Lung Cancer Clinical Trial
A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799).
Summary
This is a trial in adult participants with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC) treated with pembrolizumab in combination with platinum doublet chemotherapy and standard thoracic radiotherapy followed by pembrolizumab monotherapy. The primary hypothesis of the trial is that within each platinum doublet chemotherapy cohort, the percentage of participants who develop Grade 3 or higher pneumonitis is ≤10%.
Eligibility Criteria
Inclusion Criteria:
Male/female participants, who are at least 18 years of age on the day of signing informed consent with previously untreated, unresectable, pathologically confirmed NSCLC and Stage IIIA, IIIB or IIIC NSCLC by American Joint Committee on Cancer Version 8.
No evidence of metastatic disease by whole body positron emission tomography/computed tomography (PET/ CT) scan, diagnostic quality CT scan, and brain imaging.
Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
Have provided tumor tissue sample (core, incisional, or excisional biopsy).
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Have adequate pulmonary function test (PFT)
Have adequate organ function
A male participant must agree to use contraception through the end of treatment and refrain from donating sperm during this period.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and if participant is a woman of childbearing potential (WOCBP), agrees to follow the contraceptive guidance as provided in the protocol through the end of treatment.
Exclusion Criteria:
A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment allocation
Has small cell lung cancer.
Has had documented weight loss >10% in the preceding 3 months.
Participants whose radiation treatment plans are likely to encompass a volume of whole lung receiving >20 Gy in total (V20) of more than 31% of lung volume.
Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus or for breast cancer.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent (programmed cell death protein 1 [PD-1] and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 [PD-L2]) or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
Has received a live vaccine within 30 days prior to the first dose of study drug.
Has had an allogenic tissue/solid organ transplant.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
Has severe hypersensitivity (Grade 3 or higher) to pembrolizumab and/or any of its excipients.
Has a known severe hypersensitivity (Grade 3 or higher) to any of the study chemotherapy agents and/or to any of their excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Has a known psychiatric or substance abuse disorder that would interfere with cooperating with the requirements of the study.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study through the end of treatment.
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There are 56 Locations for this study
Santa Rosa California, 95403, United States
Evanston Illinois, 60201, United States
Fort Wayne Indiana, 46845, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48202, United States
Grand Island Nebraska, 68803, United States
New Brunswick New Jersey, 08903, United States
Tulsa Oklahoma, 74133, United States
Philadelphia Pennsylvania, 19111, United States
Sioux Falls South Dakota, 57104, United States
Blacktown New South Wales, 2148, Australia
Port Macquarie New South Wales, 2444, Australia
Wollongong New South Wales, 2500, Australia
Ballarat Victoria, 3350, Australia
Saint Quentin Aisne, 02321, France
Marseille Bouches-du-Rhone, 13009, France
Besancon Doubs, 25000, France
Montpellier Herault, 34298, France
Rennes. Ille-et-Vilaine, 35033, France
Angers Maine-et-Loire, 49055, France
Clermont Ferrand Puy-de-Dome, 63011, France
Amiens Somme, 80000, France
Villejuif Val-de-Marne, 94800, France
Heidelberg Baden-Wurttemberg, 69126, Germany
Mannheim Baden-Wurttemberg, 68167, Germany
Bochum Nordrhein-Westfalen, 44791, Germany
Moers Nordrhein-Westfalen, 47441, Germany
Chemnitz Sachsen, 09113, Germany
Grosshansdorf Schleswig-Holstein, 22927, Germany
Berlin , 13353, Germany
Hamburg , 22087, Germany
Cheongju si Chungcheongbuk-do [Chungbuk], 28644, Korea, Republic of
Goyang-si Kyonggi-do, 10408, Korea, Republic of
Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of
Ulsan Ulsan-Kwangyokshi, 44033, Korea, Republic of
Auckland , 1023, New Zealand
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Krakow Malopolskie, 31-82, Poland
Warszawa Mazowieckie, 02-78, Poland
Gdynia Pomorskie, 81-51, Poland
Koszalin Zachodniopomorskie, 75-58, Poland
Ufa Baskortostan, Respublika, 45005, Russian Federation
Moscow Moskva, 11547, Russian Federation
St. Petersburg Sankt-Peterburg, 19775, Russian Federation
Kazan Tatarstan, Respublika, 42002, Russian Federation
Barcelona Barcelona [Barcelona], 08035, Spain
Barcelona Barcelona [Barcelona], 08036, Spain
Palma de Mallorca Illes Balears [Islas Baleares], 07198, Spain
Madrid , 28027, Spain
Sevilla , 41009, Spain
Southampton Hampshire, SO16 , United Kingdom
London London, City Of, NW3 2, United Kingdom
London London, City Of, W6 8R, United Kingdom
Taunton Somerset, TA1 5, United Kingdom
Leeds , LS9 7, United Kingdom
Rom Valley , RM7 0, United Kingdom
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