Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
NCT06449209 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase II, multi-site, open-label, parallel group study in participants with untreated extended-stage small-cell lung cancer (ES-SCLC) (Cohort 1) or small-cell lung cancer (SCLC) which has progressed on first- or second-line treatment (Cohort 2 and Cohort 3). This study will assess the safety, efficacy, and pharmacokinetics (PK) of BNT327.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Etoposide
- DRUG BNT327 Dose Level 1 (DL1)
- DRUG BNT327 Dose Level 2 (DL2)
Study Locations (20)
Florida
- Clermont Oncology Center — Clermont
- Hematology Oncology Associates of Treasure Coast — Port Saint Lucie
- Tallahassee Memorial Physician Partners - Cancer & Hematology Specialists — Tallahassee
North Carolina
- Haywood Infusion Center — Clyde
- FirstHealth Outpatient Cancer Center — Pinehurst
Other
- Lyell McEwin Hospital — Adelaide
- St. Vincent's Hospital — Fitzroy
Alaska
- Alaska Oncology and Hematology, LLC — Anchorage
California
- Valkyrie Clinical Trials — Los Angeles
Illinois
- Carle Foundation Hospital d/b/a Carle Cancer Center — Urbana
Indiana
- Fort Wayne Medical Oncology and Hematology, Inc — Fort Wayne
Kentucky
- University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center) — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2024-08-05 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06449209
The ClinicalTrials.gov registry entry for NCT06449209 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06449209 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Florida, North Carolina, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06449209 about?
NCT06449209 is a clinical study titled "Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy". This is a Phase II, multi-site, open-label, parallel group study in participants with untreated extended-stage small-cell lung cancer (ES-SCLC) (Cohort 1) or small-cell lung cancer (SCLC) which has progressed on first- or second-line treatment (Cohort 2 and Cohort 3). This study will assess the safe...
What is the current status of trial NCT06449209?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2024-08-05. Estimated completion is 2028-05.
What conditions does trial NCT06449209 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer, Extensive-stage Small-cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06449209?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Etoposide (DRUG), BNT327 Dose Level 1 (DL1) (DRUG), BNT327 Dose Level 2 (DL2) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06449209?
This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06449209 being conducted?
This trial has 20 study locations across Alaska, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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