer is at stage IV or was initially at an earlier stage but has now spread.

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I will be on immunotherapy for at least 3 more months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases that are not being treated in this radiation therapy course.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival

Secondary study objectives

Change in circulating tumor deoxyribonucleic acid levels as measured using CAncer Personalized Profiling by deep Sequencing

Change in immune marker levels as measured from peripheral blood using flow cytometry performed by the Human Immune Monitoring Core at Stanford University

Incidence of acute (0-6 months) and late (> 6 months) grade 3-5 toxicity

+1 more

Other study objectives

Patterns of response and progression

Progression free survival

Time to discontinuation of study immunotherapy agent

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immunotherapy plus Image-guided Radiation TherapyExperimental Treatment2 Interventions

Patients undergo radical-dose image guided radiation therapy daily for up to 10 days (within 2 weeks) while continuing their prior treatment with the treating physician's choice of regular medical care immunotherapy.

Group II: Immunotherapy Alone (Regular Medical Care)Active Control1 Intervention

Patients who decline to undergo radiation therapy will continue their prior treatment with the treating physician's choice of regular medical care immunotherapy.

0 / 6Eligibility criteria met