New drug combo shows promise for tough lung cancers
NCT ID NCT04681131
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
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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
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Mar 2021
- Finished
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Jul 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer are added.
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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
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"IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano."
Genoa, Liguria, 16132, Italy
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American Institute of Research
Whittier, California, 90603, United States
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Augusta University - Georgia Cancer Center
Augusta, Georgia, 30912, United States
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Baptist Health Systems
Lexington, Kentucky, 40503, United States
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Bioclinic Thessaloniki
Thessaloniki, 546 22, Greece
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California Research Institute
Los Angeles, California, 90027, United States
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Catalan Institute of Oncology, Hospital Duran i Reynals
Barcelona, Catalonia, 08908, Spain
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Cedars-Sinai
Los Angeles, California, 90048, United States
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City of Hope - Duarte
Duarte, California, 91010, United States
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Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
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Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89014, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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European Institute of Oncology (IEO), IRCCS
Milan, 20141, Italy
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European Interbalkan Medical Center
Thessaloniki, 570 01, Greece
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FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374, United States
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Florida Cancer Specialist
St. Petersburg, Florida, 33705, United States
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Florida Cancer Specialists
West Palm Beach, Florida, 33401, United States
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Florida Cancer Specialists & Research Institute
Fleming Island, Florida, 32003, United States
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Florida Cancer Specialists & Research Institute
Fort Myers, Florida, 33916, United States
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Gabrail Cancer Research Center
Canton, Ohio, 44718, United States
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Hematology/Oncology Clinic
Baton Rouge, Louisiana, 70809, United States
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Henry Dunant Hospital Center
Athens, 115 26, Greece
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Hong Kong United Oncology Centre
Kowloon, Hong Kong
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Hospital San Giuseppe Moscati
Avellino, 83100, Italy
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Hospital Universitario Virgen de Valme
Seville, Andalusia, 41014, Spain
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Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
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Hospital del Mar
Barcelona, Catalonia, 08003, Spain
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ICON Cancer Centre
Hong Kong, Hong Kong
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Institute of Genetics and Immunology GENIM
Lublin, Lublin Voivodeship, 20-609, Poland
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Integrated University Hospital of Verona
Verona, 37126, Italy
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Kaoshiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
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MD Anderson
Houston, Texas, 77030, United States
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MED-Polonia, Sp. z o.o. (LLC)
Poznan, Greater Poland Voivodeship, 60-693, Poland
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Maria Sklodowska-Curie - National Research Institute of Oncology
Warsaw, Masovian Voivodeship, 02-781, Poland
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Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
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Medical University of South Carolina- Hollings Cancer Center
Charleston, South Carolina, 29407, United States
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Metropolitan Hospital Perseus Healthcare Group SA
Piraeus, 185 47, Greece
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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NYU Langone Health
New York, New York, 10016, United States
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National Cheng Kung University Hospital
Tainan, Taiwan
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National Taiwan University Hospital
Taipei, Taiwan
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Norton Cancer Institute, Brownsboro Hospital Campus
Louisville, Kentucky, 40241, United States
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OptumCare Cancer Care
Las Vegas, Nevada, 89169, United States
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Polish Mother's Memorial Hospital-Research Institute
Lodz, Łódź Voivodeship, 93-338, Poland
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Queen Mary Hospital
Hong Kong, Hong Kong
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Roswell Park
Buffalo, New York, 14263, United States
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Santa Maria delle Croci Hospital of Ravenna
Ravenna, 48121, Italy
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Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
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Specialistic Oncologic Hospital NU-MED
Tomaszów Mazowiecki, Łódź Voivodeship, 97-200, Poland
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Taichung Veterans General Hospital
Taichung, Taiwan
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Taipei Veterans General Hospital
Taipei, Taiwan
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The Lindner Research Center at the Christ Hospital
Cincinnati, Ohio, 45219, United States
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UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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USC Norris
Los Angeles, California, 90033, United States
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University Hospital 12 de Octubre
Madrid, Madrid, 28041, Spain
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University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center
Irvine, California, 92868, United States
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University of California, San Diego (UCSD) - Moores Cancer Center
San Diego, California, 92093, United States
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
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University of Kentucky
Lexington, Kentucky, 40536, United States
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University of Michigan Comprehensive Cancer Center
Detroit, Michigan, 48202, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?
- Two-Drug combo takes aim at Hard-to-Treat lung cancer