What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) involving PD-1 inhibitors like pembrolizumab are associated with several side effects. Severe (≥grade 3) treatment-related adverse effects are lower with pembrolizumab compared to chemotherapy, occurring in about 27% of patients. Common side effects include pneumonitis (5.8% any-grade, 2.6% severe), skin reactions, and endocrine events. Other notable adverse effects include fatigue, diarrhea, and immune-related adverse events such as hepatitis and colitis. In combination therapies, additional side effects from chemotherapy, such as neutropenia and febrile neutropenia, may also occur.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has received FDA approval for the treatment of NSCLC in various settings. It is approved for use as monotherapy in patients with high PD-L1 expression (≥50%) and as part of combination therapy with chemotherapy for patients with metastatic NSCLC regardless of PD-L1 expression. Other similar PD-1/PD-L1 inhibitors approved for NSCLC include nivolumab and atezolizumab. Nivolumab is approved for previously treated advanced NSCLC, while atezolizumab is approved for first-line treatment in patients with high PD-L1 expression and for use in combination with chemotherapy in non-squamous NSCLC.

What other types of research exist?

Promising alternatives to MK-3475A (Pembrolizumab) for NSCLC patients include: 1) Nivolumab (PD-1 inhibitor) combined with Ipilimumab (CTLA-4 inhibitor), which has shown efficacy in first-line treatment of metastatic NSCLC. 2) Atezolizumab (PD-L1 inhibitor) combined with chemotherapy, which has demonstrated improved overall survival and progression-free survival in clinical trials. 3) Nivolumab combined with chemotherapy, which has shown increased progression-free survival in treatment-naïve patients with stage IIIB to IV nonsquamous NSCLC.

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PD-1 Inhibitor

SC Pembrolizumab + Hyaluronidase for Non-Small Cell 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 histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC).

Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated.

Must not have

Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.

Has an active infection requiring systemic therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to~60 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares two methods of administering a cancer drug in adults with advanced lung cancer. It aims to see if injecting the drug under the skin is as effective as giving it directly into a vein. The drug helps the immune system attack cancer cells by blocking a specific protein.

Who is the study for?

Adults with metastatic non-small cell lung cancer (NSCLC) who have not had previous systemic anticancer treatments for metastatic disease. Participants must have a life expectancy of at least 3 months and be able to provide a tumor tissue sample. They cannot join if they've had certain other cancers, immunodeficiency, major surgery complications, or active infections.

What is being tested?

The trial is testing the effectiveness of Pembrolizumab given subcutaneously (under the skin) coformulated with hyaluronidase versus intravenously (into a vein), alongside chemotherapy in first-line treatment for NSCLC. The main goal is to compare how the body processes both forms of Pembrolizumab.

What are the potential side effects?

Possible side effects include reactions at injection sites, fatigue, nausea from chemotherapy drugs like Paclitaxel and Cisplatin, lowered blood counts leading to increased infection risk or bleeding problems, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is confirmed as NSCLC through tests.

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I can provide a sample of my tumor that hasn't been treated with radiation.

Exclusion Criteria

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

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I have another cancer that is getting worse or was treated in the last 3 years.

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I am currently being treated for an infection.

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

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I have a history of HIV infection.

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I have received treatment for my advanced lung cancer.

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I have an immune system disorder or am on long-term steroids.

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I have been diagnosed with small cell lung cancer.

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I haven't had radiotherapy in the last 2 weeks or need steroids for radiation side effects.

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I have had lung radiation therapy of more than 30 Gray in the last 6 months.

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I have been treated for an autoimmune disease in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to~60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to~60 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose

Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State

Secondary study objectives

Area Under the Curve (AUC) of Pembrolizumab Measured at Steady State

Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score-Items 29 and 30

Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Physical Functioning Score-Items 1 to 5

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)Experimental Treatment8 Interventions

Participants with treatment-naïve metastatic NSCLC will receive MK 3475A SC in combination with platinum doublet chemotherapy.

Group II: Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)Active Control8 Interventions

Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Nab-paclitaxel

2014

Completed Phase 3

~1950

Filgrastim

2000

Completed Phase 3

~3690

Pemetrexed

2014

Completed Phase 3

~5550

Cisplatin

2013

Completed Phase 3

~3120

Carboplatin

2014

Completed Phase 3

~6120

0 / 12Eligibility criteria met

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

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors and chemotherapy. Pembrolizumab, a PD-1 inhibitor, works by blocking the programmed death-1 (PD-1) receptor on T-cells, preventing cancer cells from evading the immune system. This allows the immune system to recognize and attack cancer cells more effectively. Chemotherapy, often used in combination with PD-1 inhibitors, works by killing rapidly dividing cells, including cancer cells. These treatments are crucial for NSCLC patients as they can improve overall survival and progression-free survival by enhancing the body's ability to fight cancer and directly reducing tumor burden.

Efficacy and safety of pembrolizumab/carrelizumab, alone or in combination with chemotherapy in treatment of patients with non-small cell lung cancer: A protocol for evidence-based systematic review and Bayesian network meta-analysis.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).