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Checkpoint Inhibitor

Immunotherapy + SBRT for Advanced Lung Cancer

Phase 3

Waitlist Available

Led By Michael Farris, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

Patients who are 18 years or older

Persistent active disease must be amenable to radiation treatment per the treating radiation oncologist, and patients must have at least one residual site of disease which can be identified by CT or PET/CT and targeted with radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is comparing immunotherapy with or without radiation therapy for stage IV non-small cell lung cancer.

Who is the study for?

This trial is for adults with stage IV non-small cell lung cancer that has spread and can be targeted by radiation. They must have had at least 4 cycles of systemic therapy without disease progression, be within 180 days from their first dose of this therapy, and have a performance status of 0-2. Pregnant women or those treated for other cancers (with some exceptions) in the last three years are excluded.Check my eligibility

What is being tested?

The study compares two approaches: one group receives immunotherapy with pembrolizumab plus stereotactic body radiation therapy (SBRT), while the other gets only pembrolizumab. SBRT delivers precise high-dose radiation to tumors over fewer sessions, potentially improving outcomes when combined with immunotherapy.See study design

What are the potential side effects?

Pembrolizumab may cause immune-related reactions affecting various organs, fatigue, skin issues, and flu-like symptoms. SBRT might lead to localized pain, swelling or scarring where the radiation is aimed; both treatments could also increase infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My remaining cancer can be targeted with radiation according to my radiation oncologist.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My lung cancer has spread to other parts of my body.

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I've completed 4 cycles of standard treatment without my cancer getting worse.

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I had early-stage lung cancer, treated it, but now have cancer in distant areas and have completed 4 cycles of treatment for this recurrence.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS) after completion of first line standard of care systemic therapy

Secondary outcome measures

Incidence of Adverse Events

Number of Participants with New Sites of Disease

Overall Survival

+2 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

79%

Cough

64%

Dyspnea

64%

Nausea

57%

Fatigue

43%

Constipation

36%

Pain

36%

Dizziness

29%

Anemia

29%

Back pain

29%

Vomiting

21%

Chest pain

21%

Anorexia

21%

Lymphocyte count decreased

21%

Death NOS

21%

Anxiety

21%

Fall

14%

Wheezing

14%

Dysphagia

14%

Hypotension

14%

Depression

14%

Diarrhea

14%

Platelet count decreased

14%

Abdominal Pain

14%

Edema

14%

Fever

14%

Headache

14%

Insomnia

14%

Palpitations

Alopecia

Dehydration

Blurred vision

Sinusitis

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Otitis externa

Creatinine increased

Dementia

Productive cough

Pneumonitis

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Hypernatremia

Eye pain

Hypertension

Tachycardia

Lung infection

Neuropathy

Pleuritic pain

Neutropenia

Hypoxia

Aspiration pneumonia

Blood bilirubin increased

Muscle weakness

Tremor

Weight loss

Thrombocytopenia

Floaters

Toothache

Esophagitis

Leukocytosis

Edema limbs

Gait disturbance

Parathesia (tingling)

Edema face

COPD

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Body Radiation Therapy

Maintenance Chemotherapy

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 Pembrolizumab OnlyExperimental Treatment1 Intervention

Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.

Group II: Arm 1 Stereotactic Body Radiation Therapy/PembrolizumabExperimental Treatment2 Interventions

3-10 treatments of SBRT/ pembrolizumab IV for 30 minutes every 3-4 weeks for 1 year at doctor's discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,241 Previous Clinical Trials

1,004,232 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,482 Total Patients Enrolled

Michael Farris, MDPrincipal InvestigatorWake Forest University Health Sciences

6 Previous Clinical Trials

197 Total Patients Enrolled

Media Library

Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03867175 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What types of cancer does Stereotactic Body Radiation Therapy commonly target?

"Stereotactic Body Radiation Therapy is a treatment that uses targeted radiation to kill cancer cells. It can be used on patients with unresectable melanoma, microsatellite instability high, and those who have progressed after chemotherapy."

Answered by AI

Are there many precedents for using Stereotactic Body Radiation Therapy in medical studies?

"Currently, there are 1000 clinical trials involving Stereotactic Body Radiation Therapy. 122 of those studies are in Phase 3 and 36021 locations around the world are running trials for this treatment."

Answered by AI

What is the goal of this research?

"The primary goal of this long-term clinical trial is to observe the progression-free survival rate of patients after they have completed first line systemic therapy. This will be followed by measuring the overall survival rate, which refers to the duration from when standard care systemic therapy begins until death or their last known contact. Additionally, researchers will document any adverse events throughout different treatments and calculate frequency/risk of these reactions according to where patients underwent treatment. Finally, investigators will assess disease progression in patients not receiving radiation at prior sites of infection before beginning chemotherapy"

Answered by AI

How many people will be included in this experiment?

"Yes, the information available on clinicaltrials.gov supports that this study is currently recruiting patients. The posting date was June 24th, 2019 and the most recent edit occurred on May 23rd, 2022. They are looking for 112 participants across 1 site."

Answered by AI

Are recruitment efforts for this research still underway?

"Yes, this is an ongoing clinical trial that has posted updated information on the website clinicaltrials.gov. The original posting was on 6/24/2019, and the most recent update was 5/23/2022. They are looking for 112 patients to participate at 1 site."

Answered by AI

How does Stereotactic Body Radiation Therapy affect a patient's long-term health?

"This therapy has been show to be effective in multiple Phase 3 trials, meaning that there is a significant amount of data supporting its efficacy and safety. As such, our team at Power has given it a score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Immunotherapy With or Without SBRT in Patients With Stage IV Non-small Cell Lung Cancer

2019. "Immunotherapy With or Without SBRT in Patients With Stage IV Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03867175.

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