A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

Part of paid clinical trials in Santa Barbara, California.

Sponsor
Amgen
Study ID
NCT05920356
Phase
PHASE3
Status
Recruiting
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Conditions

  • Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Sotorasib — DRUG
    Oral administration
  • Pembrolizumab — DRUG
    Intravenous administration

Study Details

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Key Dates

Start date
Nov 16, 2023
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 29, 2032

Study Design

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

Arms

  • Experimental: Sotorasib combined with carboplatin and pemetrexed
    Sotorasib administered in combination with carboplatin and pemetrexed.
  • Active Comparator: Pembrolizumab combined with carboplatin and pemetrexed
    Pembrolizumab administered in combination with carboplatin and pemetrexed.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Approximately 2.5 years ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
Sansum ClinicSanta BarbaraCalifornia93105-
Medical Oncology Hematology Consultants Helen F Graham Cancer CenterNewarkDelaware19713-
University of Illinois ChicagoChicagoIllinois60612-
Illinois Cancer SpecialistsNilesIllinois60714-
Norton Cancer Institute - BrownsboroLouisvilleKentucky40241-
Reliant Medical Group IncWorcesterMassachusetts01606-
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87131-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Messino Cancer Centers AshevilleAshevilleNorth Carolina28806-
Duke University Medical CenterDurhamNorth Carolina27710-
FirstHealth Cancer CenterPinehurstNorth Carolina28374-
Alliance Cancer Specialists - MediaMediaPennsylvania19063-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Regional One HealthMemphisTennessee38103-
Sarah Cannon Research InstituteNashvilleTennessee37203-
United States Oncology Regulatory Affairs Corporate OfficeNashvilleTennessee37203-
Oncology Consultants PAHoustonTexas77030-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
US Oncology Research Investigational Products CenterIrvingTexas75063-
Vista Oncology Inc PSOlympiaWashington98506-
MercyhealthJanesvilleWisconsin53548-

Find similar trials in Santa Barbara, CA

By research site
Sansum Clinic· Santa Barbara, CAMedical Oncology Hematology Consultants Helen F Graham Cancer Center· Newark, DEUniversity of Illinois Chicago· Chicago, ILIllinois Cancer Specialists· Niles, ILNorton Cancer Institute - Brownsboro· Louisville, KYReliant Medical Group Inc· Worcester, MA

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