RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the effects of adding the study drug NKTR-255 to the standard drug durvalumab after chemotherapy and radiation. It is for adults with non-small cell lung cancer that has spread nearby.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be 18 or older.
  • A tissue test must show non-small cell lung cancer.
  • You must understand the study and sign a consent form before any study procedures.
  • Your cancer treatment must aim to cure the cancer.
  • You must have no other current cancer, except low-risk prostate cancer or basal cell skin cancer.
  • If you had cancer before, you must not have had active cancer treatment in the past 3 months. Prior cancer survivors may qualify after treatment aimed at a cure, at least 1 year with no signs of that cancer, and a low risk of it returning.
  • Your liver and kidney blood tests must meet the study's limits.
  • You must be able to care for yourself and be out of bed or a chair for more than half of your waking hours.

Who can't join

  • You have HIV or certain conditions that weaken the immune system; hepatitis B or C, unless hepatitis C treatment has kept the virus cleared; or certain blood cancers with many T cells or NK cells, which are types of immune cells.
  • You have a serious autoimmune disease, where the body attacks itself, Crohn's disease, ulcerative colitis, or another inflammatory disease.
  • You have a serious health problem, including an active infection needing treatment, or another condition or past treatment that the study doctor thinks could make the study unsafe or affect its results.
  • You have a known or suspected allergy to an ingredient in the study drug, have already joined this study, or are pregnant.
  • You have had repeat radiation to the treatment area, or major surgery within 4 weeks before joining and have not recovered.
  • You have received anti-PD-1 or anti-PD-L1 drugs, which are immune treatments, or IL-2 or IL-5.
  • You have serious disease affecting the tissue around the lungs' air sacs, or active lung inflammation not caused by infection during chemotherapy and radiation that has not improved to mild or less.
  • You had grade 4 side effects, which are life-threatening, during chemotherapy and radiation that have not improved to mild or less by the end of treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

TX

  • M D Anderson Cancer Center · Houston, TX 77030Steven H. Lin, MD · Study contactSteven H. Lin, MD · Principal investigatorMore trials in Houston