Study on the Safety and Effectiveness of BNT327 with Chemotherapy for Untreated Small-cell Lung Cancer
Sponsor: BioNTech SE
ClinicalTrials ID:NCT06712355
This clinical trial is testing a new treatment, BNT327, combined with chemotherapy, to see if it is safe and effective for patients with extensive-stage small-cell lung cancer (ES-SCLC) who have not received prior treatment.
Patient Parameters
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Program Overview
This study is a Phase III trial conducted at multiple sites to compare the new treatment BNT327 combined with chemotherapy (etoposide and carboplatin) against the standard treatment of atezolizumab with the same chemotherapy for patients with extensive-stage small-cell lung cancer (ES-SCLC) who have not been treated before.
Description
The study includes several stages: a screening period lasting up to 21 days, an induction period followed by a maintenance period until the cancer progresses, side effects become too severe, the patient chooses to leave, the trial ends, or up to 2 years, whichever comes first. After treatment, there will be follow-up visits to monitor safety and survival.
Patients will be randomly assigned to one of three treatment groups. Once one group is full, patients will be assigned to the remaining two groups. The assignment will consider factors like whether the cancer has spread to the brain or liver and the patient's location.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with extensive-stage small-cell lung cancer (ES-SCLC) using specific medical criteria.
- Have not received any prior systemic treatment for ES-SCLC. If previously treated for limited-stage SCLC, there must be a 6-month gap after the last treatment before joining this study.
- Have at least one measurable tumor that can be tracked during the study.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate blood cell counts and organ function.
Exclusion Criteria
- Have a type of small-cell lung cancer with mixed cell types.
- Have received certain treatments or drugs within specific timeframes before starting the trial treatment, such as recent radiation or certain medications.
- Have previously been treated with specific types of cancer drugs, like PD(L)-1/VEGF bispecific antibodies.
- Have used high-dose corticosteroids recently, except for certain short-term uses.
- Have untreated or unstable brain metastases or certain other brain conditions.
- Have serious wounds or fractures that are not healing.
- Have significant bleeding disorders or recent serious bleeding events.
- Have certain conditions like superior vena cava syndrome or spinal cord compression.
Note: Other specific criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Clermont Oncology Center | 34711 | Clermont | Florida |
| Fort Wayne Medical Oncology and Hematology, Inc | 46804 | Fort Wayne | Indiana |
| Nebraska Hematology-Oncology (NHO) | 68506 | Lincoln | Nebraska |
| Millennium Research and Clinical Development, LLC | 77090 | Houston | Texas |
| Hematology Oncology Associates of Fredericksburg, Inc. | 22408 | Fredericksburg | Virginia |
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