Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
BioNTech SE
Study ID
NCT06712355
Phase
PHASE3
Status
Recruiting
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Conditions

  • Extensive-stage Small-cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Pumitamig — DRUG
    Intravenous infusion
  • Atezolizumab — DRUG
    Intravenous infusion
  • Etoposide — DRUG
    Intravenous infusion and capsules
  • Carboplatin (or cisplatin if carboplatin is not tolerated) — DRUG
    Intravenous infusion

Study Details

This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).

Key Dates

Start date
Feb 3, 2025
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Mar 31, 2029

Study Design

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

Arms

  • Active Comparator: Stage 1 Control Arm - Atezolizumab + Etoposide + Carboplatin
  • Experimental: Stage 1 Treatment Arm 1 - Pumitamig Dose 1 + Etoposide + Carboplatin
  • Experimental: Stage 1 Treatment Arm 2 - Pumitamig Dose 2 + Etoposide + Carboplatin
  • Active Comparator: Stage 2 Control Arm - Atezolizumab + Etoposide + Carboplatin
  • Experimental: Stage 2 Treatment Arm - Pumitamig Dose 3 + Etoposide + Carboplatin

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Up to approximately 46 months ]

Central Contacts

Locations (32)

FacilityCityStateZIPSite coordinators
ACRC Arizona Clinical Research CenterTucsonArizona85715-
Clermont Oncology CenterClermontFlorida34711-
Cancer Care Centers of Brevard, IncPalm BayFlorida32901-
Illinois Cancer SpecialistsNilesIllinois60714-
Fort Wayne Medical Oncology and Hematology, IncFort WayneIndiana46804-
McFarland ClinicAmesIowa50010-
Helen G. Nassif Community Cancer CenterCedar RapidsIowa52403-
Baptist Health Hardin Cancer CenterElizabethtownKentucky42701-
Frederick Health Hospital- James M Stockman Cancer InstituteFrederickMaryland21704-
Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical CenterBurlingtonMassachusetts01805-
Baptist Cancer CenterSouthavenMississippi38671-
Washington University School of MedicineSt LouisMissouri63110-
Nebraska Hematology-Oncology (NHO)LincolnNebraska68506-
Cornell University - NewYork-Presbyterian/Weill Cornell Medical CenterNew YorkNew York10065-
White Plains HospitalWhite PlainsNew York10601-
Cleveland Clinic - Akron General Hematology & OncologyAkronOhio44302-
Cleveland Clinic Mercy Hospital Cancer CenterCantonOhio44708-
The Christ Hospital Cancer CenterCincinnatiOhio45219-
Cleveland Clinic FoundationClevelandOhio44195-0001-
The Cleveland Clinic Cancer Center at Fairview Hospital, Moll PavilionClevelandOhio44111-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Kettering Medical CenterKetteringOhio45429-
Cleveland Clinic - Hillcrest HospitalMayfield HeightsOhio44124-
St. Luke's Physician Group - St. Luke's Cancer Care AssociatesFountain HillPennsylvania18015-1153-
University of Tennessee Medical CenterKnoxvilleTennessee37920-
Millennium Research and Clinical Development, LLCHoustonTexas77090-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Texas Oncology Cancer CenterSugar LandTexas77479-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Hematology Oncology Associates of Fredericksburg, Inc.FredericksburgVirginia22408-
Virginia Commonwealth University School of MedicineRichmondVirginia23298-
Shenandoah OncologyWinchesterVirginia22601-

Find similar trials in Tucson, AZ

By research site
ACRC Arizona Clinical Research Center· Tucson, AZClermont Oncology Center· Clermont, FLCancer Care Centers of Brevard, Inc· Palm Bay, FLIllinois Cancer Specialists· Niles, ILFort Wayne Medical Oncology and Hematology, Inc· Fort Wayne, INMcFarland Clinic· Ames, IA

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