protocolSection identificationModule nctId: NCT06311721, orgStudyIdInfo id: 20210033, secondaryIdInfos id: 2023-508336-57, type: EUDRACT_NUMBER, briefTitle: A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2027-10-22, completionDateStruct date: 2027-10-22, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®)., conditionsModule conditions: Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 927, type: ESTIMATED, armsInterventionsModule interventions name: ABP 234, interventions name: Pembrolizumab (US), interventions name: Pembrolizumab (EU), outcomesModule primaryOutcomes measure: Objective response (OR), primaryOutcomes measure: Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234, primaryOutcomes measure: AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234, secondaryOutcomes measure: OR, secondaryOutcomes measure: OR, secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Maximum observed serum concentration following the first dose (Cmax_dose1) of ABP 234, secondaryOutcomes measure: Cmax_dose1 of pembrolizumab (US), secondaryOutcomes measure: Cmax_dose1 of pembrolizumab (EU), secondaryOutcomes measure: Time to maximum concentration following the first dose (tmax_dose1) of ABP 234, secondaryOutcomes measure: Tmax_dose1 of pembrolizumab (US), secondaryOutcomes measure: Tmax_dose1 of pembrolizumab (EU), secondaryOutcomes measure: Maximum observed serum concentration (Cmax) at steady state (Cmax_ss) of ABP 234, secondaryOutcomes measure: Cmax_ss of pembrolizumab (US), secondaryOutcomes measure: Cmax_ss of of pembrolizumab (EU), secondaryOutcomes measure: Time to maximum concentration at steady state (tmax_ss) of ABP 234, secondaryOutcomes measure: Tmax_ss of pembrolizumab (US), secondaryOutcomes measure: Tmax_ss of pembrolizumab (EU), secondaryOutcomes measure: Trough serum concentrations at pre-dose of week 4 (Ctrough_w4) of ABP 234, secondaryOutcomes measure: Ctrough_w4 of pembrolizumab (US), secondaryOutcomes measure: Ctrough_w4 of pembrolizumab (EU), secondaryOutcomes measure: Trough serum concentrations at steady state (Ctrough_ss) at pre-dose of ABP 234, secondaryOutcomes measure: Ctrough_ss at pre-dose of pembrolizumab (US), secondaryOutcomes measure: Ctrough_ss at pre-dose of pembrolizumab (EU), secondaryOutcomes measure: AUC21d of pembrolizumab (US), secondaryOutcomes measure: AUC21d of pembrolizumab (EU), secondaryOutcomes measure: AUCtau_ss of pembrolizumab (US), secondaryOutcomes measure: AUCtau_ss pembrolizumab (EU), secondaryOutcomes measure: Number of participants who experience a Treatment-emergent adverse event, secondaryOutcomes measure: Number of participants who experience a Treatment-emergent serious adverse event, secondaryOutcomes measure: Number of participants who experience a Treatment-emergent adverse event of interest, secondaryOutcomes measure: Number of participants who experience anti-drug antibodies (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False