A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)

PHASE2CompletedINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

October 19, 2018

Primary Completion Date

October 18, 2021

Study Completion Date

March 19, 2024

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

Pembrolizumab 200 mg

Pembrolizumab 200 mg intravenous (IV) infusion on Days 1 of each 3-week cycle for up to 17 cycles

DRUG

Paclitaxel 45 mg/m^2

Paclitaxel 45 mg/m\^2 IV infusion on Days 1, 8, 15 of each 3-week cycle for Cycles 2, and 3 during radiation therapy.

DRUG

Carboplatin AUC6

Carboplatin AUC6 IV infusion on Day 1 of the 21-day cycle for Cycle 1.

DRUG

Cisplatin 75 mg/m^2

Cisplatin 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle for Cycles 1, 2, 3.

DRUG

Pemetrexed 500 mg/m^2

Pemetrexed 500 mg/m\^2 IV infusion on Day 1 of each 21-day cycle for Cycles 1, 2, and 3.

RADIATION

Thoracic Radiation Therapy (TRT)

The target total dose of TRT will be 60 Gy in 30 daily fractions of 2 Gy, prescribed to the planning target volume.

DRUG

Paclitaxel 200 mg/m^2

Paclitaxel 200 mg/m\^2 IV infusion on Day 1 of the 21-day cycle of Cycle 1.

DRUG

Carboplatin AUC2

Carboplatin AUC2 IV infusion on Day 1, 8, 15 for Cycles 2 and 3 during radiation therapy.

Trial Locations (56)

1023

Auckland City Hospital ( Site 0700), Auckland

2148

Blacktown Hospital Western Sydney Local Health District ( Site 0204), Blacktown

2444

MNCCI Port Macquarie Base Hospital ( Site 0200), Port Macquarie

2500

Southern Medical Day Care Centre ( Site 0201), Wollongong

3350

Ballarat Health Services ( Site 0206), Ballarat

10408

National Cancer Center ( Site 1002), Goyang-si

13009

Clinique Clairval ( Site 0311), Marseille

13353

Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 0414), Berlin

19111

Fox Chase Cancer Center ( Site 1433), Philadelphia

22087

Katholisches Marienkrankenhaus gGmbH ( Site 0411), Hamburg

22927

LungenClinic Grosshansdorf GmbH ( Site 0408), Großhansdorf

25000

CHU Jean Minjoz ( Site 0301), Besançon

28027

Clinica Universitaria de Navarra ( Site 1102), Madrid

28644

Chungbuk National University Hospital ( Site 1003), Cheongju-si

34298

Institut du Cancer de Montpellier ( Site 0300), Montpellier

35033

C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0302), Rennes

41009

Hospital Universitario Virgen Macarena ( Site 1103), Seville

44033

Ulsan University Hospital ( Site 1000), Ulsan

44791

Augusta-Kranken-Anstalt Bochum ( Site 0401), Bochum

46845

Parkview Cancer Institute ( Site 1415), Fort Wayne

47441

Bethanien Krankenhaus Moers ( Site 0406), Moers

48202

Henry Ford Hospital ( Site 1418), Detroit

49055

ICO Centre Paul Papin ( Site 0309), Angers

57104

Sanford Cancer Center Oncology Clinic ( Site 1434), Sioux Falls

60201

North Shore University Health System ( Site 1413), Evanston

63011

Centre Jean Perrin ( Site 0304), Clermont-Ferrand

68167

Universitatsklinikum Mannheim GmbH ( Site 0413), Mannheim

68803

St. Francis Cancer Treatment Center ( Site 1421), Grand Island

69126

Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0404), Heidelberg

74133

CTCA Southwestern ( Site 1428), Tulsa

80000

Clinique de L'Europe ( Site 0308), Amiens

94800

Institut de Cancerologie Gustave Roussy ( Site 0305), Villejuif

95403

St Joseph Heritage Healthcare ( Site 1403), Santa Rosa

115478

Blokhin National Medical Oncology ( Site 0902), Moscow

197758

National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0904), Saint Petersburg

420029

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0910), Kazan'

450054

Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0903), Ufa

01655

UMass Memorial Medical Center ( Site 1417), Worcester

08903

Rutgers Cancer Institute of New Jersey ( Site 1422), New Brunswick

02321

C.H. de Saint Quentin ( Site 0306), Saint-Quentin

09113

Klinikum Chemnitz gGmbH ( Site 0410), Chemnitz

85-796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0811), Bydgoszcz

31-826

Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym ( Site 0802), Krakow

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0800), Warsaw

81-519

Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 0812), Gdynia

75-581

Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0813), Koszalin

06351

Samsung Medical Center ( Site 1001), Seoul

08035

Hospital Universitari Vall d Hebron ( Site 1101), Barcelona

08036

Hospital Clinic de Barcelona ( Site 1100), Barcelona

07198

Hospital Son Llatzer ( Site 1105), Palma de Mallorca

SO16 6YD

Southampton General Hospital ( Site 1204), Southampton

NW3 2QG

Royal Free NHS Foundation Trust ( Site 1200), London

W6 8RF

Charing Cross Hospital ( Site 1208), London

TA1 5DA

Beacon Centre ( Site 1203), Taunton

RM7 0AG

Queen's Hospital ( Site 1201), Rom Valley

LS9 7TF

Leeds Teaching Hospitals NHS Trust ( Site 1209), Leeds

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03631784 - A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799) | Biotech Hunter | Biotech Hunter