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Non-small Cell Lung CancerPhase 2NCT06841055

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

A Phase 2 study testing Pumitamig and Docetaxel in people with Non-small Cell Lung Cancer, run by BioNTech SE at 30 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Pumitamig and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
30 sitesin 6 countries
Study dates
3 Mar 2025to Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

30 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

BioNTech clinical trials patient information contact

+49 6131 9084 ext. 0

patients@biontech.de

30 sites in 6 countries

Turkey (Türkiye)6 sites, 6 recruiting

  • Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus

    Adana, 01250

    Recruiting

  • Memorial Ankara Hospital

    Ankara, 06520

    Recruiting

  • Ankara Bilkent City Hospital

    Ankara, 06800

    Recruiting

  • Memorial Antalya Hospital

    Antalya, 07090

    Recruiting

  • Yeditepe University Hospital

    Istanbul, 34752

    Recruiting

  • Koc Universitesi Hastanesi (Koc University Hospital)

    Zeytinburnu, 34010

    Recruiting

Other trials in Turkey (Türkiye)

United States5 sites, 4 recruiting

  • The University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35249

    Recruiting

  • Baptist Health Hardin

    Elizabethtown, Kentucky, 42701

    Recruiting

  • Texas Oncology, P.A.

    Houston, Texas, 77090

    Completed

  • NYU Langone - NYU Grossman School of Medicine

    New York, New York, 10016

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

Other trials in United States

Australia5 sites, 5 recruiting

  • Cancer Research SA (CRSA)

    Adelaide, South Austraila, 5000

    Recruiting

  • Hobart Hospital-Royal Hobart Hospital

    Hobart, Tasmania, 7000

    Recruiting

  • Liverpool Cancer Therapy Centre

    Liverpool, New South Wales, 2170

    Recruiting

  • One Clinical Research - Hollywood Private Hospital

    Nedlands, Western Australia, 6009

    Recruiting

  • Metro South Health - Princess Alexandra Hospital (PAH)

    Woolloongabba, Queensland, 4102

    Recruiting

Other trials in Australia

South Korea5 sites, 5 recruiting

  • Chungbuk National University Hospital

    Cheongju-si, 28644

    Recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565

    Recruiting

  • Gyeongsang National University Hospital (GNUH)

    Jinju, Gyeongsangnam-do, 52727

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

Other trials in South Korea

Spain5 sites, 5 recruiting

  • Institut dInvestigacio Biomedica de Bellvitge (IDIBELL)

    Barcelona, 08908

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Recruiting

  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

    Valencia, 46026

    Recruiting

Other trials in Spain

United Kingdom4 sites, 4 recruiting

  • Velindre NHS Trust, Velindre Cancer Centre

    Cardiff, CF14 2TL

    Recruiting

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

    Leeds, LS9 7TF

    Recruiting

  • Sarah Cannon Research Institute

    London, W1G 6AD

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Phase II, Multisite, Open-label Trial of Pumitamig (BNT327) in Combination With Standard-of-care Chemotherapy in First-line and Second-line Non-small Cell Lung Cancer (NSCLC)

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.

Read the detailed description

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.

Being tested
Pumitamig, Docetaxel
Keywords
Second-line treatment, Immunotherapy, Combination with other investigational agents, Bispecific antibody, Vascular endothelial growth factor (VEGF) A, Programmed death-ligand 1 (PD-L1), Combination with chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PumitamigDrug

    Also called BNT327, PM8002, BMS-986545

    Intravenous infusion

  • DocetaxelDrug

    Intravenous infusion

Study groups in NCT06841055
Study groupRoleWhat they receive
Part 1A - Pumitamig Dose 1 + docetaxelExperimentalNot described
Receives: Drug: Pumitamig; Drug: Docetaxel
Part 1B - Pumitamig Dose 2 + docetaxelExperimentalNot described
Receives: Drug: Pumitamig; Drug: Docetaxel
Part 2: Selected doses of pumitamig + docetaxelExperimentalPumitamig and docetaxel will be administered at the dose level recommended by an internal review committee based on the observed safety profile from Part 1.
Receives: Drug: Pumitamig; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 - Occurrence of dose limiting toxicities (DLTs)

    During the DLT evaluation period by dose level

    Measured: Up to 21 days after first dose of investigational medicinal product (IMP)

  2. 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

    Graded according to the (United States) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)

    Measured: From initiation of the first dose of IMP to the 90-day Follow-Up visit

  3. Part 1 and Part 2 - Occurrence of dose interruption, dose reduction, and/or participant discontinuation due to adverse events

    Measured: From initiation of the first dose of IMP until the 90-day Safety Follow-up visit

  4. Part 1 and Part 2 - Objective response rate

    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.

    Measured: Up to approximately 2 years

Secondary outcomes (8)

  1. Part 1 and Part 2 - Duration of Response

    Defined as the time from first objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) to first occurrence of objective tumor progression (progressive disease, per RECIST v1.1 based on the investigator's assessment) or death from any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  2. Part 1 and Part 2- Progression-free Survival

    Based on the investigator's assessment defined as the time from first dose of IMP to the first objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  3. Part 1 and Part 2 - Depth of Response

    Defined as the maximum percent reduction from baseline in tumor size measured by sum of target lesion diameter (including nodal [short axis] and non-nodal [longest axis] lesions).

    Measured: Up to approximately 2 years

  4. Part 1 and Part 2 - Disease Control Rate

    Defined as the proportion of participants with confirmed CR, confirmed PR, or stable disease (per RECIST v1.1 based on the investigator's assessment) as best overall response.

    Measured: Up to approximately 2 years

  5. Part 1 and Part 2 - Time to Response

    Defined as the time from first dose of IMP to first objective response (CR or PR per RECIST v1.1 based on the investigator's assessment).

    Measured: Up to approximately 2 years

  6. Part 1 and Part 2 - Overall Survival

    Defined as the time from first dose of IMP to death from any cause

    Measured: Up to approximately 2 years

  7. Part 1 and Part 2 - Pharmacokinetic assessment: Maximum concentration (Cmax) derived from serum concentration of pumitamig

    Measured: From pre-dose to the end of study treatment (up to approximately 2 years)

  8. Part 1 and Part 2 - Number of participants developing detectable anti-pumitamig antibodies in serum

    Measured: From pre-dose to the end of study treatment (up to approximately 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start3 Mar 2025
  3. Primary completionOct 2028 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06841055
Sponsor's protocol ID
BNT327-07
Other IDs
2024-518279-80-00
Status last verified
Apr 2026
First submitted
20 Feb 2025
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pumitamig and Docetaxel in people with Non-small Cell Lung Cancer, run by BioNTech SE at 30 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Turkey (Türkiye), United States, Australia, South Korea, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BioNTech clinical trials patient information (+49 6131 9084 ext. 0, patients@biontech.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 - Occurrence of dose limiting toxicities (DLTs) (time frame: Up to 21 days after first dose of investigational medicinal product (IMP)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06841055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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