Last updated 5 days ago
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
851 patients around the world
Available in Argentina
All participants undergo an initial induction phase of four cycles, each cycle consisting
of pembrolizumab every 3 weeks (q3w) + carboplatin q3w + paclitaxel q3w or nabpaclitaxel
weekly. Participants are then randomly assigned to pembrolizumab maintenance vs.
pembrolizumab + sac-TMT maintenance.
Merck Sharp & Dohme LLC
26Research sites
851Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically or cytologically confirmed diagnosis of squamous 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/radiologyHas 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 providedHuman 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 recoveredFor Maintenance only (prior to randomization): has adequate organ function.
- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elementsGrade ≥2 peripheral neuropathyHistory of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healingActive inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel diseaseHas 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 interventionHIV-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 NSCLCReceived 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 NSCLCReceived prior treatment with a tumor-associated calcium signal transducer 2 (TROP2)-targeted antidrug conjugate (ADC)Received prior systemic anticancer therapy including investigational agents within 4 weeks before allocation.Received radiation therapy to the lung that is >30 Gray within 6 months of start of study interventionReceived prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroidsReceived a live or live-attenuated vaccine within 30 days before the first dose of study intervention.Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.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 (participants with previously treated brain metastases may participate provided they are clinically stable for t least 2 weeks and, have no evidence of new or enlarging brain metastases and also are off steroids 3 days prior to dosing with study medication. Subjects with known untreated, asymptomatic brain metastases [ie, no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesion >1.5 cm] may participate but will require regular imaging of the brain as a site of disease).Severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients or to another biologic therapyActive autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy [eg, thyroxine, insulin, or physiologic corticosteroid] is allowed).History of (noninfectious)pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.Active infection requiring systemic therapy.History of allogeneic tissue/solid organ transplant.
Sites
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Fundación Intecnus
Recruiting
Instituto Médico Río Cuarto
Recruiting
Hospital Alemán
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Sanatorio Parque - Rosario
Recruiting
Hospital Paulistano
Recruiting
Vencer e Oncoclinica - Oncoclínica Oncologistas Associados
Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Recruiting
Hospital Nossa Senhora da Conceição
Recruiting
StudyMK-2870-023
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06422143
