Durvalumab for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
2
Effectiveness
3
Safety
Research Site, Rotterdam, Netherlands
Carcinoma, Non-Small-Cell Lung+1 More
Durvalumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

This study is evaluating whether a drug may help treat lung cancer.

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Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Lung Neoplasms

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 will improve 3 primary outcomes and 24 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of up to 6 months after last dose.

Week 12
Maximum Plasma concentration (Cmax)
Week 156
ECG QT interval
Day 35
Assessment of AEs by CTCAE v 5.0 as measures of the safety, tolerability and compliance of osimertinib with SoC SBRT therapy
Month 24
Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1
Year 5
Lung cancer mortality
Overall Survival
Time To Progression (TTP)
Time to CNS progression
WHO performance status
Year 5
4-year Progression-Free Survival (4y-PFS) by ICR according to RECIST 1.1 criteria
PFS by ICR using RECIST 1.1
PFS2
Site(s) of disease progression
Year 6
Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC
Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1
Time to progression (TTP) assessed by BICR according to RECIST 1.1
Year 7
Health-related quality of life in patients treated with durvalumab with SoC SBRT compared to placebo with SoC SBRT using the EORTC QLQ-C30
Lung cancer-specific mortality
Overall Survival (OS)
Time from randomisation to second progression (PFS2) as defined by local standard clinical practice
up to 27 months
Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of durvalumab with SoC SBRT compared to placebo with SoC SBRT
Peak Plasma Concentration (Cmax)
Month 3
Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of Durvalumab with SoC SBRT compared to placebo with SoC SBRT
Trough Concentration (Ctrough)
Month 6
Detection of ADA neutralising antibodies titers
up to 6 years
Progression-Free Survival (PFS) assessed by BICR according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC

Trial Safety

Safety Estimate

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

Compared to trials

Trial Design

5 Treatment Groups

SoC SBRT + Placebo Therapy (Main Cohort)
SoC SBRT + Durvalumab Therapy
Placebo group

This trial requires 733 total participants across 5 different treatment groups

This trial involves 5 different treatments. Durvalumab is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

SoC SBRT + Durvalumab TherapySBRT - delivered in 3, 4, 5 or 8 fractions. Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 24 months or until progression or other discontinuation criteria are met.
SoC SBRT + Durvalumab Therapy (Main Cohort)
Drug
SBRT - delivered in 3, 4, 5 or 8 fractions. Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 24 months or until progression or other discontinuation criteria are met.
SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, separate cohort)
Drug
SBRT delivered in 3, 4, 5 or 8 fractions Osimertinib 80mg every day [qd] for oral administration up to 36 months or until progression. Osimertinib treatment should start within 7 to 14 days after completion of SBRT
SoC SBRT + Placebo Therapy (Main Cohort)
Other
SBRT - delivered in 3, 4, 5 or 8 fractions. Placebo (matching placebo for infusion every 4 weeks iv for up to 24 months or until progression or other discontinuation criteria are met.
SoC SBRT + Placebo TherapySBRT - delivered in 3, 4, 5 or 8 fractions. Placebo (matching placebo for infusion every 4 weeks iv for up to 24 months or until progression or other discontinuation criteria are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBRT
2013
Completed Phase 2
~550
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization up to 7 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from randomization up to 7 years for reporting.

Closest Location

Research Site - Chapel Hill, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age ≥18 years
Planned SoC SBRT as definitive treatment
WHO/ECOG PS of 0, 1 or 2
Submission of tumor tissue sample if available
Adequate organ and marrow function required
Patients with central or peripheral lesions are eligible
Staging studies must be done during screening (PET-CT within 10 weeks). show original
You must be aged at least 12 weeks at the time of screening. show original
You have a body weight of more than 30 kilograms. show original
You have a history of metachronous NSCLC and synchronous lesions. 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 is carcinoma, non-small-cell lung?

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Carcinoma, non-small-cell lung is the most common lung tumor in men. More than a quarter of the patients with non-small-cell lung carcinoma died. Symptoms and signs were most often related to bulky tumors. The age of the patient was the main factors for predicting the symptoms and signs associated to non-small-cell lung carcinoma patients.

Unverified Answer

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

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Lung carcinoma is treated primarily based on stage and histomorphopathology. In stage I disease, surgery alone offers the best chance of long-term survival and reduces the chance of developing distant metastases. In stage II disease, surgery does not significantly improve patient survival, but the amount of cancer spread is limited. Radiotherapy or chemoradiotherapy is not normally recommended as first-line treatment unless metastatic spread occurs. Chemotherapy is usually reserved for patients who have developed distant metastasis.

Unverified Answer

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

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Carcinoma, non-small-cell lung may cause weight loss and, less commonly, symptoms such as headache, cough or dyspepsia. The only sign that distinguishes carcinoma, non-small-cell lung from other causes of mass-like symptoms are increased serum levels of tumour markers. Carcinoma, non-small-cell lung may be associated with enlarged lymph nodes.

Unverified Answer

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

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Even when carcinoma, non-small-cell lung was definitively cured, some patients presented after a 5-year followup, with significant residual or recurrent disease. Thus, long-term, patient-directed followup will be important to assess patients' treatment successes. A specific and more effective followup strategy needs to be developed for patients with carcinoma, non-small-cell lung.

Unverified Answer

What causes carcinoma, non-small-cell lung?

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Non-smokers are at a small increase in SCC risk. The large risk differences between Chinese and North Asian and Caucasians may reflect ethnicity-specific differences in smoking habits.

Unverified Answer

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

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Despite the high risk of lung cancer, a substantial proportion of lung cancer cases in the United States are not related to asbestos or tobacco smoking, and in the vast majority of such cases they are attributable to environmental tobacco smoke. The use of available screening and diagnostic tests, such as lung scans, chest x-rays, computed tomography of the lungs, and diagnostic bronchoalveolar lavage could potentially detect cases of NSCLC caused by environmental tobacco smoke. We recommend a comprehensive screening program for all people over 45 years of age.

Unverified Answer

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

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The average age of diagnosis of carcinoma, non-small-cell lung (CSM)-related disease remains remarkably constant at a relatively low age of 80.1 years. The increasing age of lung cancer was almost three-fold greater when compared with the age of people with carcinoma, non-small-cell lung (CSM)-related disease.

Unverified Answer

What are the common side effects of durvalumab?

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Durvalumab is a strong inhibitor of PD-L1, a new class of therapeutic antibody. Because of their common side effects, PD-L1-based antibodies are only prescribed after the exclusion of alternative hypotheses in the development of an immunotherapy, using biomarkers to predict the likelihood of responses.

Unverified Answer

What are the latest developments in durvalumab for therapeutic use?

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In May 2014, US Food and Drug Administration granted orphan drug designation for durvalumab and expanded the dosage and the indication to more advanced/uncontrolled disease. In November 2014, US FDA approved in adults with metastatic non-small cell lung cancer (NSCLC) with disease progression following platinum-based chemotherapy (PFS > 6 months). In September 2016 the US FDA approved in adults with locally advanced or metastatic pancreatic cancer (PDC) with disease progression following definitive chemoradiation (dCRT) (post-chemoradiation radiotherapy) followed by a chemotherapy regimen. This approval was based on the SYNTAX study with a survival advantage of 4.

Unverified Answer

Does durvalumab improve quality of life for those with carcinoma, non-small-cell lung?

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In patients with metastatic NSCLC, no clinically meaningful differences were seen between DTG and durvalumab in the QoL parameters measured (VAS pain/nausea/vomiting, overall pain). Patients with a high baseline VAS and VAS pain/nausea scores were most likely to encounter some change.

Unverified Answer

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

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It is difficult to come up with an answer from the last 3 years to the question 'What is the latest research for carcinoma, non-small-cell lung?' Because of the small number of reports cited, and due to the limited amount of recent research performed, it is difficult to make any conclusions. More randomized controlled trials are needed, particularly for the treatment of nonfunctioning neuroendocrine tumors.

Unverified Answer

Is durvalumab safe for people?

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Durvalumab was well tolerated and demonstrated strong anti-tumor activity in people with various solid tumors. It resulted in substantial and durable reductions in disease burden and was well tolerated.

Unverified Answer
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