Phase
Condition
Neoplasms
Treatment
Pemetrexed
Carboplatin
Pembrolizumab (neoadjuvant)
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
FALP ( Site 0161)
Santiago, Region M. De Santiago 7500921
ChileActive - Recruiting
Centro de Estudios Clínicos SAGA ( Site 0162)
Santiago., Region M. De Santiago 7500653
ChileActive - Recruiting
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Firenze, Toscana 50134
ItalyActive - Recruiting
Ospedale San Raffaele. ( Site 0171)
Milano, 20132
ItalyActive - Recruiting
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Pomorskie 80-952
PolandActive - Recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153)
Poznan, Wielkopolskie 60-569
PolandActive - Recruiting
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700)
Ankara, 06230
TurkeyActive - Recruiting
CNE CC of Oncology Hematol ( Site 0130)
Cherkasy, Cherkaska Oblast 18009
UkraineActive - Recruiting
MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132)
Lviv, Lvivska Oblast 79059
UkraineActive - Recruiting
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland 21237
United StatesActive - Recruiting
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