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NCT06449209 · ClinicalTrials.gov registry record · Phase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
A Phase 2 study of Small-cell Lung Cancer and Extensive-stage Small-cell Lung Cancer, sponsored by BioNTech SE.
- Active
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 20
- Study locations
NCT06449209: Active Phase 2 study of Small-cell Lung Cancer and Extensive-stage Small-cell Lung Cancer, sponsored by BioNTech SE.
NCT06449209 is a Phase 2 study of Small-cell Lung Cancer and Extensive-stage Small-cell Lung Cancer that is active but no longer recruiting, run by BioNTech SE. The registered enrollment target is 110 participants, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06449209, a Phase 2 study of Small-cell Lung Cancer and Extensive-stage Small-cell Lung Cancer, is active but no longer recruiting, sponsored by BioNTech SE.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
In the combination treatment regimen according to the (US) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). By treatment arm and overall.
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 |
What the registry record for NCT06449209 still lists
NCT06449209 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (52% lower).
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.
NCT06449209 names 20 study sites across 16 states, led by Florida, North Carolina, Other.
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.
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).
Who is sponsoring clinical trial NCT06449209?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06449209's enrollment target sits among peer trials
110 34th of 79 higher than 46 of 79 other Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small-cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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