Consolidative Durvalumab for Stage III Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, TX
Stage III Lung Cancer+3 More
Consolidative Durvalumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help improve survival for individuals with lung cancer.

See full description

Eligible Conditions

  • Stage III Lung Cancer
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Stage III Lung Cancer

Study Objectives

This trial is evaluating whether Consolidative Durvalumab will improve 1 primary outcome and 2 secondary outcomes in patients with Stage III Lung Cancer. Measurement will happen over the course of Twelve months from the study enrollment.

Month 100
Distant metastases free survival
Month 100
Local and regional control
Twelve months from the study enrollment
Progression-free survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Stage III Lung Cancer

Trial Design

1 Treatment Group

Single Arm: Therapeutic Intervention
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. Consolidative 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.

Single Arm: Therapeutic Intervention

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of study enrollment until the date of first documented new distant lesion or date of death from any cause, whichever came first, assessed up to 100 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from date of study enrollment until the date of first documented new distant lesion or date of death from any cause, whichever came first, assessed up to 100 months for reporting.

Who is running the study

Principal Investigator
Y. Z.
Yuanyuan Zhang, MD
University of Texas Southwestern Medical Center

Closest Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas - Dallas, TX

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:
1.1 Pathologically (histologically or cytologically) proven diagnosis of NSCLC with, medically inoperable (or patients who refuse resection) stage IIIA or stage IIIB disease (AJCC 8th edition);
1.1.1 Inoperable Stage IIIA disease is defined by multiple and/or bulky N2 mediastinal lymph nodes on computed tomography (CT) scan such that, in the opinion of the treating investigator, the patient was not a candidate for surgical resection.
1.1.2 N2 disease must have been documented by biopsy, or at a minimum by fluorodeoxyglucose positron emission tomography (PET) or CT if nodes were more than 2 cm in short axis diameter.
1.1.3 T4 disease is often considered resectable at the discretion of a thoracic surgeon. Patients with T4N0 or T4N1 disease can be enrolled if their case is reviewed by a thoracic surgeon and felt to be unresectable or if they are either medically inoperable or refuse surgery.
1.1.4 Stage IIIB patients have N3 or T4N2 status. N3 status must have been documented by the presence of a contralateral (to the primary tumor) mediastinal lymph node or supraclavicular or scalene lymph node proven by biopsy, or at a minimum by fluorodeoxyglucose uptake on PET or more than 2 cm in short axis diameter on CT scan. Patients with disease extending into the cervical region (defined as disease extending above cricoid cartilage) are not eligible.
1.2.1 History/physical examination, including documentation of height, weight and vital signs, within 30 days prior to registration;
1.2.2 CT scan with IV contrast (CT scan without contrast acceptable if IV contrast is medically contraindicated) of the lung and upper abdomen through the adrenal glands within 60 days prior to registration (recommended within 30 days prior to registration);
1.2.3 MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 60 days prior to registration; note: the use of intravenous contrast is required for the MRI or CT (unless medically contra-indicated).
1.2.4 Whole-body FDG-PET/CT within 60 days prior to registration;
1.3 Age ≥ 18 years;

Patient Q&A Section

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

"Around 80,000 people are diagnosed with NSCLC a year in the United States, making [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) the most common form of cancer in American women." - Anonymous Online Contributor

Unverified Answer

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

"Lung cancer is typically diagnosed at an advanced stage because of its typical nonspecific signs. Early detection has made it possible to cure a significant number of patients, who would otherwise have not received any potentially curative treatment. Most patients with stage I NSCLC can be cured. Most patients with stage II disease should be considered curable. Patients with stage III, localized disease, or high-grade histology have a low cure rate that is only marginally increased if the patient is treated with chemotherapy and/or radiation. Patients with metastatic disease have a survival considerably shorter than patients with localized disease. Only patients with a large tumor are curable in the vast majority of cases." - Anonymous Online Contributor

Unverified Answer

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

"Several treatments are used in the treatment of NSCLC and their use is based on many factors including the stage, metastatic disease, and comorbid diseases. The treatments used for NSCLC include surgery, chemotherapy-based regimes, radiation therapy, immunotherapy, targeted therapies and combinations." - Anonymous Online Contributor

Unverified Answer

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

"Symptoms vary from asymptomatic to acute and severe. The commonest symptoms were fever, malaise, weight loss and dyspnea. Symptoms were more frequently related to pleural or hilar involvement and were more common in stage III and IV disease. Symptoms were less common in stage IA. Symptoms were not specific for malignancy." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, non-small-cell lung?

"Cancer of the lung is attributable to cigarette smoking, other risk factors including environmental tobacco smoke, and genetic susceptibility in some cases. The increased cancer risk with passive smoking has been documented in the UK and USA, and in studies in several other European countries. Cigarette smoking is the primary cause of lung cancer. Smoking must be avoided in order to reduce cancer risk." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, non-small-cell lung?

"Carcinoma, non-small-cell lung is a clinical diagnosis and not a pathological diagnosis. Unlike in small-cell lung cancer, lymph node examination is generally not performed. We are currently considering the need to revisit the current guidelines for carcinoma, non-small-cell lung, as a more complete pathology report may help to identify tumors that are less likely to respond to treatment." - Anonymous Online Contributor

Unverified Answer

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

"Recent findings from multiple studies indicate that lung carcinoma spreads very quickly outside the bounds of the lung in the pleural space and in the pericardium or mediastinum. On the basis of this data, we advocate removal of the lung in all cases of carcinoma, regardless of any metastases already found." - Anonymous Online Contributor

Unverified Answer

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

"Most metastatic patients were treated with chemotherapy. The survival rate is comparable with other trials in stage IIIa-IIIb, including some of the most active chemotherapy regimens, which have been already tested in adjuvant settings. However, patients who are untreated have a better survival rate than patients who are treated and show a relevant improvement in survival, especially with chemotherapy plus thoracic radiotherapy. The improvement is not as large as obtained in some other trials, but should be discussed cautiously. The benefit of surgery of the lymph nodes has to be proven. Further randomized controlled trials, especially tailored and conducted with more advanced treatments in combination with the already known standard regimens should also be considered, especially when the survival rate drops significantly." - Anonymous Online Contributor

Unverified Answer

Has consolidative durvalumab proven to be more effective than a placebo?

"Although durable response rates were not significantly improved, a trend towards better overall survival was noted. The benefit in OS was particularly obvious in patients under 75 years of age, but the effect was not statistically signifiant compared to other studies in patients of the same age group." - Anonymous Online Contributor

Unverified Answer

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

"The survival rate in this study was only 5.7% with a median survival of 7.5 months, lower than that reported in the literature. Survival rates are also lower at presentation and in the late stages of the disease. The survival rate for Stage III-IV is the lowest at 9.7% with a mean survival of 6.2 months." - Anonymous Online Contributor

Unverified Answer

How does consolidative durvalumab work?

"This phase 1 trial demonstrates durable results with durvalumab, especially in patients with HER2-positive/metschnikow tumor histology. Further studies are required to determine whether the combination of durvalumab and other drugs can prevent progression and prolong survival when used as a neoadjuvant." - Anonymous Online Contributor

Unverified Answer

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

"A significant fraction of NSCLC patients (≤ 30%) have a history of cancer within their families. These patients may benefit from genetic counselling and risk analysis during their pre-treatment evaluation. However, this information may not be useful for the selection of adjuvant treatment and decision to use neoadjuvant chemotherapy." - Anonymous Online Contributor

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