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

Completed · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

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% and estimation of objective response rate (ORR) by blinded independent central review (BICR).

Key facts

Study ID: NCT03631784
Run by: Merck Sharp & Dohme LLC
People needed: 216
Starts: 2018-10-19
Expected to finish: 2024-03-19
Last updated by the study team: 2025-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

North Shore University Health System ( Site 1413) — Evanston, Illinois, United States
Parkview Cancer Institute ( Site 1415) — Fort Wayne, Indiana, United States
UMass Memorial Medical Center ( Site 1417) — Worcester, Massachusetts, United States
Henry Ford Hospital ( Site 1418) — Detroit, Michigan, United States
St. Francis Cancer Treatment Center ( Site 1421) — Grand Island, Nebraska, United States
Rutgers Cancer Institute of New Jersey ( Site 1422) — New Brunswick, New Jersey, United States
CTCA Southwestern ( Site 1428) — Tulsa, Oklahoma, United States
Fox Chase Cancer Center ( Site 1433) — Philadelphia, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic ( Site 1434) — Sioux Falls, South Dakota, United States
Blacktown Hospital Western Sydney Local Health District ( Site 0204) — Blacktown, New South Wales, Australia
MNCCI Port Macquarie Base Hospital ( Site 0200) — Port Macquarie, New South Wales, Australia
Southern Medical Day Care Centre ( Site 0201) — Wollongong, New South Wales, Australia
Ballarat Health Services ( Site 0206) — Ballarat, Victoria, Australia
C.H. de Saint Quentin ( Site 0306) — Saint-Quentin, Aisne, France
Clinique Clairval ( Site 0311) — Marseille, Bouches-du-Rhone, France
CHU Jean Minjoz ( Site 0301) — Besançon, Doubs, France
Institut du Cancer de Montpellier ( Site 0300) — Montpellier, Herault, France
C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0302) — Rennes, Ille-et-Vilaine, France
ICO Centre Paul Papin ( Site 0309) — Angers, Maine-et-Loire, France
Centre Jean Perrin ( Site 0304) — Clermont-Ferrand, Puy-de-Dome, France
Clinique de L'Europe ( Site 0308) — Amiens, Somme, France
Institut de Cancerologie Gustave Roussy ( Site 0305) — Villejuif, Val-de-Marne, France
Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0404) — Heidelberg, Baden-Wurttemberg, Germany
Universitatsklinikum Mannheim GmbH ( Site 0413) — Mannheim, Baden-Wurttemberg, Germany
St Joseph Heritage Healthcare ( Site 1403) — Santa Rosa, California, United States

Full record on ClinicalTrials.gov

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