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Pembrolizumab with or without Sacituzumab Tirumotecan for Metastatic Squamous NSCLC

This study is testing a new approach for people with advanced squamous non-small cell lung cancer (NSCLC). It combines standard chemotherapy (carboplatin and paclitaxel or nab-paclitaxel) and pembrolizumab with or without an additional drug called sacituzumab tirumotecan (Sac-TMT). The goal is to see if adding Sac-TMT improves how long people live (overall survival) compared to pembrolizumab alone after initial treatment. You would need to have squamous NSCLC that has spread (metastatic) and can be measured. The study aims to enroll 851 participants.

Study design
This is a Phase 3 interventional study. After an initial treatment phase, participants will be randomly assigned to receive either pembrolizumab alone or pembrolizumab plus sacituzumab tirumotecan.
What's involved
You would receive initial treatment for four 21-day cycles, followed by ongoing maintenance treatment. The study will track your health for up to approximately 50 months.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be measured for up to approximately 50 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06422143

Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~851 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:Pembrolizumabsac-TMTCarboplatinPaclitaxelNab-paclitaxel

At a glance

Recruiting sites
172 of 216 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over Up to ~50 months

Conditions

Non-small Cell Lung Cancer
NSCLC

Explore related trials

Lung Non-Small Cell Squamous Carcinoma

NCT06422143

Where you'd take part

This study runs at 216 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aichi Cancer Center ( Site 2502)

    Nagoya, Aichi-ken, Japanstudy coordinator listed

    Recruiting

  • Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0146)

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1800)

    Ankara, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Asan Medical Center ( Site 2105)

    Seoul, South Koreastudy coordinator listed

    Recruiting

  • Azienda Ospedaliera Maggiore della Carita ( Site 1416)

    Novara, Italystudy coordinator listed

    Recruiting

  • Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1409)

    Rome, Lazio, Italystudy coordinator listed

    Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 1414)

    Brescia, Italystudy coordinator listed

    Recruiting

  • Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 1100)

    Kecskemét, Bács-Kiskun county, Hungarystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) \[Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8\]
Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiology
Has life expectancy ≥3 months
Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation
Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Participants who have adverse events (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)
Has adequate organ function
For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 or most recent scan before randomization
For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit
For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade ≤2 fatigue, Grade ≤2 peripheral neuropathy, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered
For Maintenance only (prior to randomization): has not experienced a pneumonitis/interstitial lung disease (ILD) event during the study-specified induction

Exclusion

Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention
HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T lymphocyte-associated protein 4, OX-40, CD137). Note: Prior treatment with an anti-PD-1 or anti-PD-L1 agent for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antidrug conjugate (ADC)
Received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention
Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Participants who have not adequately recovered from major surgery or have ongoing surgical complications
Received prior treatment with a topoisomerase I inhibitor-containing ADC
Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks)
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has known central nervous system (CNS) metastases/carcinomatous meningitis
Severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients or to another biologic therapy
Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy \[eg, thyroxine, insulin, or physiologic corticosteroid\] is allowed)
Has a history of (noninfectious)pneumonitis/ILD that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
Active infection requiring systemic therapy
History of allogeneic tissue/solid organ transplant

What this trial measures

  • Overall survival (OS)Up to ~50 months

    OS is the time from randomization to death due to any cause.