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PD-1 Inhibitor

SBRT + Pembrolizumab for Lung Cancer

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC by chest computed tomography (CT) and positron emission tomography (PET) scan
Has a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 1 year
Awards & highlights

Study Summary

This trial is studying how well SBRT plus pembrolizumab (MK-3475) works in treating patients with unresected stage I or II non-small cell lung cancer.

Who is the study for?
Adults with untreated Stage I or II non-small cell lung cancer (NSCLC) who can't have surgery, are eligible for SBRT, and have good organ function. Participants must agree to contraception if of childbearing potential. Exclusions include active infections, HIV, prior immunotherapy treatments, recent live vaccines, certain autoimmune diseases, pregnancy/breastfeeding, and a history of other cancers within 3 years.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of combining Stereotactic Body Radiotherapy (SBRT) with Pembrolizumab versus SBRT with a placebo in treating NSCLC. It aims to see if adding Pembrolizumab improves event-free survival (EFS) and overall survival (OS).See study design
What are the potential side effects?
Possible side effects from Pembrolizumab may include immune system reactions affecting organs, fatigue, skin issues like rash or itchiness; infusion-related reactions; hormonal gland problems; liver inflammation; digestive tract symptoms such as nausea and diarrhea.

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 the early stages and has not been treated yet.
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I can take care of myself and am up and about more than half of my waking hours.
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I can undergo SBRT and my tumor is not in the very center of my chest.
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I can't have chest surgery due to other health issues, or I chose radiotherapy over surgery.
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I do not have more than 2 cancer nodules, or signs of cancer invading my heart lining or causing diaphragm issues.
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My organs are functioning well enough for treatment.
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I am not pregnant or breastfeeding and either cannot become pregnant or am using effective birth control.
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I am a male agreeing to not donate sperm and either remain abstinent or use contraception for 90 days post-treatment.
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My radiation therapy plan is approved by a quality assurance group.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free Survival (EFS)
Secondary outcome measures
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score
Dyspnea
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Score
+6 more

Side effects data

From 2022 Phase 3 trial • 27 Patients • NCT01926197
100%
Fatigue
100%
Aspartate aminotransferase increased
92%
Diarrhea
92%
Platelet count decreased
83%
Anemia
83%
Weight loss
83%
Alkaline phosphatase increased
83%
Nausea
75%
Pain, abdominal
67%
Decreased appetite (anorexia)
67%
Hypertension
58%
Hyperglycemia
58%
Nerve damage or injury (neuropathy)
58%
Hypokalemia
50%
Alanine aminotransferase increased
50%
White blood cell decreased
50%
Hypoalbuminemia
42%
White blood cell (WBC) count elevated (leukocytosis)
42%
Lymphocyte count decreased
33%
Edema, peripheral
33%
Bloating
25%
Vomiting
25%
Bad taste in mouth (dysgeusia)
25%
Hyponatremia
25%
Anxiety
25%
Pain
25%
Constipation
25%
Hypocalcemia
25%
Labored breathing (dyspnea)
17%
Muscle pain (myalgia)
17%
Indigestion (dyspepsia)
17%
Pain, back
17%
Flatulence
17%
General feeling of discomfort (malaise)
17%
Depression
17%
Hair loss, immune-realted (alopecia)
17%
Neutrophil count decreased
17%
Difficulty sleeping (insomnia)
17%
Oral inflammation (mucositis)
8%
Hearing impaired
8%
Abdominal distention
8%
Abnormal sensation in the mouth (oral dysesthesia)
8%
Dry mouth
8%
Gastroesophageal reflux disease
8%
Pain, stomach
8%
Chills
8%
Edema, localized
8%
Pain, chest, non-cardiac
8%
Lymphocyte count increased
8%
Other, Neutrophil count increase
8%
Other, Protein total decrease
8%
Thrombocytopenia
8%
Weight gain
8%
Hypercalcemia
8%
Hypernatremia
8%
Muscle weakness lower limb
8%
Dizziness
8%
Drowsiness, unusual (somnolence)
8%
Nerve tingling (paresthesia)
8%
Slow or slurred speech (dysarthria)
8%
Tiredness (fatigue)
8%
Tremor
8%
Rash
8%
Lymphedema
8%
Thromboembolic event
8%
Gastroparesis
8%
Fever
8%
Flu-like symptoms
8%
Allergic reaction
8%
Alkaline phosphatase decreased
8%
Blood bilirubin increased
8%
Dehydration
8%
Pain, flank
8%
Nerve damage or injury (neuropathy), peripheral sensory
8%
Confusion
8%
Other, axilla boil
8%
Other, Creatinine decreased
8%
Other, hemoglobin decreased
8%
Bleed (hemorrhage), gastrointestinal
8%
Infusion-related reaction
8%
Arthritis
8%
Generalized muscle weakness
8%
Memory impairment
8%
Movements involuntary
8%
Chronic kidney disease
8%
Cataract
8%
Other, excess in the stool (steatorrhea)
8%
Other, stool discolored, clay color
8%
Gamma-glutamyl transferase (GGT) increased
8%
Hypoglycemia
8%
Urinary incontinence
8%
Urinary urgency
8%
Urine discoloration
8%
Excessive sweating (hyperhidrosis)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Modified FOLFIRINOX
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SBRT+PembolizumabExperimental Treatment2 Interventions
Participants receive SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray [Gy] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle is 21 days.
Group II: SBRT+PlaceboPlacebo Group2 Interventions
Participants receive SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle is 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy (SBRT)
2016
Completed Phase 3
~580
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,475 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,049,264 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,061,764 Total Patients Enrolled

Media Library

Non-Small Cell Lung Cancer Research Study Groups: SBRT+Pembolizumab, SBRT+Placebo

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 Radiotherapy (SBRT) target most often?

"SBRT is a type of radiotherapy used to target malignant neoplasms. However, it has also been used to treat other conditions such as unresectable melanoma and microsatellite instability high."

Answered by AI

Are researchers currently recruiting participants for this trial?

"The study is recruiting patients, as advertised on clinicaltrials.gov. This particular trial was first posted on June 25th, 2019 and has had its information updated as recently as October 12th, 2020."

Answered by AI

What are the effects that researchers are hoping to see from this clinical trial?

"The primary outcome of this long-term trial (68 months) will be Event-free Survival (EFS), which will be monitored closely. Additionally, the study will secondary objectives including changes in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score, Time to Death or Distant Metastases (TTDM), and Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of"

Answered by AI

How many participants are allowed in this clinical trial?

"In order to complete this clinical trial, 530 willing and eligible patients are required. Those that meet the specified inclusion criteria can choose to participate at sites like Sault Area Hospital (Site 0101) in Sault Ste Marie, Ontario and Lankenau Medical Center (Site 3041) in Wynnewood, Pennsylvania."

Answered by AI

Has the FDA sanctioned Stereotactic Body Radiotherapy (SBRT) for use?

"There is some evidence from past clinical trials to support the efficacy of SBRT, and it has received multiple rounds of support for its safety, so our team at Power has given it a 3."

Answered by AI

Are there any other examples in which Stereotactic Body Radiotherapy (SBRT) has been used?

"SBRT was first trialled a decade ago, at City of Hope. Since then, there have been 18,486 completed studies on the topic. At the moment, there are 999 ongoing studies, with many of them taking place in Sault Ste Marie, Ontario."

Answered by AI

Could you inform me as to how many different hospitals are running this experiment?

"Sault Area Hospital (Site 0101), Lankenau Medical Center (Site 3041), Trillium Health Partners - Credit Valley Hospital (Site 0102), and 31 other locations are participating in this trial."

Answered by AI
~76 spots leftby Apr 2025