A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

Part of paid clinical trials in La Mesa, California.

Sponsor
AstraZeneca
Study ID
NCT06868277
Phase
PHASE3
Status
Recruiting

Conditions

  • Carcinoma, Non-Small Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rilvegostomig — BIOLOGICAL
    Administered intravenously (IV) on Day 1 of each 21-day cycle
  • Pembrolizumab — BIOLOGICAL
    Administered intravenously (IV) on Day 1 of each 21-day cycle

Study Details

The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.

Key Dates

Start date
Apr 10, 2025
Status verified
May 2026
Primary completion
Jan 17, 2030
Completion
Dec 2, 2030

Study Design

Enrollment
830 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Drug: rilvegostomig
  • Active Comparator: Arm B
    Drug: Pembrolizumab

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]

Central Contacts

Locations (37)

FacilityCityStateZIPSite coordinators
Research SiteLa MesaCalifornia91942-
Research SiteLos AlamitosCalifornia90720-
Research SiteFarmingtonConnecticut06030-
Research SiteNewarkDelaware19713-
Research SiteBay PinesFlorida33744-
Research SiteClearwaterFlorida33756-
Research SiteSt. PetersburgFlorida33705-
Research SiteMariettaGeorgia30060-
Research SiteChicagoIllinois60612-
Research SiteDecaturIllinois62526-
Research SiteDes MoinesIowa50309-
Research SiteWaterlooIowa50702-
Research SiteLeawoodKansas66209-
Research SiteLexingtonKentucky40536-
Research SiteOwensboroKentucky42303-
Research SiteBethesdaMaryland20817-
Research SiteFrederickMaryland21702-
Research SiteSilver SpringMaryland20910-
Research SiteTowsonMaryland21204-
Research SiteSaginawMichigan48602-
Research SiteBridgetonMissouri63044-
Research SiteLincolnNebraska68506-
Research SiteParamusNew Jersey07652-
Research SiteBuffaloNew York14215-
Research SiteEast SyracuseNew York13057-
Research SiteFresh MeadowsNew York11366-
Research SiteRochesterNew York14642-
Research SiteWestburyNew York11590-
Research SiteCantonOhio44718-
Research SiteFountain HillPennsylvania18015-
Research SiteKittanningPennsylvania16201-
Research SitePhiladelphiaPennsylvania19104-
Research SiteRound RockTexas78665-
Research SiteAberdeenWashington98520-
Research SiteRentonWashington98055-
Research SiteCharlestonWest Virginia25304-
Research SiteMorgantownWest Virginia26506-

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