First-line treatment of participants with metastatic nonsmall cell lung cancer
Conditions
Brief summary
Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose, Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State
Detailed description
Maximum Serum Concentration (Cmax) of Pembrolizumab Measured After the First Dose, Trough Concentration (Ctrough) of Pembrolizumab Measured After the First Dose, Area Under the Curve (AUC) of Pembrolizumab Measured at Steady State, Maximum Serum Concentration (Cmax) of Pembrolizumab Measured at Steady State, Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs) for Pembrolizumab, Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), Progression-free Survival (PFS) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), Overall Survival (OS), Duration of Response (DOR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), Number of Participants Who Experienced at Least One Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE), Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score-Items 29 and 30, Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Physical Functioning Score-Items 1 to 5, Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Role Functioning Score-Items 6 and 7
Interventions
DRUGPACLITAXEL ALBUMIN-BOUND
DRUGCISPLATIN
DRUGPEMETREXED
DRUGMK-3475A
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGPaclitaxel EVER Pharma 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGPEGFILGRASTIM
DRUGALIMTA 500 mg powder for concentrate for solution for infusion
DRUGFILGRASTIM
DRUGPACLITAXEL
DRUGCARBOPLATIN
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose, Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Serum Concentration (Cmax) of Pembrolizumab Measured After the First Dose, Trough Concentration (Ctrough) of Pembrolizumab Measured After the First Dose, Area Under the Curve (AUC) of Pembrolizumab Measured at Steady State, Maximum Serum Concentration (Cmax) of Pembrolizumab Measured at Steady State, Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs) for Pembrolizumab, Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), Progression-free Survival (PFS) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), Overall Survival (OS), Duration of Response (DOR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), Number of Participants Who Experienced at Least One Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE), Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Qual | — |
Countries
France, Hungary, Poland, Romania, Spain
Outcome results
None listed