A Phase III, Multisite, Double-blinded Randomized Trial of BNT327 in Combination With Chemotherapy (Etoposide/Carboplatin) Compared to Atezolizumab in Combination With Chemotherapy (Etoposide/Carboplatin) in Participants With First-line Extensive-stage Small-cell Lung Cancer
Summary
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).
Detailed description
There are two stages in this study: Stage 1 will have two treatment arms and one control arm, and Stage 2 will have a treatment arm and a control arm. The control arms in Stages 1 and 2 are the same. Each stage of the study consists of a screening period (up to 21 days), an induction period followed by a maintenance period (until confirmed disease progression, intolerable toxicity, participant withdrawal, study termination or up to 2 years \[whichever occurs first\]), and a follow-up (FU) period for all participants (2 safety FU visits and survival FU visits). In Stage 1, eligible participants will be randomized (1:1:1) to the arms. In Stage 2, participants will then be randomized (1:1) to the arms. The randomization will be stratified based on the following factors: 1. Brain or liver metastases per investigator assessment (presence versus absence); 2. Smoking status (smoker versus never-smoker); and 3. Geography. Participants will be allowed to switch to cisplatin if carboplatin is not tolerated at the investigator's discretion.
Arms & interventions
- DrugPumitamig
Intravenous infusion
- DrugAtezolizumab
Intravenous infusion
- DrugEtoposide
Intravenous infusion and capsules
- DrugCarboplatin (or cisplatin if carboplatin is not tolerated)
Intravenous infusion
Outcome measures
Primary
Overall survival (OS)
OS defined as the time from randomization to death from any cause.
Time frame: Up to approximately 46 months
Secondary
Progression-free survival (PFS)
Time frame: Up to approximately 46 months
Objective response rate (ORR)
Time frame: Up to approximately 46 months
Duration of response (DOR)
Time frame: Up to approximately 46 months
PFS rate based on investigator's assessment
Time frame: At 6, 12, and 18 months
OS rate
Time frame: At 6, 12, 18, and 24 months
Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship
Time frame: From the first dose of study treatment to the 90-Day Follow-up Visit
Occurrence of dose delay, infusion interruption and discontinuation of study treatment due to TEAEs (including related TEAEs)
Time frame: From first to last dose of study treatment, i.e., up to 2 years
Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Core 30 questionnaire (QLQ-C30) Global Health status/Quality-of-Life score (Items 29 and 30)
Time frame: Up to approximately 46 months
Change from baseline in EORTC QLQ-C30 physical functioning
Time frame: Up to approximately 46 months
Change from baseline in coughing scale of the EORTC Quality-of-Life-Lung cancer 29 questionnaire (QLQ-LC29)
Time frame: Up to approximately 46 months
Change from baseline in shortness of breath scale of the EORTC QLQ-LC29
Time frame: Up to approximately 46 months
Change from baseline in coughed up blood item of the EORTC QLQ-LC29
Time frame: Up to approximately 46 months
Change from baseline in Functional Assessment of Cancer Therapy-General overall bother item (FACT-GP5).
Time frame: Up to approximately 46 months
Eligibility criteria
Study locations (32)
ACRC Arizona Clinical Research Center
Tucson, Arizona, 85715
Clermont Oncology Center
Clermont, Florida, 34711
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, 32901
Illinois Cancer Specialists
Niles, Illinois, 60714
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, 46804
McFarland Clinic
Ames, Iowa, 50010
Helen G. Nassif Community Cancer Center
Cedar Rapids, Iowa, 52403
Baptist Health Hardin Cancer Center
Elizabethtown, Kentucky, 42701
Frederick Health Hospital- James M Stockman Cancer Institute
Frederick, Maryland, 21704
Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
Baptist Cancer Center
Southaven, Mississippi, 38671
Washington University School of Medicine
St Louis, Missouri, 63110
Nebraska Hematology-Oncology (NHO)
Lincoln, Nebraska, 68506
Cornell University - NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065
White Plains Hospital
White Plains, New York, 10601
Cleveland Clinic - Akron General Hematology & Oncology
Akron, Ohio, 44302
Cleveland Clinic Mercy Hospital Cancer Center
Canton, Ohio, 44708
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion
Cleveland, Ohio, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-0001
Kettering Medical Center
Kettering, Ohio, 45429
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, 44124
St. Luke's Physician Group - St. Luke's Cancer Care Associates
Fountain Hill, Pennsylvania, 18015-1153
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Millennium Research and Clinical Development, LLC
Houston, Texas, 77090
Texas Oncology Cancer Center
Sugar Land, Texas, 77479
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, 22408
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298
Shenandoah Oncology
Winchester, Virginia, 22601