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

Recruiting now · Phase 2

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT05632809

Run by

M.D. Anderson Cancer Center

People needed

39

Starts

2023-01-10

Expected to finish

2027-12-31

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Histologic diagnosis of non-small cell lung cancer
• Written consent obtained before initiation of any study-related procedures
• Definitive cancer treatment intent
• 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.
• 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)
• ECOG 0-2

You may not qualify if…

• Subjects are to be excluded from the study if any of the following conditions apply:
• HIV infection, cellular immune deficiencies, hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies
• Prior diagnosis of hepatitis B or C (unless anti-hepatitis C therapy has produced a sustained virologic response);
• History of clinically significant autoimmune disease, Crohn's disease, ulcerative colitis, or inflammatory disease.
• Serious concomitant disorder, including active systemic infection requiring treatment, as judged by the Investigator.
• Known or suspected hypersensitivity to any component of the investigational product
• Recurrent radiation to the treatment site
• Prior major surgery within 4 weeks of enrollment from which the patient has not recovered
• Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results
• Previous enrollment in this study
• 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.
• Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
• Patients must be capable of understanding and providing a written informed consent.
• 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.
• Evidence of clinically significant interstitial lung disease or active noninfectious pneumonitis during the course of chemoradiation that is unresolved to ≤ grade 1.
• Patients with grade 4 toxicities during chemoradiation not resolved to grade ≤ 1 by the end of chemoradiation.
• Prior exposure to IL-2 or IL-5.

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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