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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

Must not have

Has had an allogenic tissue/solid organ transplant

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 year

Awards & highlights

Pivotal Trial

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.

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).

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 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 radiation therapy plan is approved by a quality assurance group.

Exclusion Criteria

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

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I have received an organ or tissue transplant from another person.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have been treated with specific immune system targeting drugs before.

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I have an active tuberculosis infection.

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I have had pneumonitis treated with steroids or have it now.

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I have not received a live vaccine in the last 30 days.

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I am currently being treated for an infection.

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I have an autoimmune disease treated in the last 2 years, except for hormone replacement.

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I have a history of Hepatitis B or an active Hepatitis C infection.

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I have had radiation therapy to my chest area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 1 year

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

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

Primary study objectives

Event-free Survival (EFS)

Secondary study objectives

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%

Bloating

33%

Edema, peripheral

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)

Chills

Fever

Allergic reaction

Bleed (hemorrhage), gastrointestinal

Hearing impaired

Edema, localized

Other, Creatinine decreased

Pain, flank

Muscle weakness lower limb

Drowsiness, unusual (somnolence)

Tiredness (fatigue)

Lymphedema

Thromboembolic event

Abdominal distention

Abnormal sensation in the mouth (oral dysesthesia)

Dry mouth

Gastroesophageal reflux disease

Pain, stomach

Pain, chest, non-cardiac

Lymphocyte count increased

Other, Neutrophil count increase

Other, Protein total decrease

Thrombocytopenia

Weight gain

Hypercalcemia

Hypernatremia

Dizziness

Nerve tingling (paresthesia)

Slow or slurred speech (dysarthria)

Tremor

Rash

Gastroparesis

Flu-like symptoms

Alkaline phosphatase decreased

Blood bilirubin increased

Dehydration

Nerve damage or injury (neuropathy), peripheral sensory

Confusion

Other, axilla boil

Other, hemoglobin decreased

Infusion-related reaction

Arthritis

Generalized muscle weakness

Memory impairment

Movements involuntary

Chronic kidney disease

Cataract

Other, excess in the stool (steatorrhea)

Other, stool discolored, clay color

Gamma-glutamyl transferase (GGT) increased

Hypoglycemia

Urinary incontinence

Urinary urgency

Urine discoloration

Excessive sweating (hyperhidrosis)

100%

80%

60%

40%

20%

Study treatment Arm

Modified FOLFIRINOX

Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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)

2017

Completed Phase 3

~550

Pembrolizumab

2017

Completed Phase 3

~2810