What side effects are associated with this type of intervention?

Pembrolizumab, a PD-1 inhibitor, is commonly associated with side effects such as fatigue, nausea, and increased liver function tests. Severe treatment-related adverse effects include pneumonitis, with any-grade pneumonitis reported in 5.8% of patients and severe pneumonitis in 2.6%. Sacituzumab Govitecan, an antibody-drug conjugate targeting Trop-2, can cause side effects like neutropenia, diarrhea, nausea, and fatigue. Both treatments have shown efficacy in NSCLC but require careful monitoring for these adverse effects.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been FDA-approved for the treatment of NSCLC, particularly in patients with high PD-L1 expression. It has shown significant improvements in overall survival and progression-free survival when combined with chemotherapy, as demonstrated in trials like KEYNOTE-407. Other similar PD-1/PD-L1 inhibitors approved for NSCLC include nivolumab and atezolizumab. Sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2, is being studied in combination with pembrolizumab, but its use in NSCLC is still investigational. The combination aims to leverage the immune checkpoint blockade of pembrolizumab with the targeted cytotoxic effects of sacituzumab govitecan.

What other types of research exist?

Promising novel alternatives for NSCLC patients in 2024 include: 1) Atezolizumab (PD-L1 inhibitor), which has shown efficacy in various trials for NSCLC. 2) Nivolumab (PD-1 inhibitor), another immune checkpoint inhibitor with proven benefits in NSCLC. 3) Enfortumab Vedotin, an antibody-drug conjugate targeting Nectin-4, which has shown promise in urothelial carcinoma and is being explored for other cancers. 4) Amivantamab, a bispecific antibody targeting EGFR and MET, which has shown activity in NSCLC with specific mutations. These alternatives offer different mechanisms of action and have demonstrated potential in clinical settings.

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PD-L1 Inhibitor

Pembrolizumab vs. Pembrolizumab + Sacituzumab Govitecan for Non-Small Cell Lung Cancer

Phase 3

Recruiting

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 a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)

Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase 1 (ALK-1), or ROS proto-oncogene 1 (ROS-1)-directed therapy is not indicated as primary therapy

Must not have

Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 48 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares pembrolizumab alone and in combination with sacituzumab govitecan in adults with advanced lung cancer who have high levels of a certain protein. Pembrolizumab boosts the immune system to fight cancer, while sacituzumab govitecan targets and kills cancer cells. Pembrolizumab has been used as a standard treatment for a type of lung cancer, showing improved survival rates compared to other treatments.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer showing high levels of PD-L1. Participants must not have had previous cancer treatments, have a life expectancy over 3 months, and cannot be eligible for EGFR or ALK-1 targeted therapy. They should not have serious heart conditions, active infections, certain viral hepatitis histories, recent vaccinations with live viruses, autoimmune diseases needing treatment in the last 2 years, or severe allergies to the drugs being tested.

What is being tested?

The study compares two approaches: one group receives Pembrolizumab alone while another gets a combination of Pembrolizumab and Sacituzumab Govitecan. The main focus is on how long patients live without their disease getting worse (PFS) and overall survival (OS), assessed by independent reviewers using standard criteria.

What are the potential side effects?

Possible side effects include allergic reactions to medication components, immune system-related inflammation affecting various organs including lungs (pneumonitis), fatigue, digestive issues like diarrhea or constipation from chemotherapy agents used in Sacituzumab Govitecan.

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 to be non-small cell type and has spread.

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My cancer is not suitable for treatments targeting EGFR, ALK-1, or ROS-1.

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My tumor shows a PD-L1 level of 50% or higher.

Exclusion Criteria

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

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I have been treated with specific immune therapy for cancer.

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I have cancer that has spread to my brain or spinal cord.

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I have had chemotherapy or targeted therapy for my advanced lung cancer.

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I have a heart condition.

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I have had hepatitis B or currently have hepatitis C.

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I have been treated with Topoisomerase 1 inhibitors or Trop-2 targeted therapy.

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My heart's pumping ability is significantly reduced.

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I have an ongoing inflammatory bowel condition.

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I have a history of serious heart rhythm problems or have been on medication for arrhythmia.

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I have an autoimmune disease but haven't needed systemic treatment in the last 2 years.

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I am currently on medication for an infection.

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I have or had lung inflammation that needed steroids.

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I had radiotherapy less than 2 weeks ago or need steroids for radiation side effects.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

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I have a history of HIV infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 48 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

Overall Survival (OS)

Progression-Free Survival (PFS)

Secondary study objectives

Pain

Malignant Neoplasms

Dyspnea

+13 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

Group I: Pembrolizumab + Sacituzumab GovitecanExperimental Treatment2 Interventions

Participants receive sacituzumab govitecan 10mg/kg intravenous (IV) infusion once weekly on Day 1 and Day 8 of a continuous 21-day cycle until progressive disease (PD) requiring discontinuation, unacceptable toxicity, withdrawal of consent, or death. Participants receive pembrolizumab 200mg IV infusion on Day 1 every 3 weeks (Q3W) for up to 35 cycles (each cycle length = 21 days).

Group II: PembrolizumabExperimental Treatment1 Intervention

Participants receive pembrolizumab 200mg IV infusion on Day 1 Q3W for up to 35 cycles (each cycle length = 21 days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab Govitecan

2019

Completed Early Phase 1

~30

Pembrolizumab

2017

Completed Phase 3

~2810

0 / 18Eligibility 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

Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 pathway, enabling the immune system to recognize and attack cancer cells. Sacituzumab Govitecan, an antibody-drug conjugate, targets the Trop-2 protein on cancer cells, delivering a cytotoxic agent directly to them. These targeted therapies are significant for NSCLC patients as they offer more personalized and potentially more effective treatment options with fewer side effects compared to traditional chemotherapy.