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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03631784
Recruitment Status : Active, not recruiting
First Posted : August 15, 2018
Results First Posted : November 2, 2022
Last Update Posted : November 2, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Interventions Drug: Pembrolizumab 200 mg
Drug: Paclitaxel 45 mg/m^2
Drug: Carboplatin AUC6
Drug: Cisplatin 75 mg/m^2
Drug: Pemetrexed 500 mg/m^2
Radiation: Thoracic Radiation Therapy (TRT)
Drug: Paclitaxel 200 mg/m^2
Drug: Carboplatin AUC2
Enrollment 217
Recruitment Details Participants with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC), who had received no prior anticancer therapy for their disease were recruited into two cohorts.
Pre-assignment Details  
Arm/Group Title Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
Hide Arm/Group Description Participants 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. Participants 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.
Period Title: Overall Study
Started 112 102
Completed 0 0
Not Completed 112 102
Reason Not Completed
Death             48             28
Lost to Follow-up             1             0
Withdrawal by Subject             0             3
Participants Ongoing             63             71
Arm/Group Title Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin Total
Hide Arm/Group Description Participants 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. Participants 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. Total of all reporting groups
Overall Number of Baseline Participants 112 102 214
Hide Baseline Analysis Population Description
The analysis population consisted of all allocated participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 102 participants 214 participants
65.7  (9.1) 63.1  (9.4) 64.5  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 102 participants 214 participants
Female
36
  32.1%
40
  39.2%
76
  35.5%
Male
76
  67.9%
62
  60.8%
138
  64.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 102 participants 214 participants
Hispanic or Latino
2
   1.8%
3
   2.9%
5
   2.3%
Not Hispanic or Latino
101
  90.2%
84
  82.4%
185
  86.4%
Unknown or Not Reported
9
   8.0%
15
  14.7%
24
  11.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 102 participants 214 participants
American Indian or Alaska Native
1
   0.9%
0
   0.0%
1
   0.5%
Asian
14
  12.5%
11
  10.8%
25
  11.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   0.9%
3
   2.9%
4
   1.9%
White
89
  79.5%
74
  72.5%
163
  76.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
7
   6.3%
14
  13.7%
21
   9.8%
1.Primary Outcome
Title Percentage of Participants Who Developed Grade 3 or Higher Pneumonitis
Hide Description 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.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received at least one dose of study drug.
Arm/Group Title Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
Hide Arm/Group Description:
Participants 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.
Participants 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.
Overall Number of Participants Analyzed 112 102
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of Participants
8.0
(4.3 to 13.6)
6.9
(3.3 to 12.5)
2.Primary Outcome
Title Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Hide Description 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).
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received at least 1 dose of study treatment.
Arm/Group Title Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
Hide Arm/Group Description:
Participants 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.
Participants 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.
Overall Number of Participants Analyzed 112 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
71.4
(62.1 to 79.6)
75.5
(66.0 to 83.5)
3.Secondary Outcome
Title Progression Free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Hide Description 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.
Time Frame Up to approximately 5 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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.
Time Frame Up to approximately 5 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Number of Participants Who Experienced an Adverse Event (AE)
Hide Description 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.
Time Frame Up to approximately 1 1/4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received at least one dose of study drug.
Arm/Group Title Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
Hide Arm/Group Description:
Participants 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.
Participants 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.
Overall Number of Participants Analyzed 112 102
Measure Type: Count of Participants
Unit of Measure: Participants
108
  96.4%
101
  99.0%
6.Secondary Outcome
Title Number of Participants Who Discontinued From Study Treatment Due to an AE
Hide Description 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.
Time Frame Up to approximately 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received at least one dose of study drug.
Arm/Group Title Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
Hide Arm/Group Description:
Participants 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.
Participants 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.
Overall Number of Participants Analyzed 112 102
Measure Type: Count of Participants
Unit of Measure: Participants
48
  42.9%
26
  25.5%
Time Frame For adverse events: Up to ~ 1 1/4 years. All-cause mortality (ACM): Up to ~ 3 years.
Adverse Event Reporting Description All-cause mortality includes all randomized participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
 
Arm/Group Title Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
Hide Arm/Group Description Participants 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. Participants 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.
All-Cause Mortality
Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   48/112 (42.86%)      28/102 (27.45%)    
Hide Serious Adverse Events
Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   66/112 (58.93%)      46/102 (45.10%)    
Blood and lymphatic system disorders     
Anaemia † 1  1/112 (0.89%)  1 3/102 (2.94%)  3
Autoimmune haemolytic anaemia † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Febrile neutropenia † 1  5/112 (4.46%)  5 0/102 (0.00%)  0
Haematotoxicity † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Neutropenia † 1  1/112 (0.89%)  1 1/102 (0.98%)  1
Pancytopenia † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Thrombocytopenia † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Atrial fibrillation † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Cardiac failure † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Cardiac failure acute † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Myocardial ischaemia † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Myocarditis † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Pericardial effusion † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Supraventricular tachycardia † 1  2/112 (1.79%)  2 0/102 (0.00%)  0
Congenital, familial and genetic disorders     
Tracheo-oesophageal fistula † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Endocrine disorders     
Hyperthyroidism † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Hypophysitis † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Hypothyroidism † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Gastrointestinal disorders     
Abdominal pain † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Diarrhoea † 1  2/112 (1.79%)  2 0/102 (0.00%)  0
Dysphagia † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Gastric ulcer † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Gastritis † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Gastrointestinal haemorrhage † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Impaired gastric emptying † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Intestinal obstruction † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Nausea † 1  2/112 (1.79%)  2 1/102 (0.98%)  1
Odynophagia † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Oesophageal perforation † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Oesophagitis † 1  2/112 (1.79%)  2 0/102 (0.00%)  0
Stomatitis † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Vomiting † 1  1/112 (0.89%)  1 1/102 (0.98%)  1
General disorders     
Asthenia † 1  2/112 (1.79%)  2 2/102 (1.96%)  2
Death † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Device related thrombosis † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Fatigue † 1  2/112 (1.79%)  2 0/102 (0.00%)  0
Pyrexia † 1  1/112 (0.89%)  1 7/102 (6.86%)  9
Sudden death † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Drug-induced liver injury † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Hepatitis acute † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Hepatobiliary disease † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Immune system disorders     
Anaphylactic reaction † 1  2/112 (1.79%)  2 0/102 (0.00%)  0
Drug hypersensitivity † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Infections and infestations     
Anal abscess † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Biliary tract infection † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Bronchitis † 1  1/112 (0.89%)  1 1/102 (0.98%)  1
Bronchitis bacterial † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
COVID-19 † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
COVID-19 pneumonia † 1  0/112 (0.00%)  0 2/102 (1.96%)  2
Catheter site infection † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Cellulitis † 1  1/112 (0.89%)  1 1/102 (0.98%)  1
Cystitis † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Device related infection † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Encephalitis † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Infectious pleural effusion † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Infective exacerbation of chronic obstructive airways disease † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Lower respiratory tract infection † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Neutropenic sepsis † 1  2/112 (1.79%)  3 0/102 (0.00%)  0
Orchitis † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Pneumocystis jirovecii pneumonia † 1  0/112 (0.00%)  0 2/102 (1.96%)  2
Pneumonia † 1  14/112 (12.50%)  15 9/102 (8.82%)  11
Pneumonia necrotising † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Pneumonia pneumococcal † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Pyelonephritis † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Respiratory tract infection † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Sepsis † 1  4/112 (3.57%)  5 0/102 (0.00%)  0
Urinary tract infection † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Injury, poisoning and procedural complications     
Radiation oesophagitis † 1  3/112 (2.68%)  3 0/102 (0.00%)  0
Radiation pneumonitis † 1  3/112 (2.68%)  3 1/102 (0.98%)  1
Spinal compression fracture † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Tibia fracture † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Investigations     
Neutrophil count decreased † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Platelet count decreased † 1  1/112 (0.89%)  1 1/102 (0.98%)  1
Metabolism and nutrition disorders     
Dehydration † 1  1/112 (0.89%)  1 2/102 (1.96%)  2
Electrolyte imbalance † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Failure to thrive † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Hyperglycaemia † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Hypophagia † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Type 2 diabetes mellitus † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Musculoskeletal and connective tissue disorders     
Hypertrophic osteoarthropathy † 1  0/112 (0.00%)  0 1/102 (0.98%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Non-Hodgkin's lymphoma † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Nervous system disorders     
Dizziness † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Hypertensive encephalopathy † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Ischaemic stroke † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Metabolic encephalopathy † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Syncope † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Transient ischaemic attack † 1  1/112 (0.89%)  1 1/102 (0.98%)  1
Renal and urinary disorders     
Acute kidney injury † 1  1/112 (0.89%)  1 2/102 (1.96%)  2
Chronic kidney disease † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Prerenal failure † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Respiratory, thoracic and mediastinal disorders     
Atelectasis † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Chronic obstructive pulmonary disease † 1  1/112 (0.89%)  1 1/102 (0.98%)  1
Interstitial lung disease † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Pleural effusion † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Pneumonitis † 1  7/112 (6.25%)  7 5/102 (4.90%)  5
Pneumothorax † 1  1/112 (0.89%)  1 1/102 (0.98%)  1
Pulmonary embolism † 1  1/112 (0.89%)  1 4/102 (3.92%)  4
Pulmonary haemorrhage † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Respiratory failure † 1  1/112 (0.89%)  1 2/102 (1.96%)  2
Skin and subcutaneous tissue disorders     
Rash maculo-papular † 1  2/112 (1.79%)  2 0/102 (0.00%)  0
Toxic epidermal necrolysis † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Vascular disorders     
Arterial occlusive disease † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Deep vein thrombosis † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
Embolism † 1  0/112 (0.00%)  0 1/102 (0.98%)  1
Thrombophlebitis † 1  1/112 (0.89%)  1 0/102 (0.00%)  0
1
Term from vocabulary, MedDRA 24.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   106/112 (94.64%)      100/102 (98.04%)    
Blood and lymphatic system disorders     
Anaemia † 1  43/112 (38.39%)  52 33/102 (32.35%)  40
Leukopenia † 1  15/112 (13.39%)  29 8/102 (7.84%)  11
Lymphopenia † 1  11/112 (9.82%)  13 12/102 (11.76%)  16
Neutropenia † 1  32/112 (28.57%)  50 24/102 (23.53%)  31
Thrombocytopenia † 1  17/112 (15.18%)  22 3/102 (2.94%)  3
Cardiac disorders     
Tachycardia † 1  8/112 (7.14%)  9 3/102 (2.94%)  3
Ear and labyrinth disorders     
Tinnitus † 1  1/112 (0.89%)  1 11/102 (10.78%)  13
Vertigo † 1  6/112 (5.36%)  6 3/102 (2.94%)  3
Endocrine disorders     
Hyperthyroidism † 1  9/112 (8.04%)  9 8/102 (7.84%)  9
Hypothyroidism † 1  18/112 (16.07%)  19 15/102 (14.71%)  16
Gastrointestinal disorders     
Abdominal pain † 1  8/112 (7.14%)  8 6/102 (5.88%)  7
Abdominal pain upper † 1  3/112 (2.68%)  4 7/102 (6.86%)  7
Constipation † 1  24/112 (21.43%)  28 27/102 (26.47%)  32
Diarrhoea † 1  27/112 (24.11%)  37 22/102 (21.57%)  27
Dyspepsia † 1  15/112 (13.39%)  17 7/102 (6.86%)  9
Dysphagia † 1  27/112 (24.11%)  31 16/102 (15.69%)  16
Gastrooesophageal reflux disease † 1  5/112 (4.46%)  5 6/102 (5.88%)  6
Nausea † 1  28/112 (25.00%)  36 53/102 (51.96%)  77
Odynophagia † 1  11/112 (9.82%)  14 5/102 (4.90%)  5
Oesophagitis † 1  17/112 (15.18%)  20 24/102 (23.53%)  25
Stomatitis † 1  7/112 (6.25%)  8 6/102 (5.88%)  7
Vomiting † 1  10/112 (8.93%)  11 20/102 (19.61%)  23
General disorders     
Asthenia † 1  19/112 (16.96%)  25 41/102 (40.20%)  60
Chest pain † 1  7/112 (6.25%)  7 10/102 (9.80%)  12
Chills † 1  6/112 (5.36%)  6 3/102 (2.94%)  3
Fatigue † 1  39/112 (34.82%)  49 33/102 (32.35%)  38
Mucosal inflammation † 1  6/112 (5.36%)  6 10/102 (9.80%)  10
Pyrexia † 1  22/112 (19.64%)  28 12/102 (11.76%)  13
Infections and infestations     
Pneumonia † 1  12/112 (10.71%)  14 5/102 (4.90%)  5
Upper respiratory tract infection † 1  8/112 (7.14%)  9 5/102 (4.90%)  5
Urinary tract infection † 1  7/112 (6.25%)  8 2/102 (1.96%)  2
Injury, poisoning and procedural complications     
Radiation oesophagitis † 1  13/112 (11.61%)  13 14/102 (13.73%)  15
Radiation pneumonitis † 1  17/112 (15.18%)  17 12/102 (11.76%)  12
Radiation skin injury † 1  5/112 (4.46%)  5 8/102 (7.84%)  8
Investigations     
Alanine aminotransferase increased † 1  8/112 (7.14%)  9 8/102 (7.84%)  9
Aspartate aminotransferase increased † 1  8/112 (7.14%)  8 4/102 (3.92%)  6
Blood creatinine increased † 1  6/112 (5.36%)  7 13/102 (12.75%)  17
Blood urea increased † 1  3/112 (2.68%)  3 7/102 (6.86%)  9
Lymphocyte count decreased † 1  10/112 (8.93%)  16 8/102 (7.84%)  12
Neutrophil count decreased † 1  20/112 (17.86%)  24 13/102 (12.75%)  15
Platelet count decreased † 1  15/112 (13.39%)  18 9/102 (8.82%)  15
Weight decreased † 1  16/112 (14.29%)  16 14/102 (13.73%)  14
White blood cell count decreased † 1  11/112 (9.82%)  17 11/102 (10.78%)  19
Metabolism and nutrition disorders     
Decreased appetite † 1  24/112 (21.43%)  29 30/102 (29.41%)  34
Dehydration † 1  5/112 (4.46%)  6 6/102 (5.88%)  7
Hyperglycaemia † 1  9/112 (8.04%)  13 6/102 (5.88%)  11
Hypoalbuminaemia † 1  6/112 (5.36%)  8 2/102 (1.96%)  2
Hypokalaemia † 1  9/112 (8.04%)  11 6/102 (5.88%)  8
Hyponatraemia † 1  10/112 (8.93%)  15 3/102 (2.94%)  5
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  17/112 (15.18%)  22 11/102 (10.78%)  11
Back pain † 1  6/112 (5.36%)  8 5/102 (4.90%)  7
Musculoskeletal chest pain † 1  6/112 (5.36%)  8 3/102 (2.94%)  3
Myalgia † 1  10/112 (8.93%)  13 8/102 (7.84%)  9
Nervous system disorders     
Dizziness † 1  9/112 (8.04%)  11 8/102 (7.84%)  10
Dysgeusia † 1  10/112 (8.93%)  11 8/102 (7.84%)  8
Headache † 1  9/112 (8.04%)  9 13/102 (12.75%)  18
Neuropathy peripheral † 1  15/112 (13.39%)  15 5/102 (4.90%)  5
Paraesthesia † 1  6/112 (5.36%)  7 4/102 (3.92%)  4
Peripheral sensory neuropathy † 1  12/112 (10.71%)  13 1/102 (0.98%)  1
Psychiatric disorders     
Insomnia † 1  18/112 (16.07%)  21 7/102 (6.86%)  8
Respiratory, thoracic and mediastinal disorders     
Cough † 1  31/112 (27.68%)  36 29/102 (28.43%)  37
Dyspnoea † 1  24/112 (21.43%)  28 18/102 (17.65%)  19
Oropharyngeal pain † 1  2/112 (1.79%)  2 8/102 (7.84%)  8
Pleural effusion † 1  8/112 (7.14%)  8 2/102 (1.96%)  2
Pneumonitis † 1  16/112 (14.29%)  19 17/102 (16.67%)  19
Productive cough † 1  8/112 (7.14%)  8 9/102 (8.82%)  9
Skin and subcutaneous tissue disorders     
Alopecia † 1  35/112 (31.25%)  35 6/102 (5.88%)  6
Pruritus † 1  15/112 (13.39%)  19 16/102 (15.69%)  17
Rash † 1  22/112 (19.64%)  27 14/102 (13.73%)  15
Rash maculo-papular † 1  6/112 (5.36%)  6 2/102 (1.96%)  2
Vascular disorders     
Hypertension † 1  6/112 (5.36%)  6 5/102 (4.90%)  7
Hypotension † 1  11/112 (9.82%)  11 6/102 (5.88%)  7
1
Term from vocabulary, MedDRA 24.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Results Point of Contact
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Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Publications of Results:
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.
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT03631784    
Other Study ID Numbers: 3475-799
MK-3475-799 ( Other Identifier: Merck Protocol Number )
2018-000714-37 ( EudraCT Number )
First Submitted: August 13, 2018
First Posted: August 15, 2018
Results First Submitted: October 6, 2022
Results First Posted: November 2, 2022
Last Update Posted: November 2, 2022