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Looking for participantsPhase2

Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment

Sponsor: BioNTech SE

NCT ID: NCT06841055

View on ClinicalTrials.gov ↗

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.

Non-small Cell Lung Cancer

How this trial compares with your answers

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What we know so far

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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

PD-L1

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
Key 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, 9th edition. * Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this study. * Only one prior line of immunotherapy containing regimen is allowed in an 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. * Participants with actionable genetic alterations may be enrolled if they received locally approved and available targeted agent in combination with immunotherapy in first-line advanced/metastatic setting. * Enrollment of participants with primary resistance (best response being radiological progression to prior immunochemotherapy) will be kept below 30% in the overall study population. * Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been documented after irradiation. Historical images within 28 days of the screening visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator. * Participants must provide tumor tissue samples obtained ≤18 months prior to enrollment. For the additional cohort in Part 2, both baseline (freshly obtained) and on-treatment tumor biopsy samples are required. * Eastern cooperative oncology group performance status of 0 or 1. * Adequate organ function as defined in the protocol. Key Exclusion Criteria: * Have a known or suspected hypersensitivity to the study treatments, their metabolites or formulation of excipients including polysorbate 80 (see Docetaxel label). * Participants who received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or anti-PD-(L)-1/aVEGF bispecific antibody or docetaxel as monotherapy or in combination with other agents. * Have received more than one prior lines of therapies in advanced/metastatic setting. * Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment (except for docetaxel premedication). Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed. * Participants who have received prior radiotherapy may be enrolled if they have no acute toxicity related to this therapy. * Have uncontrolled hypertension or poorly controlled diabetic conditions within 7 days prior to the first dose of study treatment. * Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation. * Participants with significant risk of hemorrhage as defined in the protocol. * Have superior vena cava syndrome or symptoms of spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Where Is This Study? (4 UK sites)

Velindre NHS Trust, Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Townsend

Velindre.R&Doffice@wales.nhs.uk02920 196165

St James's University Hospital - Leeds Teaching Hospitals NHS Trust

Leeds LS9 7TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

Sarah Cannon Research Institute

London W1G 6AD, United Kingdom

Recruiting

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

How to Get in Touch

BioNTech clinical trials patient information

Sponsor contact

CONTACT

+49 6131 9084 patients@biontech.de
Data sourced from ClinicalTrials.gov · Last verified: 2026-04