What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) like pembrolizumab, an immune checkpoint inhibitor targeting PD-1, are associated with several side effects. Pembrolizumab alone can cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. When combined with chemotherapy, additional side effects may include neutropenia, febrile neutropenia, and hypertension. Generally, severe treatment-related adverse effects are lower with pembrolizumab compared to chemotherapy alone.

What prior FDA approvals exist?

Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, has been FDA approved for the treatment of advanced NSCLC, particularly in patients with high PD-L1 expression (≥50%). It has shown improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy. Atezolizumab, targeting PD-L1, is also approved for front-line treatment of NSCLC with high PD-L1 expression, demonstrating improved OS over chemotherapy. Nivolumab, another PD-1 inhibitor, has been approved for previously treated advanced NSCLC, showing better OS compared to chemotherapy. These approvals highlight the efficacy of immune checkpoint inhibitors in improving outcomes for NSCLC patients.

What other types of research exist?

Promising alternatives to Pembrolizumab for NSCLC patients include Nivolumab (another PD-1 inhibitor), Atezolizumab (a PD-L1 inhibitor), and combination therapies such as Nivolumab with Ipilimumab (CTLA-4 inhibitor). These alternatives have shown efficacy in clinical trials and may offer different side effect profiles or enhanced outcomes.

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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

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new way to give the cancer drug pembrolizumab as an injection under the skin for people with advanced lung cancer. The goal is to see if this method works as well as the traditional IV method. The study will also check if it is safe and effective when used with standard chemotherapy.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

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

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

Primary study objectives

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 study objectives

Anti-Drug Antibodies (ADAs) Incidence After Administration of Pembrolizumab

Cycle 1 Maximum Concentration (Cmax) of Pembrolizumab

Cycle 1 Observed Ctrough of Pembrolizumab

+9 more

Awards & Highlights

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.

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

Nab-Paclitaxel

2014

Completed Phase 3

~4540

Carboplatin

2014

Completed Phase 3

~6120

Pemetrexed

2014

Completed Phase 3

~5550

Cisplatin

2013

Completed Phase 3

~3120

Paclitaxel

2011

Completed Phase 4

~5370

0 / 9Eligibility 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

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).