CLINICAL TRIAL

durvalumab for Carcinoma, Non-Small-Cell Lung

Metastatic
Stage III
Waitlist Available · 18+ · All Sexes · Dallas, TX

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

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About the trial for Carcinoma, Non-Small-Cell Lung

Eligible Conditions
Non-Small Cell Lung Cancer NSCLC · Carcinoma, Non-Small-Cell Lung · Lung Neoplasms

Treatment Groups

This trial involves 2 different treatments. Durvalumab 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 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
durvalumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People receiving this treatment must not have received any other therapy for stage IV NSCLC. show original
The patients must have a disease that can be measured. show original
The life expectancy of a human fetus is greater than 12 weeks. show original
ECOG performance status of 2.
Written informed consent
Patients with non-small cell lung cancer that is Stage IIIB or IV (American Joint Committee on Cancer, 7th edition; AJCC 7) must have histologically or cytologically confirmed cancer. show original
We have tissue available for the PD-L1 assay, whether it is from an archived tumor biopsy or a fresh one. show original
The absolute neutrophil count is equal to or greater than 1500 per cubic millimeter. show original
Hemoglobin ≥ 9.0 g/dL
You must be at least 18 years old to participate in this study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 42 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 42 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 42 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether durvalumab will improve 2 primary outcomes and 3 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of At baseline, the end of each treatment cycle, and at the end of therapy; Up to 30 months.

Health Related Quality of Life (HRQL) - FACT-L questionnaire
AT BASELINE, THE END OF EACH TREATMENT CYCLE, AND AT THE END OF THERAPY; UP TO 30 MONTHS
Patient self-administered questionnaire that measures the respondents' health state over the last 7 days.Scoring: Five-point scale: 0 (not at all) to 4 (very much) Note: Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.
AT BASELINE, THE END OF EACH TREATMENT CYCLE, AND AT THE END OF THERAPY; UP TO 30 MONTHS
Treatment-related Adverse Events
UP TO 33 MONTHS
Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 that are possibly, probably or definitely related to study treatment.
UP TO 33 MONTHS
Overall Survival
UP TO 42 MONTHS
Median length of time from the start of treatment that patients are still alive.
UP TO 42 MONTHS
Progression-Free Survival (PFS)
UP TO 42 MONTHS
The duration of time from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.0 Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions:Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
UP TO 42 MONTHS
Overall Response Rate (ORR)
UP TO 42 MONTHS
Proportion of patients who achieve either a Complete Response or Partial Response to study treatment. Per RECIST v1.0, for target lesions: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. For non-target lesions: Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). If tumor markers are initially above the upper normal limit, they must normalize for a patient to be considered in complete clinical response. Non-CR/Non-PD: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
UP TO 42 MONTHS

Who is running the study

Principal Investigator
L. V.
Prof. Liza Villaruz, Assistant Professor of Medicine, Division of Hematology Oncology
University of Pittsburgh

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

Nodules are a very early sign of malignancy in the lung and other major organs of the lung including the brain. Other late-stage signs of lung cancer may include weight loss, fatigue, chest pain, shortness of breath.

Anonymous Patient Answer

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

Currently, there is an unmet demand for lung cancer treatments. Lung cancer should be regarded as treatable, and all patients should be offered potential lung cancer treatments, and, preferably, have a high level of care and supportive support at the end of life.

Anonymous Patient Answer

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

Among all forms of cancer, lung cancer is the most common cause of cancer death in the United States by absolute number of cases (8,842) and per capita (1.5) incidence (3%).

Anonymous Patient Answer

What causes carcinoma, non-small-cell lung?

Non-cancer causes of death are important and need further study. The major causal factors are smoking, a host of other medical factors, and exposures from the ambient environment. The contributions of tobacco and other external environmental causes of lung cancer mortality are less well understood. Tobacco use is the primary single determinant of lung cancer mortality in the US population, and the lung cancer mortality rate is steadily increasing with declining cigarette use.

Anonymous Patient Answer

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

Cetuximab can augment the effects of radiotherapy in non-small-cell lung cancer in certain situations, such as p53 mutation and EGFR mutation. Surgical resection is recommended in certain subtypes. Adjuvant therapy with a tyrosine kinase inhibitor may improve the efficiency of chemotherapy. Chemotherapy with chemotherapy plus a tyrosine kinase inhibitor is a potentially highly active regimen in non-small-cell lung cancer.

Anonymous Patient Answer

What is carcinoma, non-small-cell lung?

The epidemiology, clinical features, and radiographic appearance of NSCLC differ widely in different geographic regions. For example, in the United States, adenocarcinoma of the lung accounts for most cases. Tumor types vary with race and gender. Most patients, regardless of age, have distant metastasis. The prognosis of NSCLC may improve with advances in tumor staging.

Anonymous Patient Answer

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

The research findings showed that the gene expressions of AHRH1, CYPI, and HIF1A in carcinoma, non-small-cell lung cell lines were altered at different time point. The altered gene expressions of these three genes may function as a potential diagnostic tool and/or therapeutic target for carcinoma, non-small-cell lung.

Anonymous Patient Answer

What are the latest developments in durvalumab for therapeutic use?

Durvalumab has demonstrated high and durable responses in a subset of patients with nimotuzumab-resistant [metastatic breast cancer](https://www.withpower.com/clinical-trials/metastatic-breast-cancer) at the dose of 300 mg (m.o.), with a similar tolerability profile, thus supporting a role for this antibody in this treatment scenario. In a recent study, findings, as well as further results of the upcoming Phase I/II REVIGATE clinical trial (Durvalumab For Combining With Vemurafenib In Metastatic Breast Cancer - REVIGATE, NCT00584465) suggest the potential for a role for durvalumab in the treatment of breast cancer.

Anonymous Patient Answer

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

Lung carcinoma is an insidious malignancy, usually first detected at a late stage. We believe our results may be an impetus to launch a systematic investigation into lung carcinoma by radiology residents throughout the country.

Anonymous Patient Answer

What is durvalumab?

After more than 1 year of follow-up, survival was markedly prolonged in DURVEYLEX-treated patients with NSCLC. Survival was further improved in patients that received treatment with DURVALUMAB for up to 8 months. In patients treated with DURVALUMAB, the median overall survival rate was 22.5 months, which was higher than the 16-month median survival rate in patients who received other treatments for advanced NSCLC.

Anonymous Patient Answer

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

These data suggest that lung cancer patients with stage IV disease who are medically unfit or have a life expectancy of less than 6 months should be considered candidates for clinical trials.

Anonymous Patient Answer

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

As the world population ages, the number of patients with pulmonary carcinoma increases. Although the prevalence and incidence rates decrease worldwide, the rate of mortality rises because of the late presentation of lung carcinoma; many patients present at an advanced disease stage. Currently, most patients can benefit from surgery, radiation therapy, and chemotherapy. The efficacy of radiosurgery has not been established but seems to provide better local control. Targeted therapy (bevacizumab plus paclitaxel) has not shown evidence of superiority in lung carcinoma treated with radiotherapy. However, it may be a useful adjunct therapy to minimize side effects of radiotherapy.

Anonymous Patient Answer
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