60
Participants
Start Date
March 20, 2025
Primary Completion Date
February 6, 2032
Study Completion Date
February 6, 2032
Pembrolizumab (neoadjuvant)
Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles
Cisplatin
Cisplatin 75 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
Gemcitabine
In squamous tumors Gemcitabine 1000 mg/m\^2 by IV infusion on day 1 and day 8 of each 21-day cycle for 4 cycles.
Pemetrexed
In nonsquamous tumors Pemetrexed 500 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
Sacituzumab tirumotecan
Sacituzumab tirumotecan 4 mg/kg by IV infusion on day 1 of each 14-day cycle for up to 6 cycles
H1 receptor antagonist
Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
H2 receptor antagonist
Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
Acetaminophen (or equivalent)
Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
Dexamethasone (or equivalent)
Administered as rescue medication 8 -10 mg before Sacituzumab tirumotecan infusion per approved product label
Carboplatin
AUC 5 mg/mL min or AUC 6 mg/mL min by IV infusion on day 1 of each 21-day cycle for 4 cycles
Pembrolizumab (adjuvant)
After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles
Paclitaxel
Paclitaxel 175 or 200 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles.
Steroid mouthwash (dexamethasone or equivalent)
Administered orally as rescue medication 2-5 mL 4 times daily
RECRUITING
Országos Korányi Pulmonológiai Intézet ( Site 0060), Budapest
RECRUITING
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0061), Szolnok
RECRUITING
Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 0062), Győr
RECRUITING
ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202), Athens
RECRUITING
CNE CC of Oncology Hematol ( Site 0130), Cherkasy
RECRUITING
Ospedale San Raffaele. ( Site 0171), Milan
RECRUITING
"Communal Noncommercial Enterprise Podillia Regional Oncology Center Of Vinnytsia Regional Council ( Site 0135)", Vinnytsia
RECRUITING
MedStar Franklin Square Medical Center ( Site 0033), Baltimore
RECRUITING
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460), Rivne
RECRUITING
Azienda Ospedaliera Universitaria Careggi ( Site 0173), Florence
RECRUITING
"Municipal Enterprise Bukovinian сlinical oncology сenter ( Site 0139)", Chernivtsi
RECRUITING
University General Hospital of Heraklion ( Site 0200), Heraklion
RECRUITING
CNCE Precarpathian Clinical Oncologic Center ( Site 0131), Ivano-Frankivsk
RECRUITING
MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132), Lviv
RECRUITING
Centro de Estudios Clínicos SAGA ( Site 0162), Santiago
RECRUITING
FALP ( Site 0161), Santiago
RECRUITING
Bradfordhill ( Site 0160), Santiago
RECRUITING
Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203), Athens
RECRUITING
Metropolitan Hospital-4th Oncology Dept ( Site 0201), Athens
RECRUITING
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174), Roma
RECRUITING
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153), Poznan
RECRUITING
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151), Warsaw
RECRUITING
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150), Gdansk
RECRUITING
Hospital Clínic de Barcelona ( Site 0092), Barcelona
RECRUITING
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700), Ankara
RECRUITING
Shalimov Institute of Surgery and Transplantation ( Site 0138), Kyiv
Merck Sharp & Dohme LLC
INDUSTRY