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Pembrolizumab for Early-Stage Non-Small Cell Lung Cancer

Phase 2
Recruiting
Research Sponsored by Greg Durm, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have undergone complete surgical resection of their stage I NSCLC between 4-12 weeks prior to registration and have negative surgical margins (R0). NOTE: Both squamous and non-squamous histologies are allowed into the study. Cancers with a histology of 'adenosquamous' are considered a type of adenocarcinoma and thus 'non-squamous histology'. NOTE: Staging will be according to the AJCC 8th edition. Pathological tumor size must be 1.0 - 4.0 cm in greatest dimension. NOTE: According to AJCC 8th edition, subjects with lepidic predominant adenocarcinoma should be staged based on their invasive tumor size and not their total tumor size (i.e., subjects with lepidic predominant tumors whose invasive tumor size is less than 1 cm are not eligible, even if their total tumor size is 1.0 cm or greater). Surgery for this lung cancer must be completed at least 28 days prior to registration. Must have either previous NGS and PD-L1 results available using the Dako 22C3 antibody or have archival tissue of surgical specimen from current diagnosis available to perform analyses. If prior PD-L1 results with Dako 22C3 antibody are not available from a CLIA-accredited laboratory, subjects must be able to provide 5 x 5µm unstained slides for prospective analysis to be used for stratification. If NGS results are not available, subjects must be able to provide at least 10 x 10µm unstained and 1 x 4µm H&E slides from current diagnosis for future NGS and/or other genetic analyses. Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
Males and females age ≥ 18 years at the time of consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years from time of randomization
Awards & highlights

Study Summary

This trial is testing whether the addition of the immunotherapy drug, Pembrolizumab, to standard of care following surgery for stage I NSCLC, will improve outcomes.

Who is the study for?
Adults over 18 who've had surgery to remove stage I NSCLC with tumors between 1-4 cm and are in good health can join. They must not be pregnant, breastfeeding, or planning to conceive soon. People with certain genetic mutations, previous cancer treatments, active infections like TB or hepatitis, other cancers within the last 3 years, severe allergies to pembrolizumab ingredients, recent live vaccines, autoimmune diseases needing treatment in the past two years or organ transplants cannot participate.Check my eligibility
What is being tested?
The trial is testing if Pembrolizumab given every six weeks for nine cycles improves outcomes compared to just watching after surgery for lung cancer. Patients will be randomly assigned to either get the drug or go into observation. The groups are divided based on PD-L1 protein levels and tumor size.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects such as inflammation of organs (like lungs causing pneumonitis), skin reactions, hormone gland problems (like thyroid issues), infusion reactions during administration of the drug and could potentially worsen pre-existing autoimmune diseases.

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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I am not pregnant or breastfeeding, and if of childbearing age, I use effective birth control or practice abstinence.
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I have been mostly active and able to carry on all pre-disease activities without restriction in the last 28 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years from time of randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from time of randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Free Survival (DFS)
Secondary outcome measures
1 Year Disease Free Survival Rate
1 Year Overall Survival Rate
2 Year Disease Free Survival Rate
+5 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A- PembrolizumabExperimental Treatment1 Intervention
Pembrolizumab 400mg IV every 6 weeks x 9 cycles
Group II: Arm B - ObservationActive Control1 Intervention
Observation only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,869 Previous Clinical Trials
5,051,665 Total Patients Enrolled
Greg Durm, MDLead Sponsor
3 Previous Clinical Trials
147 Total Patients Enrolled

Media Library

Pembrolizumab Clinical Trial Eligibility Overview. Trial Name: NCT04317534 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm B - Observation, Arm A- Pembrolizumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04317534 — Phase 2
Pembrolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04317534 — Phase 2

Frequently Asked Questions

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

Are patients currently being recruited for this trial?

"That is correct. As of 8/9/2022, the clinical study was still recruiting patients which it will continue to do so at 11 different locations until a total of 368 people have participated."

Answered by AI

How many individuals have signed up to participate in this research project?

"To run this experiment, the sponsor needs 368 participants that fit the inclusion criteria. Merck Sharp & Dohme LLC will carry out the trial at various locations, for example University of Nebraska Medical Center in Omaha and Indiana University Melvin and Bren Simon Cancer Center in Indianapolis."

Answered by AI

In how many different areas is this trial being conducted?

"There are 11 locations in total where this trial is currently accepting patients. A few of these sites include University of Nebraska Medical Center, Indiana University Melvin and Bren Simon Cancer Center, as well as Penn State Cancer Institute."

Answered by AI

Could you please share if Pembrolizumab has been studied before in other clinical trials?

"Pembrolizumab was first trialled a decade ago, at City of Hope. There are now 250 completed studies on this medication, with 1000 more currently underway across the globe. Many of these active trials are based in Omaha, Nebraska."

Answered by AI

What are some of the more popular indications for Pembrolizumab?

"Pembrolizumab has shown to be an effective treatment for malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

What is the FDA's current stance on Pembrolizumab?

"Given that this is a Phase 2 trial - meaning there is some data supporting safety but not efficacy - our team at Power have given Pembrolizumab a score of 2 for safety."

Answered by AI
~50 spots leftby Apr 2025