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New drug duo aims to shrink tough lung cancers

NCT ID NCT06892548

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 27, 2026 · Updated 6 times

Summary

This study is testing two experimental drugs, BNT324 and BNT327, together in people with advanced lung cancer that has spread or come back. BNT324 targets and delivers a toxin to cancer cells, while BNT327 helps the immune system attack tumors and cuts off their blood supply. The trial will enroll about 594 participants to find the best dose and see if the combination can shrink tumors safely.

What this could mean

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

Active substance
BNT324 (a drug that targets cancer cells) and BNT327 (a drug that boosts the immune system and blocks blood vessel growth)
What this could lead to
If this works, it could offer a new treatment option for people with advanced lung cancer that has stopped responding to other therapies.
What could go wrong
This is an early-phase trial, so the combination may not work or could cause serious side effects. It is not yet known if it will be better than existing treatments.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 594 people

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

Started

May 2025

Expected to finish

May 2032

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.

Inclusion Criteria: * Aged ≥18 years at the time of giving informed consent. * Histological or cytological confirmed unresectable advanced/metastatic lung cancer. Histological classification may be based on tumor samples prior to metastatic disease. Participants with mixed histology must be classified based on the main component. Participants with NSCLC are eligible with any or no PD-L1 expression. Participants with AGA-positive disease must have received targeted therapy prior to enrollment in this study. * Part 1: Participants with NSCLC and SCLC * Part 2 Cohort 1: Participants with NSCLC (subpopulation 1) AGA negative, 1L * Part 2 Cohort 2: Participants with SCLC, 2L+ * Part 2 Cohort 3: Participants with NSCLC (subpopulation 1) AGA negative, 2L+ * Part 2 Cohort 4: Participants with NSCLC (subpopulation 2) AGA negative, 1L * Part 2 Cohort 5: Participants with NSCLC (subpopulation 2) AGA negative, 2L+ * Part 2 Cohort 6: Participants with NSCLC AGA positive * Part 2 Cohort 7: Participants with SCLC, 1L * Have measurable disease defined by RECIST version 1.1. * Have an Eastern Cooperative Oncology Group performance status of 0 or 1. * Have a life expectancy of ≥12 weeks. Exclusion Criteria: * Prior treatment with B7-H3 targeted therapy. * Prior treatment with ADC with topoisomerase inhibitor (e.g., datopotamab deruxtecan, trastuzumab deruxtecan). Note: This exclusion applies to participants in the first-line/treatment-naïve cohorts in the advanced/metastatic setting. Prior treatment with ADC with topoisomerase inhibitor payload is only allowed for participants in the second-line plus cohorts in the advanced/metastatic setting. * Is a candidate to locoregional treatment (including surgical resection, stereotactic radiotherapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as "radical" intent), per investigator's assessment. * Has a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or recurrent/persistent Grade 3 to 4 neutropenia. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply to all or some participants depending on the cohort.

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Conditions

The condition(s) this trial relates to.

lung cancer lung carcinoma non-small cell lung carcinoma small cell lung carcinoma

As listed by the trial registrant

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

Advanced 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

    91 sites in 10 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

  • Adana City Hospital

    RECRUITING

    Adana, 01230, Turkey (Türkiye)

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    RECRUITING

    Guandong, 510095, China

  • Anhui Provincial Cancer Hospital

    RECRUITING

    Hefei, Anhui, 230088, China

  • Ankara City Hospital

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Assistance Publique-Hôpitaux de Marseille

    RECRUITING

    Marseille, 13005, France

  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

    RECRUITING

    Verona, 37134, Italy

  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

    RECRUITING

    Naples, 80131, Italy

  • Barwon Health

    RECRUITING

    Geelong, Victoria, 3220, Australia

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Beijing GoBroad Hospital

    RECRUITING

    Beijing, Beijing Municipality, 102200, China

  • Bendigo Hospital

    RECRUITING

    Bendigo, Victoria, 3550, Australia

  • Bristol Haematology and Oncology Centre

    RECRUITING

    Bristol, BS2 8ED, United Kingdom

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Intercommunal de Créteil

    RECRUITING

    Créteil, 94000, France

  • Centrum Medyczne Pratia Poznań

    RECRUITING

    Poznan, 60-192, Poland

  • Chris O'Brien Lifehouse

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinica Universidad de Navarra

    RECRUITING

    Barcelona, 08036, Spain

  • Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

    RECRUITING

    Ankara, 06105, Turkey (Türkiye)

  • First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • Flinders Medical Centre

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, Guangxi Zhuang, 530021, China

  • Hacettepe University Medical Faculty

    RECRUITING

    Ankara, 06100, Turkey (Türkiye)

  • Henan Provincial Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Hopital Larrey

    RECRUITING

    Toulouse, 31059, France

  • Hospital Quironsalud Malaga

    RECRUITING

    Málaga, 29004, Spain

  • Hospital Universitari Dexeus

    RECRUITING

    Barcelona, 08028, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08740, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Nuestra Señora de Valme

    RECRUITING

    Seville, 41014, Spain

  • Hospital Universitario Reina Sofia

    RECRUITING

    Córdoba, 14004, Spain

  • Hospital Universitario de Torrejón

    RECRUITING

    Torrejón de Ardoz, 28850, Spain

  • Hunan Province People's Hospital

    RECRUITING

    Changsha, Hunan, 410005, China

  • Hôpital Foch

    RECRUITING

    Suresnes, 92151, France

  • IRCCS Istituto di Candiolo

    RECRUITING

    Candiolo, 10060, Italy

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Icahn School of Medicine at Mount Sinai PRIME

    RECRUITING

    New York, New York, 10029, United States

  • Istituto Nazionale Tumori Regina Elena IRCCS

    RECRUITING

    Roma, 00144, Italy

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, Jiangxi, 330209, China

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, Jilin, 130000, China

  • Jinan Central Hospital

    RECRUITING

    Jinan, Shandong, 250013, China

  • Jingzhou First People's Hospital

    RECRUITING

    Jingzhou, Hubei, 434000, China

  • John Theurer Cancer Center at Hackensack UMC

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • Koc University Hospital

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • Linyi Cancer Hospital

    RECRUITING

    Shandong, Linyi, 276001, China

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Mayo Clinic Arizona

    RECRUITING

    Phoenix, Arizona, 13400, United States

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic-Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center (MSKCC)

    RECRUITING

    New York, New York, 10021, United States

  • Nanjing Chest Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Cancer Center

    RECRUITING

    Taipei, 106, Taiwan

  • Pratia Onkologia Katowice

    RECRUITING

    Katowice, 40-519, Poland

  • Precision NextGen Oncology and Research Center

    RECRUITING

    Beverly Hills, California, 90212, United States

  • Regional Cancer Care Associates

    RECRUITING

    Belleville, New Jersey, 07109, United States

  • Royal Preston Hospital

    RECRUITING

    Preston, PR29HT, United Kingdom

  • Sakarya Training and Research Hospital

    RECRUITING

    Sakarya, 54187, Turkey (Türkiye)

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shanghai GoBroad Cancer Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200125, China

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • St George's Hospitals NHS Foundation Trust

    RECRUITING

    London, SW170QT, United Kingdom

  • St John of God Subiaco Hospital

    RECRUITING

    Subiaco, Western Australia, 6008, Australia

  • St. James's University Hospital

    RECRUITING

    Leeds, LS97TF, United Kingdom

  • Sunshine Hospital

    RECRUITING

    Saint Albans, Victoria, 3021, Australia

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 11217, Taiwan

  • Texas Oncology - DFW

    RECRUITING

    Dallas, Texas, 75246, United States

  • Texas Oncology - Northeast

    RECRUITING

    Tyler, Texas, 75702, United States

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M204BX, United Kingdom

  • The Clatterbridge Cancer Center

    RECRUITING

    Liverpool, L7 8YA, United Kingdom

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330209, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Fujian, 361003, China

  • The First Affiliated Hospital of Xian Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital of Xinxiang Medical University

    RECRUITING

    Weihui, Henan, 453100, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • UCLA - David Geffen School of Medicine

    RECRUITING

    Santa Monica, California, 90404, United States

  • University College London Hospital

    RECRUITING

    London, W1T 7HA, United Kingdom

  • University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Iowa Hospitals & Clinics PARENT

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80-214, Poland

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, 611100, China

  • Xiangyang Central Hospital

    RECRUITING

    Xiangyang, Hubei, 441021, China

  • Xuzhou Central Hospital

    RECRUITING

    Xuzhou, 221018, China

  • Yeditepe University Medical School Hospital

    RECRUITING

    Istanbul, 31755, Turkey (Türkiye)

  • Yichang Central People's Hospital

    RECRUITING

    Yichang, Hubei, 443000, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310022, China

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