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

NCT05632809 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2021-0925NCI-2022-09970
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival time distribution

  through study completion; an average of 1 year

Study Arms (1)

NKTR-255 combination (Durvalumab)

EXPERIMENTAL

Participants will receive vein over about 30 minutes. Participants receive the first dose within 72 hours (3 days) after you complete CRT and the second dose at 3 weeks after you complete CRT. Then, you will receive NKTR-255 one (1) time every 4 weeks after that for up to 1 year. Durvalumab Participants will receive durvalumab by vein over about 30 minutes. You will receive the first dose at 3 weeks after you complete CRT therapy. Then, you will receive durvalumab one (1) time every 4 weeks after that for up to 1 year

Drug: NKTR-255; Drug: Durvalumab

Interventions

NKTR-255 DRUG

Given by IV (vein)

NKTR-255 combination (Durvalumab)

Durvalumab DRUG

Given by IV (vein)

NKTR-255 combination (Durvalumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Nektar Therapeutics: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Lung Neoplasms

Interventions

NKTR-255; durvalumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Steven Lin, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven H. Lin, MD

CONTACT

(713) 563-8490; shlin@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: January 10, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)