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Lung cancer combo trial halted early

NCT ID NCT05469178

Disease control Sponsor: BerGenBio ASA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 early-stage trial tested a new drug called bemcentinib added to standard chemotherapy and immunotherapy for people with advanced non-squamous lung cancer. The study aimed to check safety and find the right dose, but it was terminated early. Only 26 people took part, so we cannot draw firm conclusions about how well it works.

What this could mean

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

Active substance
bemcentinib (a drug taken orally) combined with pembrolizumab, carboplatin, and pemetrexed (standard chemotherapy and immunotherapy)
What this could lead to
If it had succeeded, this could have pointed toward a new treatment option for people with a specific genetic mutation (STK11) in advanced lung cancer.
What could go wrong
The trial was terminated early, so results are limited. It was a small, early-phase study (Phase 1b/2a) focused on safety, not proof of effectiveness. The combination may also cause side effects from multiple drugs.

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

26 people

The number who actually took part.

Started

Mar 2023

Finished

Apr 2025

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.

Main Inclusion Criteria: * Histologically-confirmed or cytologically confirmed diagnosis of advanced (Stage IIIb/IIIc) or metastatic (Stage IV) (AJCC Edition 8) non-squamous NSCLC not amenable to curative therapy, irrespective of PD-L1 status and without actionable mutations (Phase 1b) targetable with first-line treatment. * Histologically-confirmed or cytologically confirmed diagnosis of stage of advanced (Stage IIIb/IIIC) or metastatic (Stage IV) (AJCC, Edition 8) non-squamous NSCLC with STK11 mutation, not amenable to curative therapy, irrespective of PD-L1 status and without actionable mutations (phase 2a) targetable with first-line treatment. * Have not received prior systemic treatment for their advanced/metastatic NSCLC * Have measurable disease per RECIST 1.1 as assessed by the investigator Main Exclusion Criteria: * Has received any prior chemotherapy or biological therapy for locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) adenocarcinoma of the lung * Received radiation therapy within 2 weeks prior to starting study treatment or has not recovered (i.e. \<=Grade 1 at baseline) from AEs due to a previous radiation therapy * Major surgery within 28 days prior to start of study treatment and failure to have recovered adequately from the complications of the surgery/intervention prior to the first dose of study treatment

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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.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

  • Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi

    Bologna, 40138, Italy

  • Centre Antoine Lacassagne

    Nice, 6189, France

  • Duke University Medical Center - Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Fejer County St. Gyorgy Hospital

    Székesfehérvár, 8000, Hungary

  • Fundacion Instituto Valenciano de Oncologia (FIVO)

    Valencia, 46009, Spain

  • General Hospital of Athens Alexandra, Department of the Clinical Therapeutics, Medical Oncology Unit

    Athens, 11528, Greece

  • Henry Dunant Hospital Center, 4th Oncology Department

    Athens, 115 26, Greece

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 8916, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 8035, Spain

  • Hôpital Europeen Georges Pompidou (HEGP), Service de cancérologie

    Paris, 75015, France

  • Hôpital prive du Confluent SAS, Departement d'oncologie

    Nantes, 44277, France

  • IFO Regina Elena

    Rome, 144, Italy

  • IRCCS - Istituto Europeo di Oncologia IEO

    Milan, 20141, Italy

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Institut Gustave Roussy, Service de médecine

    Villejuif, 94805, France

  • Instytut Centrum Zdrowia Matki Polki (ICZMP)

    Lodz, 93-338, Poland

  • MD Anderson Cancer Center, Oncology service

    Madrid, 28033, Spain

  • Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland

    Baltimore, Maryland, 21201, United States

  • MedPolonia Sp z oo

    Poznan, 60693, Poland

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • Orszagos Koranyi Pulmonologiai Intezet

    Budapest, 1121, Hungary

  • Ospedale San Luca

    Lucca, 55100, Italy

  • Semmelweis University- Department of Pulmonology

    Budapest, 1083, Hungary

  • Sotiria General Hospital of Chest Diseases, 3rd Department of Internal Medicine, Oncology Unit

    Athens, 115 27, Greece

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University General Hospital of Larissa, Oncology Clinic

    Larissa, 41110, Greece

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20090, Poland

  • Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, raka płuca i chorób wewnętrznych

    Bialystok, 15-540, Poland

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