NCT06841055 · BioNTech SE
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy Following Chemoimmunotherapy
What this study is about
This is a Phase II, multisite, where both patients and doctors know the treatment given, single treatment group$1 study with two parts in participants with advanced/metastatic NSCLC which progressed after a first-line chemoimmunotherapy. Part 1 is safety run-in with BNT327 (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants to be treated in Part 1A and 1B sequentially.
View original scientific description
This is a Phase II, multisite, open-label, single arm study with two parts in participants with advanced/metastatic NSCLC which progressed after a first-line chemoimmunotherapy. Part 1 is safety run-in with BNT327 (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants to be treated in Part 1A and 1B sequentially. Part 2 is a dose expansion at the deemed safe dose of BNT327 plus docetaxel.
Interventions
DRUG
Pumitamig
Intravenous infusion
DRUG
Docetaxel
Intravenous infusion
Primary outcome measures
Part 1 - Occurrence of dose limiting toxicities (DLTs)
Time frame: Up to 21 days after first dose of investigational medicinal product (IMP)
During the DLT evaluation period by dose level
Part 1 and Part 2 - Occurrence of pumitamig treatment emergent adverse events, treatment-related adverse events, treatment emergent serious adverse events, treatment-related serious adverse events, and adverse events of special interest
Time frame: From initiation of the first dose of IMP to the 90-day Follow-Up visit
Graded according to the (United States) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
Part 1 and Part 2 - Occurrence of dose interruption, dose reduction, and/or participant discontinuation due to adverse events
Time frame: From initiation of the first dose of IMP until the 90-day Safety Follow-up visit
Part 1 and Part 2 - Objective response rate
Time frame: Up to approximately 2 years
Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) based on investigator's review) is observed as best overall response.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Have histologically or cytologically confirmed diagnosis of Stage IV NSCLC that has documented radiographic progression on one or after one prior line of systemic treatment (programmed death-1 \[PD-1\]/ programmed death ligand-1 \[PD-L1\] inhibitor and platinum-based chemotherapy concomitantly) in advanced/metastatic setting per the American Joint Committee on Cancer staging system, 8th edition.
- Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this trial.
- Only one prior line of immunotherapy containing regimen is allowed in advanced/metastatic setting. If participant had received adjuvant immunotherapy the disease-free interval (after the last dose of adjuvant immunotherapy) should be at least 6 months.
- Historical PD-L1 results must be available.
- Patients with actionable genetic alterations are allowed to be enrolled if patients received locally approved and available targeted agent
Where
- Birmingham, Alabama
- Tampa, Florida
- Elizabethtown, Kentucky
- New York, New York
- Houston, Texas
Collaborators
BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2026 · Source of record for eligibility and locations