RecruitingPhase 2NCT05632809
Official study title

REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)

Study summary

To learn about the effects of the investigational drug NKTR-255 in combination with the standard drug durvalumab on locally advanced NSCLC when given after CRT.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNKTR-255 and Durvalumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 29, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?M.D. Anderson Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
M.D. Anderson Cancer Center
Interventions being studied
Drug: NKTR-255; Drug: Durvalumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • M D Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 29, 2026. Always confirm current availability with the study team.

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