New drug combo shows promise for tough lung cancers

NCT ID NCT04681131

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tested a new drug called BA3011, alone or with an immunotherapy, in 85 adults with advanced non-small cell lung cancer that had worsened after standard treatments. The goal was to see if the drug could shrink tumors and how safe it was. The study is now complete, and results will show whether this approach deserves further testing.

What this could mean

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

Active substance
BA3011 (a targeted drug that seeks out and kills cancer cells) alone or with a PD-1 inhibitor (an immunotherapy)
What this could lead to
If successful, this could provide a new treatment option for people with advanced lung cancer who have stopped responding to standard therapies.
What could go wrong
This is a small, early-phase trial (85 people) with no control group, so results may not be definitive. Side effects from the drug combination could be significant.

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

85 people

The number who actually took part.

Started

Mar 2021

Finished

Jul 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.

Inclusion Criteria: * Patients must have measurable disease. * Age ≥ 18 years * Adequate renal function * Adequate liver function * Adequate hematological function * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of at least three months. Exclusion Criteria: * Patients must not have clinically significant cardiac disease. * Patients must not have known non-controlled CNS metastasis. * Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload. * Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study. * Patients must not have had major surgery within 4 weeks before first BA3011 * Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C. * Patients must not be women who are pregnant or breast feeding.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • "IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano."

    Genoa, Liguria, 16132, Italy

  • American Institute of Research

    Whittier, California, 90603, United States

  • Augusta University - Georgia Cancer Center

    Augusta, Georgia, 30912, United States

  • Baptist Health Systems

    Lexington, Kentucky, 40503, United States

  • Bioclinic Thessaloniki

    Thessaloniki, 546 22, Greece

  • California Research Institute

    Los Angeles, California, 90027, United States

  • Catalan Institute of Oncology, Hospital Duran i Reynals

    Barcelona, Catalonia, 08908, Spain

  • Cedars-Sinai

    Los Angeles, California, 90048, United States

  • City of Hope - Duarte

    Duarte, California, 91010, United States

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89014, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • European Institute of Oncology (IEO), IRCCS

    Milan, 20141, Italy

  • European Interbalkan Medical Center

    Thessaloniki, 570 01, Greece

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374, United States

  • Florida Cancer Specialist

    St. Petersburg, Florida, 33705, United States

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401, United States

  • Florida Cancer Specialists & Research Institute

    Fleming Island, Florida, 32003, United States

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida, 33916, United States

  • Gabrail Cancer Research Center

    Canton, Ohio, 44718, United States

  • Hematology/Oncology Clinic

    Baton Rouge, Louisiana, 70809, United States

  • Henry Dunant Hospital Center

    Athens, 115 26, Greece

  • Hong Kong United Oncology Centre

    Kowloon, Hong Kong

  • Hospital San Giuseppe Moscati

    Avellino, 83100, Italy

  • Hospital Universitario Virgen de Valme

    Seville, Andalusia, 41014, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041, Spain

  • Hospital del Mar

    Barcelona, Catalonia, 08003, Spain

  • ICON Cancer Centre

    Hong Kong, Hong Kong

  • Institute of Genetics and Immunology GENIM

    Lublin, Lublin Voivodeship, 20-609, Poland

  • Integrated University Hospital of Verona

    Verona, 37126, Italy

  • Kaoshiung Chang Gung Memorial Hospital

    Kaohsiung City, Taiwan

  • MD Anderson

    Houston, Texas, 77030, United States

  • MED-Polonia, Sp. z o.o. (LLC)

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • Maria Sklodowska-Curie - National Research Institute of Oncology

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230, United States

  • Medical University of South Carolina- Hollings Cancer Center

    Charleston, South Carolina, 29407, United States

  • Metropolitan Hospital Perseus Healthcare Group SA

    Piraeus, 185 47, Greece

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Norton Cancer Institute, Brownsboro Hospital Campus

    Louisville, Kentucky, 40241, United States

  • OptumCare Cancer Care

    Las Vegas, Nevada, 89169, United States

  • Polish Mother's Memorial Hospital-Research Institute

    Lodz, Łódź Voivodeship, 93-338, Poland

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Roswell Park

    Buffalo, New York, 14263, United States

  • Santa Maria delle Croci Hospital of Ravenna

    Ravenna, 48121, Italy

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Specialistic Oncologic Hospital NU-MED

    Tomaszów Mazowiecki, Łódź Voivodeship, 97-200, Poland

  • Taichung Veterans General Hospital

    Taichung, Taiwan

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • The Lindner Research Center at the Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • USC Norris

    Los Angeles, California, 90033, United States

  • University Hospital 12 de Octubre

    Madrid, Madrid, 28041, Spain

  • University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center

    Irvine, California, 92868, United States

  • University of California, San Diego (UCSD) - Moores Cancer Center

    San Diego, California, 92093, United States

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Michigan Comprehensive Cancer Center

    Detroit, Michigan, 48202, United States

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