Recruiting

TroFuse-019Pembrolizumab and Sacituzumab Tirumotecan for Resectable NSCLC Without Complete Response

Study Aim

The study evaluates whether the combination of Pembrolizumab and Sacituzumab Tirumotecan can improve disease-free survival in patients with resectable non-small cell lung cancer who do not achieve a complete response.

What is being tested

Sacituzumab tirumotecan

+ Pembrolizumab

+ Rescue medication

BiologicalDrug

Who is being recruted

Bronchial Neoplasms+10

+ Carcinoma

+ Carcinoma, Bronchogenic

Over 18 Years

+29 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: April 2024

See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC

Study ContactToll Free Number

Last updated: March 21, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 3, 2024

Actual date on which the first participant was enrolled.

This clinical trial is focused on treating individuals who have non-small cell lung cancer (NSCLC) that can be surgically removed, specifically at stages II to IIIB (N2). The study targets those who did not achieve a complete response in their cancer tissue after receiving a combination of pembrolizumab, a type of immunotherapy, and platinum-based chemotherapy before surgery. The goal is to determine if adding a drug called sacituzumab tirumotecan to pembrolizumab after surgery can improve the length of time patients live without their cancer returning, known as disease-free survival. Participants in this trial will receive treatment either with pembrolizumab alone or with a combination of pembrolizumab and sacituzumab tirumotecan, administered after their surgery. The effectiveness of these treatments will be assessed by an independent review team who will not know which treatment each participant is receiving. They will evaluate how long participants remain free from cancer recurrence. The study aims to see if the combination treatment can provide better outcomes than using pembrolizumab by itself. As it is an open-label study, participants and researchers will know which treatment is being administered.

Official TitleA Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery

NCT06312137

Principal SponsorMerck Sharp & Dohme LLC

Study ContactToll Free Number

Last updated: March 21, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

780 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinomaCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

9 inclusion criteria required to participate

Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement [N2]) per AJCC eighth edition guidelines

Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy

Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible

Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

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20 exclusion criteria prevent from participating

Has one of the following tumor locations/types: NSCLC involving the superior sulcus, Large cell neuro-endocrine cancer (LCNEC), Sarcomatoid tumor, Diagnosis of SCLC or, for mixed tumors, presence of small cell elements

Has Grade ≥2 peripheral neuropathy

Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing

Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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 12 doses (\~24 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (\~42 weeks).

Group II

Active Comparator

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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 257 locations

Recruiting

UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)

Little Rock, United StatesOpen UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060) in Google Maps

Recruiting

Highlands Oncology Group-Research Department ( Site 0062)

Springdale, United States

Recruiting

Beverly Hills Cancer Center ( Site 0070)

Beverly Hills, United States

Recruiting

The Angeles Clinic and Research Institute ( Site 0040)

Los Angeles, United States

Recruiting

257 Study Centers