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Sacituzumab Tirumotecan + Pembrolizumab for Lung Cancer (TroFuse-007 Trial)

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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

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

Primary study objectives

Overall Survival (OS)

Secondary study objectives

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

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

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 3

~2810

0 / 3Eligibility criteria met