Stereotactic radiation therapy for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
University of Texas Southwestern Medical Center, Dallas, TX
Carcinoma, Non-Small-Cell Lung+2 More
Stereotactic radiation therapy - Radiation
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

This study is evaluating whether a combination of stereotactic radiotherapy and durvalumab might improve quality of life and oncologic outcomes in patients with advanced non-small cell lung cancer.

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Eligible Conditions

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

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Stereotactic radiation therapy will improve 2 primary outcomes and 7 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of 12 weeks from randomization.

1 year post-treatment
Local control (LC)
Out-of-field control
12 weeks from randomization
overall response rate (ORR)
2 years post-treatment
Instances of Toxicity
Overall Survival
Progression free survival (PFS)
Quality of Life Scores
3 years
Progression free survival
improved Quality of life

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Stereotactic Ablative Radiotherapy (SAbR) Arm plus Durvalumab arm
Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) plus Durvalumab arm

This trial requires 52 total participants across 2 different treatment groups

This trial involves 2 different treatments. Stereotactic Radiation Therapy 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.

Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) plus Durvalumab armPULSAR with each radiation treatment fraction delivered every 4 weeks
Stereotactic Ablative Radiotherapy (SAbR) Arm plus Durvalumab armSAbR with each radiation treatment fraction delivered every other day
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
Stereotactic radiation therapy
Completed Phase 3

Trial Logistics

Trial Timeline

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

Who is running the study

Principal Investigator
D. T. V.
Prof. Dat T. Vo,, MD PhD
University of Texas Southwestern Medical Center

Closest Location

University of Texas Southwestern Medical Center - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Carcinoma, Non-Small-Cell Lung or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have biopsy-proven metastatic non-small cell lung cancer and are eligible for immunotherapy. show original
Patients must have at least one (1) symptomatic or progressive metastatic sites with no more than 10 metastatic sites, based on standard imaging studies
You have received radiation therapy to the intended radiation treatment area. show original
You have metastases in major lower extremity weight-bearing bones or spine and you should undergo surgical stabilization if indicated. show original
Both men and women and members of all races and ethnic groups will be included. show original
You have a performance status of 0 to 2 (Appendix A). show original
Haemoglobin ≥9.0 g/dL
You have either de novo metastatic disease or recurrent disease. show original
Patients with brain metastases may be enrolled if all lesions are treated with radiation therapy or surgery prior to start of protocol therapy. show original
You are not eligible for this study if you are under 18 years of age. 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 are common treatments for carcinoma, non-small-cell lung?

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Non-small-cell lung cancer is most commonly treated with surgery and sometimes chemotherapy. For patients with early-stage tumors, surgery alone or surgery with radiotherapy is the most common treatment method. For nonsquamous cell carcinomas, surgical resection, sometimes combined with chemotherapy and/or radiotherapy, is the most common treatment. For people with squamous cell carcinoma, lung cancer is typically treated with surgery, chemotherapy, and/or radiotherapy.

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What is carcinoma, non-small-cell lung?

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Carcinoma, non-small-cell lung is a deadly disease that has become an epidemic in the industrialized world, affecting mostly non-smokers who never smoked or are light smokers, including those who are current and former military personnel and laborers. The treatment is mainly surgery and radiation.

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

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The data suggest that patients with lung cancer who have not received chemotherapy have a survival rate comparable to other cohorts of patients with advanced lung cancer who have been treated with chemotherapy.

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

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About 12,000 new cases of non-small-cell [lung cancer]( will be diagnosed in the United States in 2012. These cases represent 4% of all cancer diagnoses in the United States.

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What causes carcinoma, non-small-cell lung?

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Smoking and asbestos are known risk factors for lung cancer. Smoking and/or asbestos exposure can affect lung function, resulting in increased risk of developing lung cancer in the later stages of life. Smoking and asbestos-related lung cancer show a different pattern of risk depending on whether the exposure took place before or after age 60 years. Lung function may be compromised, leading to increased risk of lung cancer by mechanisms that are different for younger and older subjects.

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

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Most signs of cancer/carcinoma of the lung are vague, non-specific and unspecific. The most common sign is coughing. Other signs may include wheezing, increased pain, weight loss and fever.

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What are the common side effects of stereotactic radiation therapy?

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Stereotactic therapy can have devastating neurological effects in the absence of a primary tumor mass, which, in turn, can lead to severe neurocognitive deficits. However, we contend that the incidence, severity, and long-term impact of these deficits will be significantly diminished, when appropriately managed, when these patients are enrolled in clinical trials.

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

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There are several [methods of treating malignant lesions in the lung] that require a certain extent of excision before [medication by a radiotherapist]. However, we do not yet know [how quickly malignant lesions in the lung] will spread.

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

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It is important to take into account that the majority of the research on anticancer peptides was conducted using only mice because the mice are a highly valuable small animal model that is highly sensitive, fast-developing, and inexpensive to grow and store. This is especially important in the case of anticancer vaccines, since vaccine treatment requires an adequate immune response to be effective. Currently most anticancer vaccine studies have only focused on treatment strategies involving vaccination using monoclonal antibodies to block PD1 molecules on the cancer cell surface. There are many other therapeutic approaches that are not being explored thoroughly in any vaccine therapy.

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Have there been other clinical trials involving stereotactic radiation therapy?

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Although stereotactic radiation therapy is a novel form of radiation therapy, only a single patient was involved in the study. Furthermore, only 1 patient received both stereotactic therapy and chemotherapy to induce tumor shrinkage. A larger clinical trial is warranted, to investigate the efficacy and safety of stereotactic radiation therapy as a monotherapeutic or as a synergistic therapy in locally advanced, small-bore primary lung cancer patients, at least on an investigator-initiated basis.

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

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Overall survival rates for patients diagnosed with invasive squamous cell carcinoma were more than three times higher than for patients diagnosed with other nonsmall-cell carcinoma histotypes. This difference cannot be explained by stage.

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What are the latest developments in stereotactic radiation therapy for therapeutic use?

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This section focuses on a few new aspects of SRT with regard to its possible use as an adjuvant therapy in patients with newly diagnosed or locally recurrent lung cancer.

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