Durvalumab for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
1
Effectiveness
1
Safety
Research Site, St.Petersburg, Russian Federation
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 new drug can improve the survival of people with lung cancer.

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Eligible Conditions

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

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Durvalumab will improve 1 primary outcome and 6 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of From Cycle 1 Day 1 until Cycle 7 Day 1 (each cycle is 28 days) and every 12 weeks thereafter until 3 months following treatment discontinuation.

Approximately 24 months
Objective Response Rate (ORR)
Month 42
Overall Survival (OS)
Month 3
Blood concentration of durvalumab and novel oncology therapies
Month 6
Frequency of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies
Month 3
Assessment of AEs by CTCAE v5.0
Month 24
Duration of Response (DoR)
Month 24
Progression Free Survival (PFS)

Trial Safety

Safety Estimate

1 of 3

Trial Design

8 Treatment Groups

No Control Group
B2

This trial requires 212 total participants across 8 different treatment groups

This trial involves 8 different treatments. Durvalumab is the primary treatment being studied. Participants will be divided into 8 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.

B2Durvalumab + Investigator's choice of chemotherapy + danvatirsen
A1
Drug
Durvalumab
A4
Drug
MEDI5752
A2Durvalumab + danvatirsen
B1Durvalumab + Investigator's choice of chemotherapy
A3Durvalumab + oleclumab
B4
Drug
MEDI5752
B3Durvalumab + investigator's choice of chemotherapy + oleclumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Danvatirsen
Not yet FDA approved
Oleclumab
Not yet FDA approved
Cisplatin
FDA approved
Paclitaxel
FDA approved
Pemetrexed
FDA approved
Durvalumab
FDA approved
Gemcitabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: tumor assessments occur every 6-8 weeks until week 48-52 based on treatment arm & then every 12 weeks until progression, death, withdrawal or study completion up to 24 months. further pfs data will be collected until 6 months post-last patient dosed
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly tumor assessments occur every 6-8 weeks until week 48-52 based on treatment arm & then every 12 weeks until progression, death, withdrawal or study completion up to 24 months. further pfs data will be collected until 6 months post-last patient dosed for reporting.

Closest Location

Research Site - Iowa City, IA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
was given The patient had no previous chemotherapy or any other systemic therapy for metastatic NSCLC. show original
People who had platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease at some point in the past and whose disease has progressed more than 12 months since the end of their last therapy are eligible for this study. show original
Cancer that has spread throughout the body to other organs and can no longer be cured with surgery or radiation therapy. show original
Known tumor PD-L1 status
This text is about the WHO/ECOG status at 0 or 1 at enrollment show original
This means that the animal will live for at least 12 weeks. show original
This means that the troponin level in the blood is below the institutional threshold. 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.

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

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Carcinoma in situ (CIS) accounted for the majority of cases of lung cancer among both males and females. The lowest mortality occurred among males and the highest mortality occurred among females in all age groups.

Unverified Answer

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

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There is no common treatment for non-small-cell lung cancer and many therapies are in use. Because of this, the choice of therapy is usually based on the size of the tumor/nodes, the patient's general health, and the general experience of the physicians.

Unverified Answer

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

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Symptoms and signs for carcinoma, non-small-cell lung are fairly uncommon. A history of chest pain is very specific for carcinoma, non-small-cell lung. The history of a single breath of air is sufficient to make the diagnosis in most patients.

Unverified Answer

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

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In this analysis, 4 of 5 survivors had detectable tumor cells in bone marrow, pleural effusions, or serum following a median follow-up of 1-year and 3-years. None of the 5 patients who had tumor-infiltrating macrophages died due to tumor.

Unverified Answer

What is carcinoma, non-small-cell lung?

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A significant number of patients presenting with lung cancer present with a history of COPD, particularly prior to the initial diagnosis of lung cancer or to referral by a physician to Lung Function Unit. This finding may have significance for appropriate clinical care and referral of such patients to high dependency units and to lung cancer trials.

Unverified Answer

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

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Survival was increased in patients with the earliest carcinoma, NSS carcinoma of the large cell type. A 5% increase in the percentage of carcinoma, NSS at the early stage was associated with a 16% improvement in survival. Survival rates were lowest for patients with late carcinoma, NSS of squamous type.

Unverified Answer

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

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Among individuals with high-grade dysplasia, a high proportion develop carcinoma--mostly in the first 5 years after diagnosis. Findings from a recent study were similar to those in the general population. The occurrence of carcinoma was not associated with the presence of bronchiectasis.

Unverified Answer

What are the latest developments in durvalumab for therapeutic use?

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In this report the promising data of a very recent phase II study with regard to the immunoadditive mechanism of action of durvalumab were highlighted. More studies are needed to understand the mechanism of action of this antibody if we want to achieve more efficient results.

Unverified Answer

Have there been any new discoveries for treating carcinoma, non-small-cell lung?

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Lung cancer has a very poor prognosis, and cancer treatments are in a steady state of development. However, a variety of therapeutic treatments have been introduced and more therapies with more efficient mechanisms are being assessed.

Unverified Answer

What is durvalumab?

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Durvalumab is indicated for patients with symptomatic or progression-free NSCLC who have PD-L1 expression in tumor samples.Durvalumab, has been approved in the EU and the USA. In North America, Durvalumab will most likely be available under the new Breakthrough and Moncrief indications.Durvalumab should be considered to patients with inoperable metastatic NSCLC who have PD-L1 expression in tumor samples.

Unverified Answer

How serious can carcinoma, non-small-cell lung be?

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The mortality rate of patients is higher than anticipated. To reduce this mortality rate, more urgent and thorough investigation is needed to select the high risk patients so that adequate treatment can be given and timely referral for a lung cancer team and the best surgical technique for these patients.

Unverified Answer
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