ACTIVE_NOT_RECRUITING

Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II, Multi-site, Open-label, Parallel Group Trial of BNT327 in Combination With Chemotherapy for Participants With Untreated Extensive-stage Small-cell Lung Cancer and Participants With Previously Treated Small-cell Lung Cancer

Quick Facts

Study Start:2024-08-05
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06449209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

BioNTech Responsible Person
STUDY_DIRECTOR
BioNTech SE

Study Locations (Sites)

Alaska Oncology and Hematology, LLC
Anchorage, Alaska, 99508
United States
Valkyrie Clinical Trials
Los Angeles, California, 90067
United States
Clermont Oncology Center
Clermont, Florida, 34711
United States
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952
United States
Tallahassee Memorial Physician Partners - Cancer & Hematology Specialists
Tallahassee, Florida, 32308
United States
Carle Foundation Hospital d/b/a Carle Cancer Center
Urbana, Illinois, 61801
United States
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, 46804
United States
University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center)
Lexington, Kentucky, 40536
United States
Allina Health
Minneapolis, Minnesota, 55407
United States
Hattiesburg Clinic - Hattiesburg
Hattiesburg, Mississippi, 39401
United States
SSM Health Cancer Care - St. Clare
Fenton, Missouri, 63026
United States
Nebraska Hematology-Oncology (NHO) - Lincoln
Lincoln, Nebraska, 68506
United States
Clinical Research Alliance Inc
Westbury, New York, 11590
United States
Haywood Infusion Center
Clyde, North Carolina, 28721-8046
United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374
United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
Millenium Research & Clinical Development
Houston, Texas, 77090
United States
SSM Health Cancer Care
Madison, Wisconsin, 53715
United States

Collaborators and Investigators

Sponsor: BioNTech SE

  • BioNTech Responsible Person, STUDY_DIRECTOR, BioNTech SE

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-05
Study Completion Date2026-08

Study Record Updates

Study Start Date2024-08-05
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • Programmed Death-1 (PD-1)
  • Programmed Death Ligand-1 (PD-L1)
  • Programmed Death-1 monoclonal antibodies
  • Combination chemotherapy
  • Anti vascular endothelial growth factor (VEGF)
  • Previously treated small-cell lung cancer
  • Untreated extensive-stage small-cell lung cancer
  • Dose optimization
  • Time to progression

Additional Relevant MeSH Terms

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