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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 48 months
Awards & highlights
Study Summary
This trial compares pembrolizumab alone with pembrolizumab plus a different drug to see how well they work in treating metastatic non-small cell lung cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
My lung cancer is confirmed to be non-small cell type and has spread.
Select...
My cancer is not suitable for treatments targeting EGFR, ALK-1, or ROS-1.
Select...
My tumor shows a PD-L1 level of 50% or higher.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression-Free Survival (PFS)
Secondary outcome measures
Pain
Malignant Neoplasms
Dyspnea
+13 moreTrial 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
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
847,865 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,059,481 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,286 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a live vaccine in the last 30 days.I have been treated with specific immune therapy for cancer.My lung cancer is confirmed to be non-small cell type and has spread.I have had chemotherapy or targeted therapy for my advanced lung cancer.I am still recovering from major surgery or have complications.I have cancer that has spread to my brain or spinal cord.I have a heart condition.I have had hepatitis B or currently have hepatitis C.I have been treated with Topoisomerase 1 inhibitors or Trop-2 targeted therapy.I've had lung radiation over 30 Gray in the last 6 months.My heart's pumping ability is significantly reduced.I have an ongoing inflammatory bowel condition.I have a history of serious heart rhythm problems or have been on medication for arrhythmia.I have an autoimmune disease but haven't needed systemic treatment in the last 2 years.I have not had a heart attack or unstable chest pain in the last 6 months.I am currently on medication for an infection.You are expected to live for at least 3 more months.My cancer is not suitable for treatments targeting EGFR, ALK-1, or ROS-1.I have or had lung inflammation that needed steroids.I had radiotherapy less than 2 weeks ago or need steroids for radiation side effects.You have a strong allergic reaction (Grade 3 or higher) to pembrolizumab or sacituzumab govitecan, or any of the ingredients in these drugs.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.My tumor shows a PD-L1 level of 50% or higher.I have a history of HIV infection.I had another cancer but was treated successfully and have been cancer-free for 3 years.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current size of the cohort participating in this trial?
"Accurate. Information posted to clinicaltrials.gov confirms that this medical trial is currently recruiting patients, having first been uploaded on February 10th 2023 and more recently edited January 13th 2023. Approximately 614 participants must be found from a single site for the project to move forward."
Answered by AI
Has the combination of Pembrolizumab and Sacituzumab Govitecan been validated by the FDA?
"Pembrolizumab + Sacituzumab Govitecan is estimated to be of high safety, as evidenced by its 3 rating on our scale. The Phase 3 trial has generated data that both confirms efficacy and bolsters the drug's security profile."
Answered by AI
Are there any ongoing enrolment opportunities in this experiment?
"Affirmative. According to the data hosted on clinicaltrials.gov, this medical test is presently searching for participants and was first posted in February 10th 2021 while most recently updated on January 13th 2021. The project demands 614 patients from one location."
Answered by AI
What is the intended outcome of this experiment?
"The primary outcome for this clinical trial, which is expected to span up to 34 months, will be Overall Survival (OS). Secondary outcomes include Objective Response (OR) and Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), as well as Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30."
Answered by AI
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