New hope for lung cancer patients who failed immunotherapy: targeted drug combo trial launches
NCT ID NCT03334617
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with advanced non-small cell lung cancer whose disease got worse after treatment with immunotherapy (anti-PD-1/PD-L1 drugs). It tests several different drug combinations, chosen based on the unique markers (biomarkers) in each person's tumor. The goal is to see which treatments are safe and effective for different types of lung cancer. About 528 adults are taking part in this phase 2 trial.
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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
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528 people
The number who actually took part.
- Started
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Dec 2017
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- 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 to 99 years
- 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: * At least 18 years of age at the time of signing the informed consent form. * Participant must have histologically or cytologically confirmed metastatic or locally advanced and recurrent non-small-cell lung cancer (NSCLC) which is progressing. * Participants eligible for second- or later-line therapy, who must have received an anti-programmed cell death protein-1 (PD-1)/programmed death-ligand 1 (PD-L1) containing therapy and a platinum-doublet regimen for locally advanced or metastatic NSCLC either separately or in combination. Prior durvalumab is acceptable. The participant must have had disease progression on a prior line of anti-PD-1/PD-L1 therapy. * Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performance status of 0 to 1, and a minimum life expectancy of 12 weeks. * Participant must have at least 1 lesion that can be accurately measured. A previously irradiated lesion can be considered a target lesion if the lesion has clearly progressed. * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal participants. Exclusion Criteria: * Participants whose tumour samples have targetable alterations in epidermal growth factor receptor (EGFR) and/or anaplastic lymphoma kinase (ALK) at initial diagnosis are excluded. In addition, participants whose tumour samples are known to have targetable alterations in ROS1, BRAF, MET or RET, are to be excluded. * Active or prior documented autoimmune or inflammatory disorders. * Active infection including tuberculosis, hepatitis B (known positive hepatitis B virus \[HBV\] surface antigen \[HBsAg\] result), hepatitis C, or human immunodeficiency virus (positive human immunodeficiency virus \[HIV\] 1/2 antibodies). * Female participant who are pregnant or breastfeeding, or male or female participants of reproductive potential who are not willing to employ effective birth control. * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients, or history of severe hypersensitivity reactions to other monoclonal antibodies. * Participant has spinal cord compression or symptomatic brain metastases. * Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Participants may receive treatment with bisphosphonates or receptor activator of nuclear factor kappa-Β ligand (RANKL) inhibitors for the treatment of bone metastases. * History of active primary immunodeficiency.
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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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Research Site
Duarte, California, 91010, United States
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Research Site
Fullerton, California, 92835, United States
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Research Site
La Jolla, California, 92093, United States
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Research Site
Los Angeles, California, 90095, United States
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Research Site
Washington D.C., District of Columbia, 20016, United States
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Research Site
Chicago, Illinois, 60637, United States
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Research Site
Baltimore, Maryland, 21224, United States
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Research Site
Baltimore, Maryland, 21287, United States
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Research Site
Boston, Massachusetts, 02215, United States
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Research Site
St Louis, Missouri, 63110, United States
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Research Site
New York, New York, 10032, United States
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Research Site
Philadelphia, Pennsylvania, 19111, United States
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Research Site
Pittsburgh, Pennsylvania, 15232, United States
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Research Site
Nashville, Tennessee, 37203, United States
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Research Site
Nashville, Tennessee, 37212, United States
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Research Site
Houston, Texas, 77030, United States
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Research Site
Fairfax, Virginia, 22031, United States
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Research Site
Innsbruck, 6020, Austria
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Research Site
Salzburg, 5020, Austria
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Research Site
Vienna, 1140, Austria
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Research Site
Vienna, 1210, Austria
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Research Site
Edmonton, Alberta, T6G 1Z2, Canada
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Research Site
Brampton, Ontario, L6R 3J7, Canada
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Research Site
Ottawa, Ontario, K1H 8L6, Canada
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Research Site
Toronto, Ontario, M5G 2M9, Canada
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Research Site
Montreal, Quebec, H2X 3E4, Canada
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Research Site
Bordeaux, 33076, France
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Research Site
Nantes, 44093, France
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Research Site
Paris, 75877, France
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Research Site
Villejuif, 94800, France
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Research Site
Berlin, 12203, Germany
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Research Site
Esslingen a.N., 73730, Germany
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Research Site
Großhansdorf, 22927, Germany
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Research Site
Heidelberg, 69126, Germany
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Research Site
Haifa, 31096, Israel
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Research Site
Kfar Saba, 95847, Israel
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Research Site
Petah Tikva, 49100, Israel
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Research Site
Ramat Gan, 5265601, Israel
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Research Site
Seoul, 03080, South Korea
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Research Site
Seoul, 05505, South Korea
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Research Site
Seoul, 6351, South Korea
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Research Site
Barcelona, 08036, Spain
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Research Site
Madrid, 28007, Spain
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Research Site
Madrid, 28034, Spain
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Research Site
Seville, 41009, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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?