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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
621
Intravenous infusion
Intravenous infusion
Intravenous infusion and capsules
Overall survival (OS)
OS defined as the time from randomization to death from any cause.
Time frame: Up to approximately 46 months
Progression-free survival (PFS)
PFS defined as the time from randomization to first objective tumor progression (progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]), or death from any cause, whichever occurs first.
Time frame: Up to approximately 46 months
Objective response rate (ORR)
ORR defined as the proportion of participants in whom a complete response (CR) or partial response (PR) (based on investigator's assessment per RECIST v1.1) is observed as best overall response with confirmation.
Time frame: Up to approximately 46 months
Duration of response (DOR)
DOR defined as the time from onset of objective response (confirmed CR or PR based on investigator's assessment per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first.
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
TEAEs graded according to (US) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
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Intravenous infusion
Clermont Oncology Center
Clermont, Florida, United States
TERMINATEDCancer Care Centers of Brevard, Inc
Palm Bay, Florida, United States
RECRUITINGIllinois Cancer Specialists
Niles, Illinois, United States
RECRUITINGFort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, United States
RECRUITINGMcFarland Clinic
Ames, Iowa, United States
RECRUITINGHelen G. Nassif Community Cancer Center
Cedar Rapids, Iowa, United States
RECRUITINGBaptist Health Hardin Cancer Center
Elizabethtown, Kentucky, United States
RECRUITINGFrederick Health Hospital- James M Stockman Cancer Institute
Frederick, Maryland, United States
RECRUITINGBeth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center
Burlington, Massachusetts, United States
RECRUITINGBaptist Cancer Center
Southaven, Mississippi, United States
RECRUITING...and 128 more locations
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)
Global health status/QoL scale ranges in score from 0 to 100 with a high scale score representing a higher response level (e.g., high score for global health status/QoL is high QoL: high score for symptom scale/item is high symptomatology or problems).
Time frame: Up to approximately 46 months
Change from baseline in EORTC QLQ-C30 physical functioning
Physical functioning scale ranges in score from 0 to 100 with a high scale score representing a higher response level (e.g., high score for functional scale is high/healthy level of 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)
Multi-item coughing scale ranges in score from 0 to 100 with a high score representing a high level of symptomatology or problems.
Time frame: Up to approximately 46 months
Change from baseline in shortness of breath scale of the EORTC QLQ-LC29
Multi-item shortness of breath scale ranges in score from 0 to 100 with a high score representing a high level of symptomatology or problems.
Time frame: Up to approximately 46 months
Change from baseline in coughed up blood item of the EORTC QLQ-LC29
Single item coughing up blood ranges in score from 0 to 100 with a high score representing a high level of symptomatology or problems.
Time frame: Up to approximately 46 months
Change from baseline in Functional Assessment of Cancer Therapy-General overall bother item (FACT-GP5).
The FACT-G - Item GP5 (Version 4) is a single-item summary measure of the overall impact of treatment toxicity, based upon its association with the number and degree of AEs in clinical studies, rated on a 5-point Likert scale ("not at all" to "very much") with a recall period of past 7 days. A high score represents high level of problems.
Time frame: Up to approximately 46 months