Phase
Condition
Neoplasms
Treatment
Pembrolizumab (neoadjuvant)
H2 receptor antagonist
Pembrolizumab (adjuvant)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Has previously untreated and pathologically confirmed resectable Stage II, IIIA, orIIIB (N2) non-small cell lung cancer (NSCLC)
Able to undergo protocol therapy, including necessary surgery
Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is notindicated as primary therapy
Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1as assessed within 10 days before initiation of study intervention.
Is able to provide archival or newly obtained core/excisional biopsy of the primarylung tumor or lymph node metastasis.
Exclusion
Exclusion Criteria:
Has one of the following tumor locations/types: NSCLC involving the superior sulcus,large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-smallcell elements, or sarcomatoid tumor.
Has Grade ≥2 peripheral neuropathy.
Has history of documented severe dry eye syndrome, severe Meibomian gland diseaseand/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
Has active inflammatory bowel disease requiring immunosuppressive medication orprevious history of inflammatory bowel disease (eg, Crohn's disease, ulcerativecolitis, or chronic diarrhea).
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
Received a live or live-attenuated vaccine within 30 days before the first dose ofstudy intervention
Received prior radiotherapy within 2 weeks of start of study intervention, orradiation related toxicities, requiring corticosteroids.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (indosing exceeding 10 mg daily of prednisone equivalent) or any other form ofimmunosuppressive therapy within 7 days prior to the first dose of studyintervention.
Known additional malignancy that is progressing or has required active treatmentwithin the past 5 years.
Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Active autoimmune disease that has required systemic treatment in the past 2 years.Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid) isallowed.
History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease.
Active infection requiring systemic therapy.
Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or Hepatitis Cvirus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) [qualitative]) infection.
Known history of human immunodeficiency virus (HIV) infection.
History of allogeneic tissue/solid organ transplant.
Study Design
Connect with a study center
Bradfordhill ( Site 0160)
Santiago, Region M. de Santiago 8420383
ChileActive - Recruiting
Centro de Estudios Clínicos SAGA ( Site 0162)
Santiago, Region M. de Santiago 7500653
ChileActive - Recruiting
FALP ( Site 0161)
Santiago, Region M. de Santiago 7500921
ChileActive - Recruiting
Bradfordhill ( Site 0160)
Santiago 3871336, Region M. de Santiago 8420383
ChileActive - Recruiting
Centro de Estudios Clínicos SAGA ( Site 0162)
Santiago 3871336, Region M. de Santiago 7500653
ChileActive - Recruiting
ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202)
Athens, Attica 12462
GreeceActive - Recruiting
Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203)
Athens, Attica 115 28
GreeceActive - Recruiting
Metropolitan Hospital-4th Oncology Dept ( Site 0201)
Athens, Attica 185 47
GreeceActive - Recruiting
Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203)
Athens 264371, Attica 6692632 115 28
GreeceActive - Recruiting
Metropolitan Hospital-4th Oncology Dept ( Site 0201)
Athens 264371, Attica 6692632 185 47
GreeceActive - Recruiting
University General Hospital of Heraklion ( Site 0200)
Heraklion, Irakleio 71110
GreeceActive - Recruiting
Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 0062)
Győr, Győr-Moson-Sopron 9024
HungaryActive - Recruiting
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0061)
Szolnok, Jász-Nagykun-Szolnok 5000
HungaryActive - Recruiting
Országos Korányi Pulmonológiai Intézet ( Site 0060)
Budapest, 1121
HungaryActive - Recruiting
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, Tuscany 50134
ItalyActive - Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
Milan, 20133
ItalyActive - Recruiting
Ospedale San Raffaele. ( Site 0171)
Milan, 20132
ItalyActive - Recruiting
Ospedale San Raffaele. ( Site 0171)
Milan 6951411, 20132
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
Roma, 00168
ItalyActive - Recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153)
Poznan, Greater Poland Voivodeship 60-569
PolandActive - Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)
Warsaw, Masovian Voivodeship 02-781
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Pomeranian Voivodeship 80-952
PolandActive - Recruiting
Hospital Clinic de Barcelona ( Site 0092)
Barcelona, 08008
SpainActive - Recruiting
Hospital Clínic de Barcelona ( Site 0092)
Barcelona, 08008
SpainActive - Recruiting
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0702)
Adana, 01250
Turkey (Türkiye)Active - Recruiting
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700)
Ankara, 06230
Turkey (Türkiye)Active - Recruiting
Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 0704)
Antalya, 07059
Turkey (Türkiye)Active - Recruiting
İzmir Suat Seren Chest Disease Training & Research Hospital ( Site 0701)
Izmir, 35110
Turkey (Türkiye)Active - Recruiting
Ondokuz Mayıs Universitesi-Oncology department ( Site 0706)
Samsun, 55139
Turkey (Türkiye)Active - Recruiting
CNE CC of Oncology Hematol ( Site 0130)
Cherkasy, Cherkasy Oblast 18009
UkraineActive - Recruiting
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0139)
Chernivtsi, Chernivetska Oblast 58013
UkraineActive - Recruiting
CNCE Precarpathian Clinical Oncologic Center ( Site 0131)
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018
UkraineActive - Recruiting
MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132)
Lviv, Lviv Oblast 79059
UkraineActive - Recruiting
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460)
Rivne, Rivne Oblast 33010
UkraineActive - Recruiting
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0135)
Vinnytsia, Vinnytsia Oblast 21029
UkraineActive - Recruiting
Shalimov Institute of Surgery and Transplantation ( Site 0138)
Kyiv, 03126
UkraineActive - Recruiting
Southern Cancer Center (SCC) ( Site 8004)
Daphne, Alabama 36526
United StatesActive - Recruiting
Sansum Clinic (Ridley Tree) ( Site 8012)
Santa Barbara, California 93105
United StatesActive - Recruiting
Rocky Mountain Cancer Centers (RMCC) ( Site 8011)
Lone Tree, Colorado 80124
United StatesActive - Recruiting
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland 21237
United StatesActive - Recruiting
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8006)
Eugene, Oregon 97401
United StatesActive - Recruiting
Texas Oncology - Central/South Texas ( Site 8009)
Austin, Texas 78705
United StatesActive - Recruiting
Texas Oncology - Northeast Texas ( Site 8005)
Tyler, Texas 75702
United StatesActive - Recruiting
Virginia Cancer Specialists (VCS) ( Site 8002)
Fairfax, Virginia 22031
United StatesActive - Recruiting

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