Pembrolizumab
DrugPembrolizumab administered intravenously every 3 weeks.
Other names: MK-3475
NCT Number: NCT03322566
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2
Blacktown Hospital, Blacktown, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pembrolizumab administered intravenously every 3 weeks.
Other names: MK-3475
Epacadostat administered orally twice daily.
Other names: INCB024360
Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.
Matching placebo administered orally twice daily.
Time frame: Assessed every 12 weeks up to 24 months
ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).
Time frame: Up to 24 months
Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.
Time frame: Up to 24 months
Defined as the time from randomization to death due to any cause.
Time frame: Up to 24 months
Defined as the time from the earliest date of qualifying response until earliest date of disease progression, per RECIST v1.1, or death from any cause, whichever comes first.
Time frame: Up to 25 months
An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to 25 months
An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of any study drug, whether or not considered related to the study drug.
Incyte Corporation
Industry
A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03322540
Bronchial Neoplasms, Carcinoma, Bronchogenic
Anaheim, California, United States
View Trial DetailsNCT04939324
Bronchial Neoplasms, Carcinoma, Bronchogenic
Limoges, France
View Trial DetailsNCT04262856
Bronchial Neoplasms, Carcinoma, Bronchogenic
Birmingham, Alabama, United States
View Trial DetailsNCT01421953
Bronchial Neoplasms, Carcinoma, Bronchogenic
Bordeaux, France
View Trial Details