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%.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

217

Study ID:

NCT03631784

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 56 Locations for this study

See Locations Near You

St Joseph Heritage Healthcare ( Site 1403)
Santa Rosa California, 95403, United States
North Shore University Health System ( Site 1413)
Evanston Illinois, 60201, United States
Parkview Cancer Institute ( Site 1415)
Fort Wayne Indiana, 46845, United States
UMass Memorial Medical Center ( Site 1417)
Worcester Massachusetts, 01655, United States
Henry Ford Hospital ( Site 1418)
Detroit Michigan, 48202, United States
St. Francis Cancer Treatment Center ( Site 1421)
Grand Island Nebraska, 68803, United States
Rutgers Cancer Institute of New Jersey ( Site 1422)
New Brunswick New Jersey, 08903, United States
CTCA Southwestern ( Site 1428)
Tulsa Oklahoma, 74133, United States
Fox Chase Cancer Center ( Site 1433)
Philadelphia Pennsylvania, 19111, United States
Sanford Cancer Center Oncology Clinic ( Site 1434)
Sioux Falls South Dakota, 57104, United States
Blacktown Hospital Western Sydney Local Health District ( Site 0204)
Blacktown New South Wales, 2148, Australia
MNCCI Port Macquarie Base Hospital ( Site 0200)
Port Macquarie New South Wales, 2444, Australia
Southern Medical Day Care Centre ( Site 0201)
Wollongong New South Wales, 2500, Australia
Ballarat Health Services ( Site 0206)
Ballarat Victoria, 3350, Australia
C.H. de Saint Quentin ( Site 0306)
Saint Quentin Aisne, 02321, France
Clinique Clairval ( Site 0311)
Marseille Bouches-du-Rhone, 13009, France
CHU Jean Minjoz ( Site 0301)
Besancon Doubs, 25000, France
Institut du Cancer de Montpellier ( Site 0300)
Montpellier Herault, 34298, France
C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0302)
Rennes. Ille-et-Vilaine, 35033, France
ICO Centre Paul Papin ( Site 0309)
Angers Maine-et-Loire, 49055, France
Centre Jean Perrin ( Site 0304)
Clermont Ferrand Puy-de-Dome, 63011, France
Clinique de L'Europe ( Site 0308)
Amiens Somme, 80000, France
Institut de Cancerologie Gustave Roussy ( Site 0305)
Villejuif Val-de-Marne, 94800, France
Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0404)
Heidelberg Baden-Wurttemberg, 69126, Germany
Universitatsklinikum Mannheim GmbH ( Site 0413)
Mannheim Baden-Wurttemberg, 68167, Germany
Augusta-Kranken-Anstalt Bochum ( Site 0401)
Bochum Nordrhein-Westfalen, 44791, Germany
Bethanien Krankenhaus Moers ( Site 0406)
Moers Nordrhein-Westfalen, 47441, Germany
Klinikum Chemnitz gGmbH ( Site 0410)
Chemnitz Sachsen, 09113, Germany
LungenClinic Grosshansdorf GmbH ( Site 0408)
Grosshansdorf Schleswig-Holstein, 22927, Germany
Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 0414)
Berlin , 13353, Germany
Katholisches Marienkrankenhaus gGmbH ( Site 0411)
Hamburg , 22087, Germany
Chungbuk National University Hospital ( Site 1003)
Cheongju si Chungcheongbuk-do [Chungbuk], 28644, Korea, Republic of
National Cancer Center ( Site 1002)
Goyang-si Kyonggi-do, 10408, Korea, Republic of
Samsung Medical Center ( Site 1001)
Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of
Ulsan University Hospital ( Site 1000)
Ulsan Ulsan-Kwangyokshi, 44033, Korea, Republic of
Auckland City Hospital ( Site 0700)
Auckland , 1023, New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0811)
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym ( Site 0802)
Krakow Malopolskie, 31-82, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0800)
Warszawa Mazowieckie, 02-78, Poland
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 0812)
Gdynia Pomorskie, 81-51, Poland
Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0813)
Koszalin Zachodniopomorskie, 75-58, Poland
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0903)
Ufa Baskortostan, Respublika, 45005, Russian Federation
Blokhin National Medical Oncology ( Site 0902)
Moscow Moskva, 11547, Russian Federation
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0904)
St. Petersburg Sankt-Peterburg, 19775, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0910)
Kazan Tatarstan, Respublika, 42002, Russian Federation
Hospital Universitari Vall d Hebron ( Site 1101)
Barcelona Barcelona [Barcelona], 08035, Spain
Hospital Clinic de Barcelona ( Site 1100)
Barcelona Barcelona [Barcelona], 08036, Spain
Hospital Son Llatzer ( Site 1105)
Palma de Mallorca Illes Balears [Islas Baleares], 07198, Spain
Clinica Universitaria de Navarra ( Site 1102)
Madrid , 28027, Spain
Hospital Universitario Virgen Macarena ( Site 1103)
Sevilla , 41009, Spain
Southampton General Hospital ( Site 1204)
Southampton Hampshire, SO16 , United Kingdom
Royal Free NHS Foundation Trust ( Site 1200)
London London, City Of, NW3 2, United Kingdom
Charing Cross Hospital ( Site 1208)
London London, City Of, W6 8R, United Kingdom
Beacon Centre ( Site 1203)
Taunton Somerset, TA1 5, United Kingdom
Leeds Teaching Hospitals NHS Trust ( Site 1209)
Leeds , LS9 7, United Kingdom
Queen's Hospital ( Site 1201)
Rom Valley , RM7 0, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

217

Study ID:

NCT03631784

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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