Study on the Safety and Effectiveness of BNT327 with Chemotherapy for Lung Cancer
Sponsor: BioNTech SE
ClinicalTrials ID:NCT06712316
This clinical trial is testing a new drug, BNT327, in combination with chemotherapy to see if it is safe and effective for treating non-small cell lung cancer (NSCLC). The study is divided into two parts and will include participants with different types of NSCLC.
Patient Parameters
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Program Overview
This study is designed to test a new treatment for non-small cell lung cancer (NSCLC) using a drug called BNT327 along with chemotherapy. It is a Phase 2/3 study, meaning it will first test the safety and effectiveness of the treatment (Phase 2) and then confirm these results in a larger group (Phase 3). The study is divided into two substudies based on the type of NSCLC, as different types may require different chemotherapy treatments. Participants will be randomly assigned to receive one of two doses of BNT327 in combination with chemotherapy. The results from Phase 2 will help decide which dose to use in Phase 3. An independent committee will monitor the study to ensure safety and effectiveness.
Description
The study is divided into two main parts: Phase 2 and Phase 3. In Phase 2, participants will be randomly assigned to receive one of two doses of BNT327 along with chemotherapy. The goal is to determine which dose is safer and more effective. After analyzing the results from Phase 2, a committee will decide which dose to use in Phase 3, where more participants will be treated with the selected dose. An independent committee will review the data to ensure the treatment is safe and effective. The study may stop recruiting participants in Phase 2 if data from other related studies suggest it is not beneficial to continue.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiotherapy.
- Do not have specific genetic mutations (EGFR or ALK) that are known to affect treatment.
- Have at least one tumor that can be measured by scans.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ function as determined by medical tests.
Exclusion Criteria
- Have a type of lung cancer that includes small-cell lung cancer.
- Have received certain cancer treatments or drugs recently, including specific antibodies or chemotherapy.
- Have taken high doses of steroids recently, except for certain short-term uses.
- Have uncontrolled high blood pressure or poorly managed diabetes.
- Have serious wounds, ulcers, or bone fractures that are not healing.
- Have a history of certain medical conditions like fistulas or abscesses unless they have healed.
- Have major blood clotting disorders or a high risk of bleeding.
- Have certain serious conditions like superior vena cava syndrome or spinal cord compression.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alaska Oncology and Hematology, LLC | 99508 | Anchorage | Alaska |
| Clermont Oncology Center | 34711 | Clermont | Florida |
| Millennium Research and Clinical Development, LLC | 77090 | Houston | Texas |
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