RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-10

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05632809

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 current malignancies at other sites, except for adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors who have undergone potentially curative therapy for a prior malignancy who have no evidence of that disease for 5 years 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	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.

Inclusion Criteria

Exclusion 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 current malignancies at other sites, except for adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors who have undergone potentially curative therapy for a prior malignancy who have no evidence of that disease for 5 years 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

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.

Contacts and Locations

Study Contact

Steven H. Lin, MD

CONTACT

(713) 563-8490

shlin@mdanderson.org

Principal Investigator

Steven Lin, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Steven Lin, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-10

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2023-01-10

Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

Lung Cancer