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Pembrolizumab + Sacituzumab tirumotecan 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

Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC

Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) 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 is comparing a combination of MK-2870 and pembrolizumab to just pembrolizumab alone to see which one is better for overall survival. Participants who have completed the

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) showing high PD-L1 expression in tumors. Candidates must have a life expectancy of over 3 months, controlled HIV if present, and no need for EGFR-, ALK-, or ROS1-targeted primary therapy. They should be physically able to perform daily activities with little or no assistance.Check my eligibility

What is being tested?

The study aims to see if MK-2870 combined with pembrolizumab improves survival compared to using pembrolizumab alone in patients. Participants who show disease progression after initial treatment may receive additional cycles of pembrolizumab monotherapy.See study design

What are the potential side effects?

While specific side effects are not listed here, both MK-2870 and Pembrolizumab can cause immune-related reactions affecting various organs, infusion-related symptoms, fatigue, skin issues, hormonal changes and increased risk of infections.

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 by lab tests.

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My cancer is not suitable for EGFR, ALK, or ROS1-targeted treatments.

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My tumor shows high PD-L1 expression.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Change From Baseline in Chest Pain (EORTC QLQ-LC13 item 40) Score

Change From Baseline in Cough (EORTC QLQ-LC13 Item 31) Score

Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + Sacituzumab tirumotecanExperimental Treatment2 Interventions

Participants receive sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle + 400 mg Pembrolizumab every 6 weeks (q6w) via IV infusion on Day 1 of each 6-week cycle for 18 cycles. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.

Group II: PembrolizumabActive Control1 Intervention

Participants receive 400 mg Pembrolizumab via IV infusion q6w on Day 1 of each 6-week cycle for 18 cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,060,532 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,790 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the level of safety associated with the combination therapy involving MK-2870 and Pembrolizumab for individuals?

"Based on the fact that this trial is classified as Phase 3, which indicates the presence of both efficacy and safety data from multiple rounds, our team at Power rates the safety of MK-2870 + Pembrolizumab as a 3 on a scale of 1 to 3."

Answered by AI

Are potential participants currently able to apply for enrollment in this study?

"Indeed, as indicated on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible patients. The trial was initially posted for recruitment on December 15th, 2023 and its most recent update occurred on January 4th, 2024. The study aims to enroll a total of 614 participants across four designated sites."

Answered by AI

Are there numerous healthcare facilities conducting this medical study within the country of Canada?

"Among the available sites for this clinical trial are Westmead Hospital-Department of Medical Oncology (Site 3000) located in Westmead, Hacettepe Universite Hastaneleri-oncology hospital (Site 2501) situated in Ankara, and Hattiesburg Clinic Hematology/Oncology (Site 0104) based in Hattiesburg. Additionally, there are four other locations where patients can participate in the study."

Answered by AI

What is the current number of participants involved in this clinical investigation?

"To successfully carry out this study, a total of 614 participants who meet the eligibility criteria are needed. The trial will be conducted by Merck Sharp & Dohme LLC at various locations, including Westmead Hospital-Department of Medical Oncology (Site 3000) in Westmead, New South Wales and Hacettepe Universite Hastaneleri-oncology hospital (Site 2501) in Ankara, Mississippi."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

2023. "Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06170788.

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