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Pembrolizumab Monotherapy versus Sacituzumab Govitecan in Combination with MK‑3475 for PD-L1 TPS ≥50% Metastatic NSCLC
EU CTIS ID: 2023-503501-11-00
What this study is testing
1. To compare pembrolizumab in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival per RECIST 1.1 as assessed by blinded independent central review 2. To compare pembrolizumab in combination with sacituzumab govitecan with pembrolizumab alone with respect to overall survival
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Has provided tumor tissue that demonstrates PD-L1 tumor proportion score (TPS) ≥50% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
- Has a life expectancy of at least 3 months
You likely can't join if
- Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
- Has active chronic inflammatory bowel disease
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab or sacituzumab govitecan and/or any of their excipients
- Has active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy
See the full eligibility criteria
- 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
- Has provided tumor tissue that demonstrates PD-L1 tumor proportion score (TPS) ≥50% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
- Has a life expectancy of at least 3 months
- Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
- Has active chronic inflammatory bowel disease
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab or sacituzumab govitecan and/or any of their excipients
- Has active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has history of human immunodeficiency virus (HIV) infection
- History of hepatitis B or known active hepatitis C virus infection
- Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
- Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC
- Have not adequately recovered from major surgery or have ongoing surgical complications
- Has previously received treatment with Topoisomerase 1 inhibitors or Trop-2 targeted therapy
- 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 received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicities requiring corticosteroids
- Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
- Has cardiac disease * Myocardial infarction or unstable angina pectoris within 6 months of enrollment * History of serious ventricular arrhythmia, high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications; history of QT interval prolongation * New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of <40%
The study team makes the final eligibility decision.
Where it's taking place
- China
- Korea, Republic of
- United States
- Mexico
- Australia
- Canada
- Philippines
- Taiwan
- Chile
- United Kingdom
- Malaysia
- Brazil
- Japan
- Peru
- Thailand
- Israel
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Korea, Republic of; United States; Mexico; Australia; Canada and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.