At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pumitamig (drug), Docetaxel (drug)
- How long the study runs
- Study runs about 43 months (dates as stated)
- About the drug or intervention
- Pumitamig — drug: Intravenous infusion · Docetaxel — drug: Intravenous infusion
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is looking at an experimental drug called pumitamig (BNT327) given with chemotherapy for people with stage 4 non-small cell lung cancer (NSCLC) whose disease got worse during or after one previous course of treatment. The study is checking whether the treatment is safe and whether it shows early signs of working. It is run by BioNTech SE.
Who can take part
- Have a confirmed diagnosis of stage 4 non-small cell lung cancer that got worse on or after one previous course of treatment (immunotherapy plus platinum chemotherapy) in the advanced stage of the disease.
- Must have had at least two cycles of immunotherapy as first treatment, and only one previous immunotherapy course is allowed. If immunotherapy was given after surgery, there must have been at least 6 months without disease afterwards.
- Existing results for PD-L1 (a protein on cancer cells) must be available.
- People with certain genetic changes may join if they had an approved targeted drug with immunotherapy as their first treatment.
- No more than 30 in 100 people in the study will have had cancer that did not respond at all to previous immunotherapy plus chemotherapy.
- Have at least one tumour that can be measured on a scan. Tumours in an area treated with radiotherapy count if they have grown since.
- Provide a tumour tissue sample taken within the last 18 months. For one extra group in part 2, fresh tumour samples before and during treatment are needed.
- Be able to carry out normal daily activities with little or no restriction (performance status 0 or 1).
- Have organs (such as liver and kidneys) working well enough, as defined in the study plan.
Who may not be able to
- Known or suspected allergy to the study treatments or their ingredients, including polysorbate 80.
- Previous treatment with drugs that block VEGF (a blood-vessel growth signal), drugs that combine anti-PD-(L)-1 and anti-VEGF action, or the chemotherapy drug docetaxel.
- More than one previous course of treatment in the advanced stage of the disease.
- Taking steroid tablets above a certain dose (over 10 mg a day of prednisone or similar) within 7 days before starting study treatment, except some exceptions listed in the criteria.
- Uncontrolled high blood pressure or poorly controlled diabetes within 7 days before the first dose.
- A serious or non-healing wound, unhealed bone fracture, or history of certain problems such as fistulas, holes in the bowel, abscesses, or bleeding in the stomach or gullet within the past 6 months.
- Significant risk of serious bleeding, as defined in the study plan.
- Superior vena cava syndrome (a blockage of a major vein) or symptoms of spinal cord compression.
What taking part involves
- • Taking the experimental drug pumitamig (BNT327) together with chemotherapy.
- • Providing tumour tissue samples; for one group in part 2, extra tumour samples (biopsies) before and during treatment.
- • Scans to measure tumours, including a scan at the start (screening).
Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 60
- Started
- 2025-03-03
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for non-small cell lung cancer
- • Phase2 - 60 participants
- • This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standard of care
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-small cell lung cancer
Where?
- • Cardiff - Velindre NHS Trust, Velindre Cancer Centre
- • Leeds - St James's University Hospital - Leeds Teaching Hospitals NHS Trust
- • London - Sarah Cannon Research Institute
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standard of care. Part 1 is a safety run-in with pumitamig (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants in total to be treated in Part 1A and 1B sequentially. Part 2 is a dose expansion at the deemed safe dose of pumitamig plus docetaxel and will include up to 54 participants.
More detail
If the dose level (either from Part 1A or 1B) seems tolerable, an internal review committee will decide if the study can proceed to Part 2 and enroll additional participants. In Part 2, participants who consent will be included in a separate cohort in which they will receive the same treatment as the other participants in Part 2, but in addition to a fresh baseline tumor biopsy, they will be required to provide an on-treatment tumor biopsy sample for additional analyses. Study participants will receive pumitamig in combination with docetaxel until disease progression, the occurrence of intolerable toxicity, study participant withdrawal, death, study termination or 2-year limit (whichever comes first). After completion of study treatment, except for participants who withdraw informed consent, a long-term follow-up will be conducted for all participants to record disease progression, subsequent new anticancer treatments, and survival status.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ of systemic treatment (programmed death-1 \[PD-1\]/ programmed death lig
- ✓ received minimum two cycles of immunotherapy in first-line treatment to be eligible to this study
- ✓ of immunotherapy containing regimen is allowed in an advanced/metastatic setting
What the study is looking for
- ✓Participants must have received minimum two cycles of treatment that helps your immune system fight cancer in first-line treatment to be eligible to this...
- ✓Historical PD-L1 results must be available.
- ✓Enrollment of participants with primary resistance (best response being radiological progression to prior...
- ✓activity scale performance status of 0 or 1.
- ✓healthy organ as defined in the protocol.
Who cannot take part
- ✗Have a known or suspected hypersensitivity to the study treatments, their metabolites or formulation of excipients...
- ✗Have received more than one prior lines of therapies in advanced/that has spread setting.
- ✗Participants who have received prior radiotherapy may be enrolled if they have no acute toxicity related to this...
- ✗Have uncontrolled hypertension or poorly controlled diabetic conditions within 7 days prior to the first dose of...
- ✗Participants with significant risk of hemorrhage as defined in the protocol.
See the full criteria
Where Is This Study? (4 UK sites)
Velindre NHS Trust, Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds LS9 7TF, United Kingdom
Sarah Cannon Research Institute
London W1G 6AD, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
BioNTech clinical trials patient information
Sponsor contactCONTACT
