Your session is about to expire
← Back to Search
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 up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing NKTR-255 and durvalumab in patients with advanced lung cancer who have had previous treatment. The goal is to boost their immune system to better fight the cancer. Durvalumab has shown survival benefits for patients after their initial treatment.
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.
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.
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
NKTR-255
2020
Completed Phase 2
~60
Durvalumab
2017
Completed Phase 2
~3750
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for lung cancer include immune system modulation and PD-L1 inhibition. Immune system modulators, like NKTR-255, enhance the body's natural immune response by activating and expanding natural killer (NK) cells and memory CD8+ T cells, which are crucial for targeting and destroying cancer cells.
PD-L1 inhibitors, such as Durvalumab, block the PD-L1 protein on cancer cells from binding to the PD-1 receptor on T cells, preventing the 'off' signal that allows cancer cells to evade immune detection. These treatments are significant for lung cancer patients as they harness the body's immune system to fight cancer more effectively, potentially leading to improved survival rates and better disease management.
Comparative beneficiary effects of immunotherapy against chemotherapy in patients with advanced NSCLC: Meta-analysis and systematic review.
Comparative beneficiary effects of immunotherapy against chemotherapy in patients with advanced NSCLC: Meta-analysis and systematic review.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,059 Previous Clinical Trials
1,800,629 Total Patients Enrolled
Nektar TherapeuticsIndustry Sponsor
58 Previous Clinical Trials
10,277 Total Patients Enrolled
Steven Lin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
610 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.
Share this study with friends
Copy Link
Messenger