Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
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)
Overall survival (OS) — Up to ~50 months OS is the time from randomization to death due to any cause.
Trial sites (216)
Facility
City
Region
Status
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.
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.
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