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New drug combo aims to fight lung cancer after first treatment fails

NCT ID NCT06841055

Disease control Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called pumitamig (BNT327) combined with standard chemotherapy (docetaxel) in 60 people with advanced non-small cell lung cancer that got worse after initial treatment. The goal is to see if the combination is safe and shrinks tumors. It is an early-phase, open-label trial currently recruiting participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pumitamig (also called BNT327, PM8002, or BMS-986545) combined with docetaxel chemotherapy
What this could lead to
If successful, this could offer a new treatment option for people with advanced lung cancer whose first therapy stopped working.
What could go wrong
This is an early Phase 2 trial with only 60 participants, so results may not apply to everyone. The combination may cause side effects like infusion reactions or immune-related issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ankara Bilkent City Hospital

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Baptist Health Hardin

    RECRUITING

    Elizabethtown, Kentucky, 42701, United States

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

    RECRUITING

    Adana, 01250, Turkey (Türkiye)

  • Cancer Research SA (CRSA)

    RECRUITING

    Adelaide, South Austraila, 5000, Australia

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, 28644, South Korea

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, 21565, South Korea

  • Gyeongsang National University Hospital (GNUH)

    RECRUITING

    Jinju, Gyeongsangnam-do, 52727, South Korea

  • Hobart Hospital-Royal Hobart Hospital

    RECRUITING

    Hobart, Tasmania, 7000, Australia

  • Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Institut dInvestigacio Biomedica de Bellvitge (IDIBELL)

    RECRUITING

    Barcelona, 08908, Spain

  • Koc Universitesi Hastanesi (Koc University Hospital)

    RECRUITING

    Zeytinburnu, 34010, Turkey (Türkiye)

  • Liverpool Cancer Therapy Centre

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Memorial Ankara Hospital

    RECRUITING

    Ankara, 06520, Turkey (Türkiye)

  • Memorial Antalya Hospital

    RECRUITING

    Antalya, 07090, Turkey (Türkiye)

  • Metro South Health - Princess Alexandra Hospital (PAH)

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NYU Langone - NYU Grossman School of Medicine

    RECRUITING

    New York, New York, 10016, United States

  • One Clinical Research - Hollywood Private Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

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

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Texas Oncology, P.A.

    COMPLETED

    Houston, Texas, 77090, United States

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The University of Alabama at Birmingham Hospital

    RECRUITING

    Birmingham, Alabama, 35249, United States

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

    RECRUITING

    Valencia, 46026, Spain

  • Velindre NHS Trust, Velindre Cancer Centre

    RECRUITING

    Cardiff, CF14 2TL, United Kingdom

  • Yeditepe University Hospital

    RECRUITING

    Istanbul, 34752, Turkey (Türkiye)

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