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

BioNTech SE

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).

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 participan…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Have histologically or cytologically confirmed ES-SCLC (using the AJCC \[American Joint Committee on Cancer\] tumor node metastasis staging system combined with Veterans Administration Lung Study Group \[VALG\]'s two stage classification scheme). For AJCC tumor node metastasis staging system: AJCC 8th edition stage IV (T any, N any, M1a/b/c), or T3\~4 for multiple lung nodules or tumor/nodule volume that cannot be encompassed in a tolerable radiotherapy plan. * Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited…

Interventions

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

Locations (138)

Clermont Oncology Center
Clermont, Florida
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida
Illinois Cancer Specialists
Niles, Illinois
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana
McFarland Clinic
Ames, Iowa
Helen G. Nassif Community Cancer Center
Cedar Rapids, Iowa