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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)
Must not have
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights

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 below
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I am fully active or can carry out light work.
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I have been diagnosed with non-small cell lung cancer.
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My lung cancer is at stage IV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated for an autoimmune disease in the last 2 years.
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I have or had lung inflammation that needed steroids.
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I am currently being treated for an infection.
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I have a history of HIV, Hepatitis B, or active Hepatitis C.
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I have received an organ or tissue transplant from another person.
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I will not need any cancer treatment other than the study's while participating.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 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
Cycle 1 Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab
Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab
Secondary outcome measures
Anti-Drug Antibodies (ADAs) Incidence After Administration of Pembrolizumab
Cycle 1 Maximum Concentration (Cmax) of Pembrolizumab
Cycle 1 Observed Ctrough of Pembrolizumab
+9 more

Trial 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 non-small cell lung cancer (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 non-small cell lung cancer (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
~4410
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Pemetrexed
2014
Completed Phase 3
~5250

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Immune checkpoint inhibitors, such as Pembrolizumab, target the PD-1 pathway, which plays a crucial role in downregulating the immune system. By blocking PD-1, these inhibitors prevent cancer cells from evading immune detection, thereby enhancing the body's ability to attack and destroy tumor cells. This mechanism is particularly important for NSCLC patients as it offers a targeted approach to treatment, potentially leading to improved survival rates and better management of the disease compared to traditional chemotherapy. The efficacy of these treatments in various clinical trials underscores their significance in the evolving landscape of NSCLC therapy.
Efficacy and Safety of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC: a Randomized, Double-Blind, Phase 3 Study (Oncology pRogram by InnovENT anti-PD-1-11).

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,919 Previous Clinical Trials
5,067,732 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,481 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,801 Previous Clinical Trials
8,069,799 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04956692 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy, Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04956692 — Phase 3
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04956692 — Phase 3
~136 spots leftby Jul 2025