New combo aims to boost immune cells after lung cancer therapy
NCT ID NCT05632809
First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times
Summary
This study tests whether adding the investigational drug NKTR-255 to the standard immunotherapy durvalumab can help restore immune cells after chemoradiation in people with advanced non-small cell lung cancer. About 39 adults will receive the combination and be followed for overall survival. The goal is to improve long-term disease control.
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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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About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: 1. Age 18 years or older 2. Histologic diagnosis of non-small cell lung cancer 3. Written consent obtained before initiation of any study-related procedures 4. Definitive cancer treatment intent 5. Absence of concurrent malignancies at other sites, except low risk prostate cancer and basal cell of the skin. Participants with prior cancers should not be receiving active cancer treatment within the past 3 months. Cancer survivors who have undergone potentially curative therapy for a prior malignancy who have no evidence of that disease for 1 year and who are deemed at low risk for recurrence are eligible for the study. 6. Adequate liver (AST, ALT, Alk Phos, and Tbili \<2 fold upper limit) and kidney function (Cr \< 2.5 limit of normal and Cr clearance \>30) 7. ECOG 0-2 Exclusion Criteria: Subjects are to be excluded from the study if any of the following conditions apply: 1. HIV infection, cellular immune deficiencies, hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies 2. Prior diagnosis of hepatitis B or C (unless anti-hepatitis C therapy has produced a sustained virologic response); 3. History of clinically significant autoimmune disease, Crohn's disease, ulcerative colitis, or inflammatory disease. 4. Serious concomitant disorder, including active systemic infection requiring treatment, as judged by the Investigator. 5. Known or suspected hypersensitivity to any component of the investigational product 6. Recurrent radiation to the treatment site 7. Prior major surgery within 4 weeks of enrollment from which the patient has not recovered 8. Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results 9. Previous enrollment in this study 10. Pregnancy: a female subject defined as a WOCBP who has a positive urine pregnancy test (e.g. within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 11. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody. 12. Patients must be capable of understanding and providing a written informed consent. 13. Patients with leukemias or lymphomas with T cell/histiocyte or NK cell rich component(s) and other variants not otherwise specified that contain high numbers of T or NK cells. 14. Evidence of clinically significant interstitial lung disease or active noninfectious pneumonitis during the course of chemoradiation that is unresolved to ≤ grade 1. 15. Patients with grade 4 toxicities during chemoradiation not resolved to grade ≤ 1 by the end of chemoradiation. 16. Prior exposure to IL-2 or IL-5.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Can an Anti-Fibrotic drug shield lungs from radiation after immunotherapy?
- Breath-Tracking sensor aims to sharpen lung cancer scans
- App aims to catch a hidden radiotherapy side effect