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Alkylating agents
Pembrolizumab SC vs IV for Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has an ECOG performance score (PS) of 0 or 1
Has pathologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
Study Summary
This trial is testing a new way to give the drug pembrolizumab to see if it is as good as the standard way of giving it intravenously. It also is testing to see if it is safe and effective in people with squamous and nonsquamous non-small cell lung cancer.
Who is the study for?
This trial is for adults with Stage IV squamous or nonsquamous NSCLC who haven't had systemic treatment for metastatic disease. They must have good organ function, an ECOG score of 0 or 1, and agree to use contraception. Exclusions include severe drug hypersensitivity, recent investigational drug use, certain psychiatric disorders, active infections requiring therapy, specific lung conditions like pneumonitis, other active cancers within the last 3 years, known brain metastases unless treated under certain conditions, HIV/Hepatitis B/C infections.Check my eligibility
What is being tested?
The study tests pembrolizumab administered subcutaneously versus intravenously in combination with standard chemotherapy (Paclitaxel/Nab-Paclitaxel/Carboplatin/Cisplatin/Pemetrexed) as first-line treatment for metastatic NSCLC. It aims to compare the safety and effectiveness between the two methods of pembrolizumab administration.See study design
What are the potential side effects?
Possible side effects include reactions at injection site for SC method; infusion-related reactions for IV; fatigue; nausea; blood cell count changes leading to increased infection risk or bleeding problems; potential damage to organs from immune response activation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
I have been diagnosed with non-small cell lung cancer.
Select...
My lung cancer is at stage IV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab at Cycle 1
Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab
Secondary outcome measures
AUC 0-3wks of Pembrolizumab at Cycle 6
Anti-Drug Antibodies (ADAs) Incidence After Administration of Pembrolizumab
Cmax of Pembrolizumab at Cycle 6
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Pembrolizumab SC + Platinum Doublet ChemotherapyExperimental Treatment6 Interventions
Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous NSCLC.
Group II: Arm B: Pembrolizumab IV + Platinum Doublet ChemotherapyActive Control6 Interventions
Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous NSCLC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Nab-Paclitaxel
2014
Completed Phase 3
~4340
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Pemetrexed
2014
Completed Phase 3
~5250
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,040 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,291 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,949 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide a sample of my tumor for PD-L1 testing.You have a measurable disease according to specific medical assessment guidelines.My organs are functioning well.I have another cancer that is getting worse or was treated in the last 3 years.I've had lung radiation of more than 30 Gray in the last 6 months.I am fully active or can carry out light work.I am not pregnant or breastfeeding and either cannot become pregnant or agree to use birth control.I have been treated for an autoimmune disease in the last 2 years.I have not received a live vaccine in the last 30 days.I have or had lung inflammation that needed steroids.I am currently being treated for an infection.I have not had certain treatments or therapies before.I haven't had systemic treatment for my metastatic NSCLC, but past therapy ended over 12 months ago.I am a man willing to follow the study's contraception rules unless I am infertile.I have been diagnosed with non-small cell lung cancer.I have fluid buildup in my abdomen or chest that's stable after treatment.I have brain metastases or carcinomatous meningitis but meet specific conditions.I have a history of HIV, Hepatitis B, or active Hepatitis C.I have received an organ or tissue transplant from another person.Only participants with specific types of non-squamous tumors are allowed to participate.I will not need any cancer treatment other than the study's while participating.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.My non-squamous NSCLC does not need EGFR, ALK, or ROS1 therapy.My lung cancer is at stage IV.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy
- Group 2: Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current openings for participants in this trial?
"This study has concluded its recruitment drive. The posting date was August 5th, 2021 and the last edit was on November 6th, 2022. For those still seeking out clinical trials, there are 2095 active studies for patients with lung cancer and 2454 for Pembrolizumab SC."
Answered by AI
How many individuals have been approved to participate in this research?
"This study has already completed participant recruitment. The posting date was August 5th, 2021 and the last edit was on November 6th, 2022. However, there are 2095 other trials recruiting patients with lung cancer and 2454 for Pembrolizumab SC."
Answered by AI
Is this clinical trial taking place in numerous hospitals throughout Canada?
"Patients are able to enroll at 18 different locations, including Cancer Blood and Specialty Clinic (Site 0105) in Los Alamitos, California, St Joseph Heritage Healthcare-Oncology ( Site 0102) in Fullerton, Arkansas, and St. Bernards Medical Center ( Site 0103) in Jonesboro, Florida."
Answered by AI
Has Pembrolizumab SC been given the green light by the FDA?
"Pembrolizumab SC is safe, as evidenced by its Phase 3 status and the supportive data."
Answered by AI
For what purpose is Pembrolizumab SC most frequently prescribed?
"Pembrolizumab SC is used to treat aggressive skin cancers, recurrent cervical cancer, and certain types of B-cell lymphoma that have relapsed or are resistant to other treatments."
Answered by AI
Are there any other case studies that involve Pembrolizumab SC?
"Pembrolizumab SC was first researched in 1997 at City of Hope Comprehensive Cancer Center. As of now, there have been 2715 completed clinical trials and 2454 studies are still ongoing. A large concentration of these live studies are taking place in Los Alamitos, California."
Answered by AI
What are the aims of this trial?
"The aim of this trial is to assess the efficacy of pembrolizumab in terms of AUC 0-3wks at Cycle 1. Secondary outcomes being measured include number of participants experiencing an AE, overall survival, and observed Ctrough of pembrolizumab at end of Cycle 6."
Answered by AI
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