Durvalumab for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
1
Effectiveness
1
Safety
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, OH
Carcinoma, Non-Small-Cell Lung+2 More
Durvalumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

This study is evaluating whether a combination of radiation and a drug may be more effective than radiation alone for treating lung cancer.

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Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Lung Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Durvalumab will improve 1 primary outcome and 2 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Up to 30 days following end of treatment.

Day 30
Feasibility of intervention defined by number of participants receiving full course of RT treatment and minimum of two doses of Durvalumab
Number of participants with Adverse Events according to CTCAE v5.0
Safety of intervention as defined by number of participants with Dose Limiting Toxicities (DLT) between first dose of Durvalumab and 30 days following completion of radiotherapy.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
Arm 2 - 69 CGyE in 23 fractions followed by expansion cohort a

This trial requires 27 total participants across 2 different treatment groups

This trial involves 2 different treatments. Durvalumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Arm 2 - 69 CGyE in 23 fractions followed by expansion cohort aProton based external beam radiation therapy with concurrent Durvalumab starting one week before RT. Radiation will follow dose escalation scheme: 69 CGyE in 23 fractions (3+3 participants, 3-6 total) Followed by expansion cohort at identified RP2 dose (12 participants)
Arm 1 - 60 CGyE in 20 fractionsProton based external beam radiation therapy with concurrent Durvalumab starting one week before RT. Radiation will follow dose escalation scheme: 60 CGyE in 20 fractions (3+3 participants, 3-6 total)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days following end of treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 30 days following end of treatment for reporting.

Closest Location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Non-Small-Cell Lung or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Any tumor with any level of PD-L1 expression is allowed (including 0% to 100%, or unknown at time of study enrollment). show original
Patients who are not candidates for surgery or who refuse surgery may be deemed unresectable for any reason, including tumor location, tumor characteristics, operative risks, participant lung function, participant age or medical comorbidity. show original
The subject had to have pulmonary function testing within 365 days of registration to confirm that they had sufficient lung function show original
indicates A patient with an ECOG performance status of 0-2 is considered to have a good performance status. show original
Body Weight >30kg
The text implies that the patient must have known that he or she had a life expectancy of at least 12 weeks in order for the surgery to be covered. show original
The cancer must be confirmed to be NSCLC by biopsy within 90 days of registration. show original
The AJCC 8th Stage IIA-IIIC staging system is used to describe the extent of a cancer show original
The participant is not a candidate for or able to tolerate standard cisplatinum based doublet concurrent chemoradiation therapy, or has refused chemotherapy for any reason. show original
A person's haemoglobin level is considered high if it is 9.0 g/dL or above. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes carcinoma, non-small-cell lung?

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The main cause of carcinoma of the lung is smoking. However, other factors can also enhance [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) risk, for example air pollution, which is the second most common cause of death from cancer. Smoking causes a number of mutations in the lung epithelium. The carcinogenic process is complex.

Unverified Answer

What are common treatments for carcinoma, non-small-cell lung?

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Recent findings reveals that, in this population of patients with carcinoma, non-small-cell lung (NSCLC), the preferred treatment strategy is surgery for early-stage (I-IIIA) NSCLC followed by adjuvant platinum-based chemotherapy and/or taxane-containing chemotherapy, although in recent years platinum-containing chemotherapy has shown to be only equivalent to taxane chemotherapy as the second-line treatment for early-stage, locally advanced NSCLC. Radiation therapy following surgery is not indicated, as the evidence was inconclusive.

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How many people get carcinoma, non-small-cell lung a year in the United States?

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Carcinoma, non-small cell lung is a common disease. More than 1.1 million U.S. cancer deaths are due to lung malignancy annually. This may be due to the fact that the overall longevity of people in the United States is declining.

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What is carcinoma, non-small-cell lung?

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Results from a recent clinical trial, there was no interaction between the genotype of the RAS oncogene codon 12 SNP and NQO1 SNP with the clinical characteristics of lung cancer, such as histological type, tumor size and TNM stage when assessing the gene polymorphism in the patients' DNA sequences. Furthermore, the results indicated that the patients with the homozygous genotype GG of the NQO1 SNP of the C/T polymorphism of exon 2-5 could be treated by the lung carcinoma (with low-stage), and therefore, the patients with the C/C genotype were not suitable candidates for lung cancer treatment.

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Can carcinoma, non-small-cell lung be cured?

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TNF-alpha mediated cytokine signaling is important for tumor cell proliferation and survival in a process that is dependent on tumor cell type. Thus, targeting the NF-kappaB pathway can lead to clinical remission of carcinoma, non-small-cell lung in some patients. It deserves further study as a potential therapeutic target.

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What are the signs of carcinoma, non-small-cell lung?

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Symptoms of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) should be investigated, especially if they mimic asthma, or if they include: breathlessness, coughing and hemoptysis. A chest X-ray is required in patients presenting with complaints of cancer or in those with previous or family history of cancer.

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Does carcinoma, non-small-cell lung run in families?

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In addition to well established risk factors for [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer), the presence of a family history of cancer increased the risk to about 30 times. When an individual from a high-risk family or has a family history, follow-up with lung cancer genetic testing should be conducted.

Unverified Answer

Who should consider clinical trials for carcinoma, non-small-cell lung?

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There are many reasons to trial for lung cancer; even if you fit into any one category, there's still something to work on. Consideration is being given to all patients irrespective of their characteristics. If you are an NSCLC patient and a clinical trial is going to occur, there's still something to work on. To make yourself a part of this clinical trial, visit Power (power).

Unverified Answer

What is durvalumab?

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Durvalumab is a humanized monoclonal antibody that targets the programmed death receptor 1 (PD-1). One study found that those who were treated with durvalumab for metastatic or recurrent non-small cell [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) were 35% more likely to have a response than those receiving conventional therapy. Durvalumab is approved for cancer treatment by the FDA only when used in combination with PD-1 inhibitors. These drugs consist of nivolumab, pembrolizumab, and pomalidomide. For any given cancer, PD-1 inhibitors are thought to activate the immune system to help cure all cancer patients.

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Have there been other clinical trials involving durvalumab?

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Given the current market situation for anticancer drugs, many patients and their physicians were anxious about the development of new agents. Durvalumab appears to be one of the most attractive agents.

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What are the chances of developing carcinoma, non-small-cell lung?

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The chances of developing carcinoma and [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) in the future are much lower than those of a person who did not survive cancer or lung cancer. This means that [survivors of cancer or lung cancer should monitor their health carefully as they age, because they are at higher risk of lung cancer and can develop it more easily than their non-survivor friends and family members (http://www.healthspan.com/healthy_lifestyle/lung_cancer/lung_cancer.htm)].

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What is the survival rate for carcinoma, non-small-cell lung?

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The 5-year survival and 10-year survival rates in our study population with carcinoma, non-small-cell lung were 53.6% and 23.3%, respectively. Survivors with cancer, non-small-cell lung have better survival than non-survivors with the disease. A lower survival rate is associated with older (over 55 years) age.

Unverified Answer
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