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Pembrolizumab + Sacituzumab Tirumotecan for 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

Pivotal Trial

No Placebo-Only Group

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.

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.

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

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

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3150

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