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Clinical Trials in the USA / NCT06422143
Recruiting Phase 3

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

NCT06422143 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2024-06-10
Last updated
2026-09-03

Condition(s) studied

Non-small Cell Lung CancerNSCLC

Investigational drug(s) / intervention(s)

Pembrolizumabsac-TMTCarboplatinPaclitaxelNab-paclitaxel

Pembrolizumab: Intravenous (IV) infusion

sac-TMT: IV infusion

Carboplatin: Participants receive AUC 6 or AUC 5 mg/mL/min IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.

Paclitaxel: Participants receive 200 mg/m\^2 or 175 mg/m\^2 IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.

Nab-paclitaxel: Participants receive 100 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 21-day cycle for 4 cycles as background therapy during the study.

Study summary

This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (216)

FacilityCityRegionStatus
CARTI Cancer Center ( Site 0006) Little Rock Arkansas Recruiting
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0122) Burbank California Recruiting
Sharp Memorial Hospital ( Site 9544) San Diego California Recruiting
Intermountain Health Cancer Center Lutheran Hospital ( Site 0119) Golden Colorado Recruiting
Intermountain Health St. Mary's Regional Hospital ( Site 0116) Grand Junction Colorado Recruiting
Washington Hospital Center ( Site 0037) Washington D.C. District of Columbia Recruiting
Mid Florida Hematology and Oncology Center ( Site 0109) Orange City Florida Completed
Centricity Research Columbus Cancer Center ( Site 0111) Columbus Georgia Completed
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0001) Marietta Georgia Completed
Southeastern Regional Medical Center ( Site 0004) Newnan Georgia Completed
University of Chicago Medical Center ( Site 0145) Chicago Illinois Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor ( Site 9552) Ypsilanti Michigan Recruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0146) Minneapolis Minnesota Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0035) Hackensack New Jersey Recruiting
Capital Health Medical Center - Hopewell ( Site 0034) Pennington New Jersey Recruiting
New Mexico Oncology Hematology Consultants Ltd. ( Site 0123) Albuquerque New Mexico Completed
University of New Mexico Comprehensive Cancer Center ( Site 0135) Albuquerque New Mexico Recruiting
St Luke's University Health Network ( Site 0017) Bethlehem Pennsylvania Recruiting
Thomas Jefferson University - Clinical Research Institute ( Site 0147) Philadelphia Pennsylvania Recruiting
Memorial Hermann Cancer Center ( Site 0015) Houston Texas Recruiting
Oncology Consultants P.A. ( Site 0124) Houston Texas Recruiting
Mays Cancer Center ( Site 0132) San Antonio Texas Completed
Instituto Alexander Fleming ( Site 0203) Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0200) Mar del Plata Buenos Aires Recruiting
Instituto Médico Río Cuarto ( Site 0204) Río Cuarto Córdoba Province Recruiting
Fundacion Intecnus ( Site 0205) Bariloche Río Negro Province Recruiting
Sanatorio Parque ( Site 0201) Rosario Santa Fe Province Recruiting
Hospital Aleman-Oncology ( Site 0202) Buenos Aires Argentina Recruiting
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0720) Linz Upper Austria Recruiting
Klinik Hietzing ( Site 0740) Vienna Austria Recruiting
Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0730) Vienna Austria Recruiting
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0710) Vienna Austria Recruiting
Hospital do Cancer de Pernambuco ( Site 0312) Recife Pernambuco Recruiting
Vencer Centro de Pesquisa Clínica ( Site 0309) Teresina Piauí Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0311) Porto Alegre Rio Grande do Sul Recruiting
Hospital Nossa Senhora da Conceição ( Site 0300) Porto Alegre Rio Grande do Sul Recruiting
Instituto de Oncologia Saint Gallen ( Site 0304) Santa Cruz do Sul Rio Grande do Sul Recruiting
Hospital de Base de São José do Rio Preto ( Site 0310) São José do Rio Preto São Paulo Recruiting
Hospital Paulistano ( Site 0307) São Paulo Brazil Recruiting
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0100) Kingston Ontario Recruiting

+ 176 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06422143 on ClinicalTrials.gov ↗ ← All trials in the USA