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Checkpoint Inhibitor

Pembrolizumab for Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by Joel Neal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function:
Chemotherapy administered in an every 2 week schedule must be completed ≥ 2 weeks prior to trial treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing how well pembrolizumab works against non-squamous non-small cell lung cancer that has spread to other parts of the body. Monoclonal antibodies might prevent tumor cells from growing and spreading.

Who is the study for?
This trial is for adults with non-squamous non-small cell lung cancer that has spread, who have had prior treatments but not anti-PD-1/L1 therapy. They should be in good health with a life expectancy of at least 3 months and no serious unresolved side effects from previous therapies. Women must test negative for pregnancy and agree to contraception; men also need to use birth control if their partner can bear children.Check my eligibility
What is being tested?
The study tests pembrolizumab, a monoclonal antibody designed to block tumor growth by interfering with specific pathways. It's given to patients whose tumors express PD-L1 on at least half of the cells and who haven't received systemic therapy for metastatic disease or have an EGFR mutation/ALK rearrangement after targeted therapy.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid dysfunction), infusion reactions, fatigue, appetite changes, diarrhea or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs are working well.
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I finished my chemotherapy at least 2 weeks ago.
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My cancer hasn't been treated before in its advanced stage, tests high for PD-L1, and lacks specific gene changes.
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I received radiation aimed at curing my cancer more than 3 weeks ago.
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I had targeted brain radiation at least a week ago.
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I am 18 years old or older.
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My liver enzymes are within acceptable limits.
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I received radiation for symptom relief more than a week ago.
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My brain cancer has been treated, is stable or not growing, and any tumors are small.
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I am not pregnant and agree to follow the study's birth control requirements or I am not of childbearing potential.
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I agree to use contraception or abstain from sex during and up to 120 days after the study.
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I finished my chemotherapy at least 3 weeks ago.
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I finished my monoclonal antibody therapy for cancer more than 3 weeks ago.
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I have had treatment for cancer that has spread.
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I have completed any prior radiation therapy before starting this trial.
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My kidney function, measured by creatinine or clearance, is within the required range.
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I finished my targeted therapy at least a week ago.
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My lung cancer has returned or spread and is not squamous.
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I have had targeted therapy for my cancer due to an EGFR mutation or ALK rearrangement.
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I had whole brain radiation more than 2 weeks ago.
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I finished my chemotherapy at least a week ago.
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I am fully active or can carry out light work.
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I am willing and able to have a needle biopsy of my tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
ctDNA levels measured using CAPP-Seq
Secondary outcome measures
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events version 4.03
Overal Response Rate (ORR)
Overall Survival (OS)
+1 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%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab)Experimental Treatment1 Intervention
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
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?

Joel NealLead Sponsor
3 Previous Clinical Trials
81 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,546 Total Patients Enrolled

Frequently Asked Questions

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

Is this the only clinical trial that has been done using Pembrolizumab?

"Pembrolizumab is being researched in over 1000 ongoing studies, 122 of which are in the third and final phase. The majority of these investigations are taking place in Houston, Texas; however, there are 36053 locations worldwide running clinical trials for this immunotherapy treatment."

Answered by AI

Across how many people is this experiment being conducted?

"Unfortunately, this particular clinical trial is no longer enlisting patients. This study was first posted on October 1st, 2016 and experienced its most recent update on December 21st, 2021. There are currently 1393 other trials for carcinoma, non-small-cell lung cancer and 1000 Pembrolizumab studies that are actively searching for participants."

Answered by AI

Is it generally well-tolerated for patients to take Pembrolizumab?

"While there are no Phase 2 trials supporting pembrolizumab's efficacy, there is some data backing its safety which gives it a score of 2."

Answered by AI

Are new participants being accepted for this experiment at this time?

"This particular study is not recruiting patients at the moment, as per the most recent information available on clinicaltrials.gov. This trial was first posted on October 1st, 2016 and last updated December 21st, 2021. There are 2393 other trials which are currently open for recruitment."

Answered by AI

What are the most frequent reasons that patients receive Pembrolizumab?

"While malignant neoplasms is the primary condition Pembrolizumab treats, this medication can also be used to manage unresectable melanoma, microsatellite instability high, and chemotherapy-resistant cancer."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer
Joel Neal 2016. "Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02955758.
~3 spots leftby Apr 2025
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