Quality-of-Life Assessment for Lung Cancer

1
Effectiveness
1
Safety
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, CA
Lung Cancer+11 More
Quality-of-Life Assessment - Other
Eligibility
18+
All Sexes
Eligible conditions
Lung Cancer

Study Summary

This study is evaluating whether a combination of temozolomide, niraparib, and atezolizumab is safe and effective in treating patients with advanced solid tumors and extensive-stage small cell lung cancer.

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Eligible Conditions

  • Lung Cancer
  • Lung Neoplasms
  • Carcinoma, Small Cell
  • Small Cell Lung Carcinoma
  • Stage IIIA Lung Cancer AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Extensive Stage Small Cell Lung Carcinoma
  • Advanced Malignant Solid Neoplasm
  • Stage IV Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Quality-of-Life Assessment will improve 2 primary outcomes, 3 secondary outcomes, and 1 other outcome in patients with Lung Cancer. Measurement will happen over the course of At 28 days.

At 28 days
Recommended phase II dose of niraparib and temozolomide combination (Phase Ib)
Month 36
Progression-free survival (Phase II)
Month 36
Overall survival
Up to 36 months
Incidence of adverse events per Common Terminology Criteria for Adverse Events version 4.0
Objective response rate
Quality of life per Functional Assessment of Cancer Therapy - Lung questionnaire (FACT-L)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Arm B (atezolizumab)
Arm A (temozolomide, niraparib, atezolizumab)

This trial requires 74 total participants across 2 different treatment groups

This trial involves 2 different treatments. Quality-of-Life Assessment 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 1 & 2 and have already been tested with other people.

Arm A (temozolomide, niraparib, atezolizumab)Patients receive temozolomide PO QD on days 1-5 and niraparib PO QD on days 1-28. Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care atezolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.
Arm B (atezolizumab)Patients receive standard of care atezolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
FDA approved
Temozolomide
FDA approved
Atezolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 36 months for reporting.

Closest Location

UCLA / Jonsson Comprehensive Cancer Center - Los Angeles, CA

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:
Willing and able to provide informed consent.
Cytologically or histologically confirmed advanced and incurable solid malignancy.
For the Phase 1b, Part 2 cohort, participants must have a tumor type for which atezolizumab is an Food and Drug Administration (FDA) approved therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of =< 1.
Able to swallow the study drugs, has no known intolerance of study drugs or excipients, and able to comply with study requirements.
Absolute neutrophil count (ANC) >= 1,500 /mcL.
Platelets >= 100,000 / mcL.
Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 4 weeks of first dose).
Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance >= 30 mL/min for participants with creatinine levels > 1.5 X institutional ULN. (Glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]).
Creatinine clearance should be calculated using the standard Cockcroft and Gault equation.

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 lung cancer?

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There are many treatment options for lung cancer patients. If the disease is managed by specialists like surgeons or radiation oncologists, treatment options are minimized and individualized with respect to age, disease stage, and patient health. If the disease is managed by general oncologists, clinicians must be vigilant about which medications can be used to optimize disease control, maximize symptom relief but minimize side effects.

Unverified Answer

How many people get lung cancer a year in the United States?

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Approximately 1 in 6 American adults are diagnosed with lung cancer each year. In California, it is estimated that 1 in 5 young adults and 1 in 7 middle-aged and elderly adults are diagnosed with lung cancer.

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What causes lung cancer?

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This article examines risk factors for cancer of the respiratory tract and for lung cancer in general. Several well-known factors have a significant role in the development or progression of lung cancer including smoking, radon exposure, asbestos, exposure to pesticides, family history, and other inherited or acquired genetic factors. In this article, the most important risk factors are asbestos exposure and tobacco use.

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Can lung cancer be cured?

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Although the most effective form of treatment for lung cancer remains surgery, with adjuvant radiotherapy, and with a 5-year survival rate approaching 50%, the prognosis is not favorable with a poorer prognosis and higher likelihood of dying before 5 years when lung cancer does metastasize.

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What are the signs of lung cancer?

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The only significant early symptom of lung cancer is chest pain. Patients complain of coughing and shortness of breath, though they may also have weight loss, fever and night sweats. Persistent, chronic cough can only be explained by an underlying lung mass. Patients with loss of appetite but an otherwise unremarkable x ray are most likely to have either a brain tumour or metastasis.

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What is lung cancer?

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Lung cancer is one of the leading causes of death in the US. It is a disease with several different types and is diagnosed with radiographic screenings such as computed tomography scans and chest X-rays. The cancer is staged, and if the cancer is found early, it can be treated with effective treatment. More research is needed on the causes and treatments of lung cancer.

Unverified Answer

What is quality-of-life assessment?

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To quantify quality of life in lung cancer patients, we have adapted the European Organization for the Study of Quality of Life questionnaire. Such an adaptation would be worthwhile also because we have demonstrated the close relationship between subjective health and other health variables. This type of questionnaire also allows us to use it in clinical trials because a similar instrument has already been used for some years

Unverified Answer

Has quality-of-life assessment proven to be more effective than a placebo?

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A statistically significant advantage in QoL and QoL of life was found when GCSI patients were treated compared to patients who received a placebo. Further studies are needed to investigate whether this difference can be translated into a larger clinical study with QoL measurement as one of the main objectives.

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Have there been other clinical trials involving quality-of-life assessment?

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This initial study has shown that the DFSQ has the potential to be the next clinical tool to supplement QOL measures, e.g. performance status, used to measure the patients' global functional status.

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How does quality-of-life assessment work?

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A more general QOL assessment could lead to new discoveries of information on the natural course of cancer survivors' QOL. The question about the role of QOL has been the most frequently asked question. Quality-of-life research in the field of oncology has been mainly concerned with QOL assessment.

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Have there been any new discoveries for treating lung cancer?

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There have been some new discoveries for treating [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer). The first part of that is to discover what causes lung cancer in the first place? The second part is to find the best way to detect lung cancer earlier using the lowest number of tests so that more people can be treated. The third part is to treat the cancer.
For more information please visit us at Blk Super Specialties Hospital Delhi

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Does lung cancer run in families?

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To date, a majority of the existing epidemiological data is limited to small populations in Europe and North America. Findings from a recent study represents the largest investigation to date of all lung cancers in a genetically homogenous, well-characterized, and racially diverse population.

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