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Checkpoint Inhibitor
NKTR-255 + Durvalumab for Lung Cancer
Phase 2
Recruiting
Led By Steven Lin, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial will investigate if a new drug combined with a standard drug can help treat lung cancer after radiation therapy.
Who is the study for?
This trial is for adults over 18 with non-small cell lung cancer (NSCLC) who intend to undergo definitive cancer treatment, have an ECOG performance status of 0-2, and proper liver and kidney function. Participants must not have other current malignancies except certain skin cancers or a history of another cancer cured over five years ago without recurrence.Check my eligibility
What is being tested?
The study tests the effects of NKTR-255 combined with durvalumab on NSCLC after chemoradiotherapy (CRT). NKTR-255 is investigational, while durvalumab is standard care. The goal is to see how well these drugs work together following CRT in advanced lung cancer cases.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with immunotherapy such as fatigue, possible autoimmune responses where the body attacks its own cells, infusion-related reactions, and issues affecting organs like the liver or lungs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival time distribution
Trial Design
1Treatment groups
Experimental Treatment
Group I: NKTR-255 combination (Durvalumab)Experimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
NKTR-255
2020
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,437 Total Patients Enrolled
Nektar TherapeuticsIndustry Sponsor
58 Previous Clinical Trials
10,303 Total Patients Enrolled
Steven Lin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
550 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious illnesses or infections that need treatment.I have been diagnosed with non-small cell lung cancer.I have received radiation at the same site more than once.My leukemia or lymphoma is rich in T cells or NK cells.I have had hepatitis B or C but am cured of hepatitis C.I have been treated with IL-2 or IL-5 before.My liver and kidney tests are within normal limits.I have been treated with drugs targeting PD-1 or PD-L1 before.I have a history of significant autoimmune or inflammatory disease.My treatment is aimed at curing my cancer.I can understand and sign a consent form.I am 18 years old or older.I am able to care for myself and move around.I have no other cancers except for treated skin cancer or have been cancer-free from another type for 5 years.I have a condition that weakens my immune system.I had severe side effects from cancer treatment that did not improve.I had major surgery less than 4 weeks ago and haven't fully recovered.I don't have severe lung issues from past treatments.
Research Study Groups:
This trial has the following groups:- Group 1: NKTR-255 combination (Durvalumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new subjects being brought into this experiment currently?
"Clinicaltrials.gov communicates that this clinical trial is no longer actively seeking patients, as the study was initially posted on April 30th 2023 and last updated November 21st 2022. Notwithstanding, there are 395 other medical trials presently recruiting participants."
Answered by AI
Has the FDA certified NKTR-255 combination (Durvalumab) for medical use?
"There is some data suggesting NKTR-255 combination (Durvalumab) can provide a degree of safety, thus it earned a score of 2. However, there is not yet evidence to support its efficacy in this Phase 2 clinical trial."
Answered by AI
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