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

COMPLETEDPHASE2

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

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)

NCT03631784•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+12 more criteria

Locations (56)

St Joseph Heritage Healthcare ( Site 1403)

Santa Rosa, California, United States

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

Key Dates

Start Date

October 19, 2018

Primary Completion Date

October 18, 2021

Completion Date

March 19, 2024

Last Updated

March 25, 2025

Enrollment

216

ACTUAL participants

Conditions

Non-small Cell Lung Cancer

Interventions

Pembrolizumab 200 mg

DRUG

Paclitaxel 45 mg/m^2

DRUG

Carboplatin AUC6

DRUG

Cisplatin 75 mg/m^2

DRUG

Pemetrexed 500 mg/m^2

DRUG

Thoracic Radiation Therapy (TRT)

RADIATION

Paclitaxel 200 mg/m^2

DRUG

Carboplatin AUC2

DRUG

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)