Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (NCT06449209)

🧪 Interventions in This Study

• BNT327 Dose Level 1 (DL1) (DRUG)
• BNT327 Dose Level 2 (DL2) (DRUG)
• Etoposide (DRUG)
• Carboplatin (DRUG)
• Paclitaxel (DRUG)
• Topotecan (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. (applicable to all participants unless otherwise specified):
2. Cohort 1 only: Have histologically or cytologically confirmed ES-SCLC (using the American Joint Committee on Cancer \[AJCC\]) tumor node metastasis \[TNM\] staging system combined with Veterans Administration Lung Study Group two-stage classification scheme). For AJCC TNM staging system: AJCC 8th edition stage IV (T any, N any, M1a/b/c), or T3\~4 for multiple lung nodules or tumor/nodule volume that cannot be encompassed in a tolerable radiotherapy plan.
3. Cohort 1 only: Participants who have not received systemic therapy for ES-SCLC for various reasons including potential intolerance of the standard-of-care per the patient's treating physician's judgment. However, participants with prior chemoradiotherapy for Limited-Stage Small-Cell Lung Cancer (LS-SCLC) must have been treated with curative intent and had a treatment-free interval of at least 6 months since the last systemic anticancer treatment including chemotherapy, radiotherapy, or chemoradiotherapy before the diagnosis of ES-SCLC to be eligible.
4. Cohort 2 and Cohort 3 only: Participants with SCLC who have disease progression/relapse after first-line platinum-based chemotherapy with or without immunotherapy, or after first-line platinum-based chemotherapy and one second-line of chemotherapy (not the same chemotherapy agent in the specific arm to be enrolled to) with time to progression ≥3 months during second-line treatment.
5. Have given informed consent by signing and dating an informed consent form before initiation of any study-specific procedures.
6. Male or female, aged ≥18 years at the time of giving informed consent.
7. Are willing and able to comply with scheduled visits, treatment schedule, the planned study assessments, laboratory tests, lifestyle restrictions, and other requirements of the study. This includes that they are able to understand and follow study-related instructions.
8. Have at least one measurable lesion as the targeted lesion based on RECIST 1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
9. Eastern Cooperative Oncology Group performance status of 0 or 1.
10. Have a minimum life expectancy of \>3 months.
11. Have adequate organ function, as defined below:
12. Hematology:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (64 Sites)

Showing the first 25 of 64 sites.

• Alaska Oncology and Hematology, LLC — Anchorage, Alaska
• Valkyrie Clinical Trials — Los Angeles, California
• Clermont Oncology Center — Clermont, Florida
• Hematology Oncology Associates of Treasure Coast — Port Saint Lucie, Florida
• Tallahassee Memorial Physician Partners - Cancer & Hematology Specialists — Tallahassee, Florida
• Carle Foundation Hospital d/b/a Carle Cancer Center — Urbana, Illinois
• Fort Wayne Medical Oncology and Hematology, Inc — Fort Wayne, Indiana
• University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center) — Lexington, Kentucky
• Allina Health — Minneapolis, Minnesota
• SSM Health Cancer Care - St. Clare — Fenton, Missouri
• Nebraska Hematology-Oncology (NHO) - Lincoln — Lincoln, Nebraska
• Clinical Research Alliance Inc — Westbury, New York
• Haywood Infusion Center — Clyde, North Carolina
• FirstHealth Outpatient Cancer Center — Pinehurst, North Carolina
• The Christ Hospital Cancer Center — Cincinnati, Ohio
• University of Tennessee Medical Center — Knoxville, Tennessee
• Millenium Research & Clinical Development — Houston, Texas
• SSM Health Cancer Care — Madison, Wisconsin
• Lyell McEwin Hospital — Adelaide,
• St. Vincent's Hospital — Fitzroy,
• Peninsula Oncology Centre — Frankston,
• Royal North Shore Hospital — St Leonards,
• Westmead Hospital — Westmead,
• Chungbuk National University Hospital — Cheongju-si,
• Yeungnam University Medical Center — Daegu,

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Extensive-stage Small-cell Lung Cancer

• A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC — Los Angeles, California
• Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer — Tucson, Arizona
• Study of Bevacizumab in Combination With Chemoimmunotherapy and Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver Metastases — Los Angeles, California
• Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC) — Springdale, Arkansas
• Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab — Mobile, Alabama
• A Study of Valemetostat in Combination With Atezolizumab in People With Lung Cancer — Basking Ridge, New Jersey

Explore by condition: All Extensive-stage Small-cell Lung Cancer clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.