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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 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.

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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.

Conditions Studied

Small-cell Lung Cancer Extensive-stage Small-cell Lung Cancer

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

FieldValue
Enrollment Target 110 participants
Start Date 2024-08-05
Est. Completion 2028-05
Phase Phase 2

Sponsor

BioNTech SE

53 total trials

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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, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (52% lower). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.