18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Developed Grade 3 or Higher PneumonitisPrimary· Up to approximately 3 years
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
Group
Value
95% CI
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
8.0
4.3 – 13.6
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
6.9
3.3 – 12.5
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)Primary· Up to approximately 3 years
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).
Group
Value
95% CI
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
71.4
62.1 – 79.6
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
75.5
66.0 – 83.5
Progression Free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)Secondary· Up to approximately 5 1/2 years
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 (Ka
Group
Value
95% CI
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
29.0
16.6 – 48.5
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
45.3
17.9 – NA
Overall Survival (OS)Secondary· Up to approximately 5 1/2 years
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.
Group
Value
95% CI
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
35.6
26.1 – 44.2
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
56.7
41.1 – NA
Number of Participants Who Experienced an Adverse Event (AE)Secondary· Up to approximately 1 1/2 years
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.
Group
Value
95% CI
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
108
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
101
Number of Participants Who Discontinued From Study Treatment Due to an AESecondary· Up to approximately 1 year
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.
Group
Value
95% CI
Pembrolizumab + cCRT + Paclitaxel + Carboplatin
48
Pembrolizumab + cCRT + Pemetrexed + Cisplatin
26
Adverse events — posted to ClinicalTrials.gov
Time frame: For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04624204 — Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib
· Phase 3
· active not recruiting
NCT03765918 — Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head
· Phase 3
· active not recruiting
NCT02861573 — Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/K
· Phase 1, PHASE2
· recruiting
NCT03950674 — Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metast
· Phase 3
· completed
NCT02578680 — Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metast
· Phase 3
· completed
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Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005)
· Phase 2
· not yet recruiting
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· Phase 1, PHASE2
· recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527
· Phase 1
· not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M
· Phase 3
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 25 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03631784.