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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
Must not have
Patients with major activating mutations in EGFR (del19, L858R, and T790M) or ROS 1 or ALK gene rearrangements are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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.
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer does not have major EGFR mutations or ROS1/ALK rearrangements.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS) after completion of first line standard of care systemic therapy
Secondary study objectives
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
87%
Fatigue
53%
Nausea
33%
Cough
27%
Pain
27%
Fall
27%
Dyspnea
27%
Depression
27%
Lymphocyte count decreased
27%
Platelet count decreased
27%
Anemia
20%
Chills
20%
Dizziness
20%
Edema limbs
20%
Chest pain
20%
Neutropenia
20%
Diarrhea
13%
Edema
13%
Dysesthesia
13%
Dysgeusia
13%
Insomnia
13%
Constipation
13%
Delirium
13%
Skin infection
13%
Vomiting
13%
Tinnitus
13%
Myalgia
13%
Rash
13%
Back pain
13%
Weakness (limb)
13%
Weight loss
7%
Proteinuria
7%
Bruising
7%
Hearing loss
7%
Anxiety
7%
Headaches
7%
Oral lesions
7%
Weakness (facial)
7%
Neutrophil count decreased
7%
Acute kidney injury
7%
Hypokalemia
7%
Lymphocytopenia
7%
Seizures
7%
Hearing impaired
7%
Hypernatremia
7%
Creatinine increased
7%
Headache
7%
Death NOS
7%
Gait disturbance
7%
Nasal congestion
7%
Fever
7%
Tremor
7%
Urinary urgency
7%
Hypoxic respiratory failure
7%
Amnesia
7%
Photophobia
7%
Pleural effusion
7%
Urinary frequency
7%
Dysphagia
7%
Low white blood count
7%
Sneezing
7%
Cognitive disturbance
7%
Muscle weakness
7%
Erythema multitforme
7%
Lung infection
7%
Hypertension
7%
Allergy (seasonal)
7%
Hypomagnesemia
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Anorexia
7%
Sleep apnea
7%
Encephalopathy
7%
Hypoxia
7%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~790
Pembrolizumab
2017
Completed Phase 3
~2810

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,392 Previous Clinical Trials
2,451,901 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,012,139 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
~2 spots leftby Jul 2027
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