Durvalumab (MEDI4736) for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
2
Effectiveness
3
Safety
Research Site, Mrozy, Poland
Carcinoma, Non-Small-Cell Lung+1 More
Durvalumab (MEDI4736) - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

This study is evaluating whether a drug called durvalumab can improve survival in people with advanced lung cancer.

See full description

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Durvalumab (MEDI4736) will improve 2 primary outcomes, 10 secondary outcomes, and 1 other outcome in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of 12 months.

12 months
The efficacy of Durvalumab compared to SoC in terms of A Proportion of patients alive and progression free at 12 months from randomization (APF12)
18 months
Proportion of patients alive at 18 months from randomization (OS18)
24 months
Proportion of patients alive at 24 months from randomization (OS24)
4 years
Disease-related symptoms and health-related quality of life in subjects treated with durvalumab compared to SoC using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
The Incidence of Treatment-Emergent Adverse Events assessed by Common Terminology Criteria for Adverse Event (CTCAE) v4.03 for subjects receiving Durvalumab therapy or SoC
The efficacy of Durvalumab compared to SoC in terms of Duration of response (DoR)
The efficacy of Durvalumab compared to SoC in terms of Objective response rate (ORR)
The efficacy of Durvalumab compared to SoC in terms of Progression-free survival after subsequent anticancer therapy (PFS2)
The efficacy of Durvalumab therapy compared to SoC in terms of OS in patients who are at low risk of early mortality (EM)
The efficacy of Durvalumab therapy compared to SoC in terms of Overall Survival (OS) in PD-L1 high patients and in PD-L1 high with low risk of EM population
The efficacy of Durvalumab therapy compared to SoC in terms of Overall Survival (OS) in all randomized patients
The efficacy of Durvalumab therapy compared to SoC in terms of progress-free survival (PFS) in patients with NSCLC
The immunogenicity of durvalumab by measuring the presence of Anti-drug Antibodies

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Arm 2: Standard of Care
Arm 1: Durvalumab

This trial requires 671 total participants across 2 different treatment groups

This trial involves 2 different treatments. Durvalumab (MEDI4736) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Arm 1: Durvalumab
Drug
Anti-PD-L1 monoclonal Antibody monotherapy
Arm 2: Standard of CareStandard of Care Platinum-Based chemotherapy
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: 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 years for reporting.

Closest Location

Research Site - Anaheim, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Aged at least 18 years
Documented evidence of Stage IV NSCLC
No sensitizing EGFR mutation and ALK rearrangement
PD-L1 high expression
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

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

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The most commonly used treatments for [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) are radiotherapy, chemotherapy, surgery, and biogenetic therapy. In advanced stages, radiotherapy may be used alone or with chemotherapy and biogenetic therapy. Survival depends on the type of treatment given depending on the stage of the cancer.

Unverified Answer

What causes carcinoma, non-small-cell lung?

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Carcinoma, non-small-cell, is a complex disease that results from the interaction of multiple etiologic influences, including lifestyle and environmental factors. These factors cannot simply be measured, nor can they be simplified into discrete molecular pathways (and specific genes and proteins) so that these markers may reflect an underlying process.

Unverified Answer

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

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Although surgery and chemotherapy are highly effective for nonsquamous carcinoma, in an institutional referral centre with a high prevalence of locally advanced disease the majority of surgically resected patients can expect to have long-lasting cancer remission or symptom-free survival with chemotherapy. However, only a minority of patients can expect to survive more than 2 years.

Unverified Answer

What is carcinoma, non-small-cell lung?

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Cancers of lung and bronchus are both common diseases with significant financial cost and significant human suffering. A large number of lung and bronchus cancers would not be detected without careful history and physical examination by general physicians and by respiratory physicians as a part of a primary care physician's work. The financial resource spent to screen for lung and bronchial cancer should be balanced with an evaluation of cost-effectiveness.

Unverified Answer

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

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Cancer of the lung is a significant cause of deaths in the United States, representing approximately 8.6% of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) deaths and 18.5% of deaths from lung cancer. Lung carcinoma represents 15.0% of new cases of cancer diagnosed in the United States in 2009. Results from a recent paper will help physicians estimate the future burden of lung cancer on the United States health care system.

Unverified Answer

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

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The most common signs of nonsmall-cell [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer)s are cough, dyspnea, chest pain, hemoptysis, hematochezia, and hemoptysis with hematochezia with or without hematochezia, with or without hemoptysis. The presence of any of these symptoms is significant. Most nonsmall-cell cancers are diagnosed on the basis of symptoms and physical assessment.

Unverified Answer

What is the latest research for carcinoma, non-small-cell lung?

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This review [did] not support recent randomized controlled trials, meta-analyses of pooled data or a guideline incorporating the literature; therefore, the evidence did not support any particular approach that is currently considered to be valid for carcinoma, non-small-cell lung. The most recent reviews (as of 2007) do not provide information in a way that is helpful and complete for clinicians. Further research [into the management of carcinoma, non-small-cell lung is necessary] if we are to improve patient care and outcomes in metastatic cancer.

Unverified Answer

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

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Only one patient at our institution survived for more than 3 years, with a median survival interval between diagnoses of 3.7 years. The survival rates for our patients were 2% for synchronous disease, 21% for metachronous disease, and 28% for patients with Stage I or II disease.

Unverified Answer

What is the primary cause of carcinoma, non-small-cell lung?

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The most common cause of lung carcinoma, non-small-cell lung, is cigarette smoking; however, a significant proportion of all cases would be prevented if smoking were banned.

Unverified Answer

Is durvalumab (medi4736) safe for people?

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Median time to first dose of durvalumab was 20 d (interquartile interval 15-42). Patients who took durvalumab had a shorter duration of the medication-induced flare-up and less nausea when compared with those who did not take durvalumab. Median time to best sustained reduction in tumor size was 34 and 45 d in patients who received 100 and 200 mg of durvalumab, respectively. Because these results are from one small study of patients who received a single dose of 200 mg, and may not be generalizable to all people, further study with larger patient populations is needed to validate these results.

Unverified Answer

What is the average age someone gets carcinoma, non-small-cell lung?

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For the present study, we determined the age of patients who had received treatment for NSCLC and the stage of the disease. The average age of patients was 63 years. Patients of ages 70 years or more had most commonly received treatment. Recent findings of the study are preliminary. To ensure validity, results should be confirmed on a larger population.

Unverified Answer

How quickly does carcinoma, non-small-cell lung spread?

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Although NSCLC has a dismal prognosis, almost all metastatic lesions are found in the lungs. If there are metastases present and the primary tumor proves not completely resected, the possibility of a complete surgical resection of the primary tumor does not appear to be significant, and the patient can expect a better prognosis.

Unverified Answer
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