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Non-small Cell Lung CancerPhase 2KEYNOTE-799NCT03631784

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

A Phase 2 study testing Pembrolizumab 200 mg, Paclitaxel 45 mg/m^2 and Carboplatin AUC6 in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 56 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Pembrolizumab 200 mg, Paclitaxel 45 mg/m^2 and Carboplatin AUC6
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
56 sitesin 10 countries
Study dates
19 Oct 2018to 19 Mar 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

56 sites in 10 countries.

56 sites in 10 countries

United States10 sites

  • Henry Ford Hospital ( Site 1418)

    Detroit, Michigan, 48202

  • North Shore University Health System ( Site 1413)

    Evanston, Illinois, 60201

  • Parkview Cancer Institute ( Site 1415)

    Fort Wayne, Indiana, 46845

  • St. Francis Cancer Treatment Center ( Site 1421)

    Grand Island, Nebraska, 68803

  • Rutgers Cancer Institute of New Jersey ( Site 1422)

    New Brunswick, New Jersey, 08903

  • Fox Chase Cancer Center ( Site 1433)

    Philadelphia, Pennsylvania, 19111

  • St Joseph Heritage Healthcare ( Site 1403)

    Santa Rosa, California, 95403

  • Sanford Cancer Center Oncology Clinic ( Site 1434)

    Sioux Falls, South Dakota, 57104

  • CTCA Southwestern ( Site 1428)

    Tulsa, Oklahoma, 74133

  • UMass Memorial Medical Center ( Site 1417)

    Worcester, Massachusetts, 01655

Other trials in United States

France9 sites

  • Clinique de L'Europe ( Site 0308)

    Amiens, Somme, 80000

  • ICO Centre Paul Papin ( Site 0309)

    Angers, Maine-et-Loire, 49055

  • CHU Jean Minjoz ( Site 0301)

    Besançon, Doubs, 25000

  • Centre Jean Perrin ( Site 0304)

    Clermont-Ferrand, Puy-de-Dome, 63011

  • Clinique Clairval ( Site 0311)

    Marseille, Bouches-du-Rhone, 13009

  • Institut du Cancer de Montpellier ( Site 0300)

    Montpellier, Herault, 34298

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

    Rennes, Ille-et-Vilaine, 35033

  • C.H. de Saint Quentin ( Site 0306)

    Saint-Quentin, Aisne, 02321

  • Institut de Cancerologie Gustave Roussy ( Site 0305)

    Villejuif, Val-de-Marne, 94800

Other trials in France

Germany8 sites

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

    Berlin, 13353

  • Augusta-Kranken-Anstalt Bochum ( Site 0401)

    Bochum, North Rhine-Westphalia, 44791

  • Klinikum Chemnitz gGmbH ( Site 0410)

    Chemnitz, Saxony, 09113

  • LungenClinic Grosshansdorf GmbH ( Site 0408)

    Großhansdorf, Schleswig-Holstein, 22927

  • Katholisches Marienkrankenhaus gGmbH ( Site 0411)

    Hamburg, 22087

  • Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0404)

    Heidelberg, Baden-Wurttemberg, 69126

  • Universitatsklinikum Mannheim GmbH ( Site 0413)

    Mannheim, Baden-Wurttemberg, 68167

  • Bethanien Krankenhaus Moers ( Site 0406)

    Moers, North Rhine-Westphalia, 47441

Other trials in Germany

United Kingdom6 sites

  • Leeds Teaching Hospitals NHS Trust ( Site 1209)

    Leeds, LS9 7TF

  • Royal Free NHS Foundation Trust ( Site 1200)

    London, London, City of, NW3 2QG

  • Charing Cross Hospital ( Site 1208)

    London, London, City of, W6 8RF

  • Queen's Hospital ( Site 1201)

    Rom Valley, United Kingdom, RM7 0AG

  • Southampton General Hospital ( Site 1204)

    Southampton, Hampshire, SO16 6YD

  • Beacon Centre ( Site 1203)

    Taunton, Somerset, TA1 5DA

Other trials in United Kingdom

Poland5 sites

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0811)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

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

    Gdynia, Pomeranian Voivodeship, 81-519

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

    Koszalin, West Pomeranian Voivodeship, 75-581

  • Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym ( Site 0802)

    Krakow, Lesser Poland Voivodeship, 31-826

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

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Spain5 sites

  • Hospital Universitari Vall d Hebron ( Site 1101)

    Barcelona, Barcelona [Barcelona], 08035

  • Hospital Clinic de Barcelona ( Site 1100)

    Barcelona, Barcelona [Barcelona], 08036

  • Clinica Universitaria de Navarra ( Site 1102)

    Madrid, 28027

  • Hospital Son Llatzer ( Site 1105)

    Palma de Mallorca, Illes Balears [Islas Baleares], 07198

  • Hospital Universitario Virgen Macarena ( Site 1103)

    Seville, 41009

Other trials in Spain

Australia4 sites

  • Ballarat Health Services ( Site 0206)

    Ballarat, Victoria, 3350

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

    Blacktown, New South Wales, 2148

  • MNCCI Port Macquarie Base Hospital ( Site 0200)

    Port Macquarie, New South Wales, 2444

  • Southern Medical Day Care Centre ( Site 0201)

    Wollongong, New South Wales, 2500

Other trials in Australia

Russia4 sites

  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0910)

    Kazan', Tatarstan, Respublika, 420029

  • Blokhin National Medical Oncology ( Site 0902)

    Moscow, Moscow, 115478

  • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0904)

    Saint Petersburg, Sankt-Peterburg, 197758

  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0903)

    Ufa, Baskortostan, Respublika, 450054

Other trials in Russia

South Korea4 sites

  • Chungbuk National University Hospital ( Site 1003)

    Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644

  • National Cancer Center ( Site 1002)

    Goyang-si, Kyonggi-do, 10408

  • Samsung Medical Center ( Site 1001)

    Seoul, Seoul-teukbyeolsi [Seoul], 06351

  • Ulsan University Hospital ( Site 1000)

    Ulsan, Ulsan-Kwangyokshi, 44033

Other trials in South Korea

New Zealand1 site

  • Auckland City Hospital ( Site 0700)

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination With Platinum Doublet Chemotherapy and Radiotherapy for Participants With Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-799)

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).

Being tested
Pembrolizumab 200 mg, Paclitaxel 45 mg/m^2, Carboplatin AUC6, Cisplatin 75 mg/m^2, Pemetrexed 500 mg/m^2
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab 200 mgDrug

    Also called MK-3475

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

  • Paclitaxel 45 mg/m^2Drug

    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.

  • Carboplatin AUC6Drug

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

  • Cisplatin 75 mg/m^2Drug

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

  • Pemetrexed 500 mg/m^2Drug

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

  • Thoracic Radiation Therapy (TRT)Radiation

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

  • Paclitaxel 200 mg/m^2Drug

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

  • Carboplatin AUC2Drug

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

Study groups in NCT03631784
Study groupRoleWhat they receive
Cohort AExperimentalParticipants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
Receives: Drug: Pembrolizumab 200 mg; Drug: Paclitaxel 45 mg/m^2; Drug: Carboplatin AUC6; Radiation: Thoracic Radiation Therapy (TRT); Drug: Paclitaxel 200 mg/m^2; Drug: Carboplatin AUC2
Cohort BExperimentalParticipants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
Receives: Drug: Pembrolizumab 200 mg; Drug: Cisplatin 75 mg/m^2; Drug: Pemetrexed 500 mg/m^2; Radiation: Thoracic Radiation Therapy (TRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Developed Grade 3 or Higher Pneumonitis

    Pneumonitis included the MedDRA preferred terms for radiation pneumonitis are acute interstitial pneumonitis, autoimmune lung disease, interstitial lung disease, pneumonitis, idiopathic pneumonia syndrome, organizing pneumonia, and immune-mediated pneumonitis. As per common terminology criteria for Adverse Events, version 4.0, pneumonitis was graded as follows: Grade (Gr) 1- asymptomatic, clinical or diagnostic observations only; intervention not indicated; Gr 2- symptomatic, medical intervention indicated, limiting instrumental activities of daily living (ADL); Gr 3- severe symptoms; limiting self-care activities of daily living (ADL), oxygen indicated; Gr 4- life-threatening respiratory compromise; urgent intervention indicated (e.g., tracheotomy or intubation); Gr 5- death.

    Measured: Up to approximately 3 years

  2. Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    ORR was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified RECIST 1.1 by blinded independent central review (BICR).

    Measured: Up to approximately 3 years

Secondary outcomes (4)

  1. Progression Free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    PFS was defined as the time from the first dose of study treatment to the date of the first documentation of disease progression, as determined by BICR per RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum, and/or unequivocal progression of existing non-target lesions, and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to approximately 5 1/2 years

  2. Overall Survival (OS)

    OS is defined as the time from enrollment to death due to any cause. OS was estimated and analyzed using the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to approximately 5 1/2 years

  3. Number of Participants Who Experienced an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE was assessed.

    Measured: Up to approximately 1 1/2 years

  4. Number of Participants Who Discontinued From Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed.

    Measured: Up to approximately 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2018
  2. Study start19 Oct 2018
  3. Primary completion18 Oct 2021
  4. Study completion19 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03631784
Sponsor's protocol ID
3475-799
Other IDs
MK-3475-799, 2018-000714-37, 2018
Acronym
KEYNOTE-799
Status last verified
Mar 2025
First submitted
13 Aug 2018
Last updated
25 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Jabbour SK, Lee KH, Frost N, Breder V, Kowalski DM, Pollock T, Levchenko E, Reguart N, Martinez-Marti A, Houghton B, Paoli JB, Safina S, Park K, Komiya T, Sanford A, Boolell V, Liu H, Samkari A, Keller SM, Reck M. Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer: The Phase 2 KEYNOTE-799 Nonrandomized Trial. JAMA Oncol. 2021 Jun 4;7(9):1-9. doi: 10.1001/jamaoncol.2021.2301. Online ahead of print.

    PubMed 34086039

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab 200 mg, Paclitaxel 45 mg/m^2 and Carboplatin AUC6 in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 56 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, France, Germany, United Kingdom, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Developed Grade 3 or Higher Pneumonitis (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03631784, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.

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