Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
18 Years and older, Male and Female
BNT327-03 (primary)
NCI-2025-02318
2024-515765-34-00
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).
Objectives
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.
Eligibility
- 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-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.
- Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic and organ function as defined in the protocol.
Treatment Sites in Georgia
1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com
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