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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~ 118 months

Awards & highlights

Study Summary

This trial aims to see if combining MK-2870 with pembrolizumab after surgery can effectively treat non-small cell lung cancer (NSCLC) in patients who did not have a complete

Who is the study for?

This trial is for adults with a type of lung cancer called NSCLC who haven't fully responded to surgery. Participants should not have achieved complete removal of cancer (pCR). They must be healthy enough for further treatment.Check my eligibility

What is being tested?

The study tests if MK-2870 combined with pembrolizumab improves disease-free survival compared to using pembrolizumab alone after surgery in NSCLC patients without pCR. It's a comparison between two potential post-surgery treatments.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, fatigue, nausea, and increased risk of infections from pembrolizumab. MK-2870 may add more risks but specifics are not provided.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~ 118 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~ 118 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~ 118 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

Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)

Secondary outcome measures

Change from Baseline in Chest pain scores (QLQ-LC24 Item 40)

Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52)

Change from Baseline in Dyspnea scores (QLQ-C30 Item 8)

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + Sacituzumab tirumotecanExperimental Treatment2 Interventions

Participants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 20 doses (~40 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (~42 weeks).

Group II: PembrolizumabActive Control6 Interventions

Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (~42 weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,060,362 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,624 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 overall safety profile of MK-2870 in combination with 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

What is the current number of participants being enrolled in this research investigation?

"Affirmative. Details provided on clinicaltrials.gov indicate that this investigation is actively seeking volunteers. The trial was initially posted on April 3rd, 2024, and the most recent update occurred on April 15th, 2024. A total of 780 participants are sought across three designated sites."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"Affirmative. The information on clinicaltrials.gov reveals that this research study is presently seeking volunteers to participate. Initially shared on April 3rd, 2024, the most recent update was made on April 15th of the same year. A total of 780 individuals are being sought across three designated locations for inclusion in this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

2024. "A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06312137.

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