What side effects are associated with this type of intervention?

Common treatments for lung cancer, particularly those involving immune system modulation and PD-L1 inhibition, such as Durvalumab, often result in a range of side effects. These can include fatigue, nausea, increased liver function tests, and immune-related adverse events like pneumonitis, colitis, and dermatitis. Combination therapies with chemotherapy can lead to higher rates of severe adverse events, including neutropenia, anemia, and thrombocytopenia. Specific to Durvalumab, patients may experience infusion-related reactions and immune-mediated side effects affecting various organs.

What prior FDA approvals exist?

Several immune checkpoint inhibitors have received FDA approval for the treatment of lung cancer. Durvalumab, a PD-L1 inhibitor, is approved for patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) following chemoradiotherapy. Pembrolizumab, another PD-1 inhibitor, is approved for first-line treatment of metastatic NSCLC with high PD-L1 expression. Atezolizumab, a PD-L1 inhibitor, is approved in combination with chemotherapy for first-line treatment of metastatic NSCLC. These approvals highlight the role of immune modulation in lung cancer treatment, similar to the investigational combination of NKTR-255 and Durvalumab.

What other types of research exist?

Promising alternatives to NKTR-255 and Durvalumab for lung cancer patients include Pembrolizumab (PD-1 inhibitor) and Atezolizumab (PD-L1 inhibitor), both of which have shown improved overall survival in clinical trials. Additionally, Nivolumab combined with Ipilimumab (CTLA-4 inhibitor) is another effective option, particularly for patients with metastatic disease. These alternatives offer different mechanisms of action and toxicity profiles, providing more options for personalized treatment plans.

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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 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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

Do I qualify?Apply below to find out

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.

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

Durvalumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05632809 — Phase 2

Lung Cancer Research Study Groups: NKTR-255 combination (Durvalumab)

Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT05632809 — Phase 2

Durvalumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05632809 — Phase 2

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