Osimertinib for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
1
Effectiveness
1
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Carcinoma, Non-Small-Cell Lung+5 More
Osimertinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

This study is evaluating whether a new drug called osimertinib and tegavivint can stop the growth of tumor cells in people with non-small cell lung cancer.

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Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Stage IV Lung Cancer AJCC v8
  • Metastatic Lung Non-Small Cell Carcinoma
  • Lung Neoplasms
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Osimertinib will improve 1 primary outcome, 4 secondary outcomes, and 5 other outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Up to 28 days.

Baseline to 4 years
Fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET) imaging
Year 4
Progression free survival
Year 4
Duration of response
Year 4
Overall survival
Day 22
Osimertinib (AZD9291) PK
Day 22
Tegavivint (BC2059) pharmacokinetics (PK)
Up to 28 days
Maximum tolerated dose
Up to 4 years
Circulating tumor deoxyribonucleic acid (ctDNA)
Overall response rate (ORR)
Β-catenin pathway activity

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment (osimertinib, tegavivint)

This trial requires 18 total participants across 2 different treatment groups

This trial involves 2 different treatments. Osimertinib 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 and are in the first stage of evaluation with people.

Treatment (osimertinib, tegavivint)Patients receive osimertinib PO QD on days 1-28 and tegavivint IV on day 1. Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive osimertinib PO QD on days 1-28. Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved
Tegavivint
2018
Completed Phase 1
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 4 years for reporting.

Who is running the study

Principal Investigator
R. M.
Regan Memmott, Principal Investigator
Ohio State University Comprehensive Cancer Center

Closest Location

Ohio State University Comprehensive Cancer Center - Columbus, OH

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:
Age >= 18 years. Children are excluded from this study because neither dosing nor safety data are currently available for AZD9291 or BC2059 in patients < 18 years of age
Pathology-confirmed metastatic NSCLC
A common activating mutation must be present in the EGFR gene, i.e., exon 19 deletion or L858R. The presence of uncommon EGFR mutations, e.g., G719X, S768I, or L861Q are also permitted if they co-occur with a common activating mutation. Mutation status must be determined using a tumor biopsy by local Clinical Laboratory Improvement Act (CLIA)-certified assessment. Mutations identified by blood-based testing can be provided, but must be verified by tumor biopsy
The presence of a concurrent T790M mutation, while uncommon in patients who are naïve to treatment with EGFR TKIs, is also permitted
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
The patient must be able to swallow pills
Life expectancy > 3 months
Leukocytes >= 3,000/mcL
Absolute neutrophil count >= 1,500/mcL

Patient Q&A Section

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

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

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Carcinoma of the lung has high mortality if untreated. Early detection with chest radiographs alone can improve survival. In the advanced stages of the disease, in most patients, most of the cancer must be removed to survive for five years. Treatment options for lung cancer after surgery that may permit survival of 5 years include postoperative radiation therapy, and chemotherapy at low doses with or without surgery. As of this year there is no therapy that can cure advanced cancer.

Unverified Answer

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

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Despite a significant increase in cigarette smoking among men over the past 30 years, only 16.8% of all non-smokers diagnosed with NSCLC died in 2005-2006, compared with 29.7% of all men who died. These data suggest that progress in reducing tobacco use, particularly among men, may be critical to reducing NSCLC mortality but that progress may take time.

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What is carcinoma, non-small-cell lung?

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Cancer, including [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer), is the most common cause of cancer death in the UK although survival rates improved steadily between 1990 and 2011. The most common forms of lung cancer were squamous-cell lung cancer and adenocarcinoma.

Unverified Answer

What causes carcinoma, non-small-cell lung?

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It is recommended to carry out regular follow-up examinations on patients for early detection of the development of complications and recurrence of carcinoma, non-small-cell lung.

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

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Nearly all patients with carcinoma, non-small-cell lung receive some type of definitive treatment. Some treatment options are surgery, biopsy, radiation, chemotherapy, or a combination of these choices. The treatment depends on the tumor's specific characteristics and on the health of the patient.

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

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In this selected group, only a high grade of dysplasia or pleural effusion was associated with cancer. A negative radiograph without lung biopsy showing no evidence of cancer was the most accurate predictor of the presence of cancer.

Unverified Answer

Have there been other clinical trials involving osimertinib?

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Osimertinib showed promising response for MCL patients treated by R-CHOP, in contrast with R-CHOP failure for non-Hodgkin's lymphoma, but also has adverse toxicity for the patients.

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

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The data from the published reviews are encouraging. In a meta-analysis, the results indicate that combining platinum-based chemotherapy with EGFR inhibition increases pCR and survival rate compared with platinum chemo alone.

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

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Given the low penetrance, late diagnosis, and the poor prognosis associated with early-onset lung cancer, the identification of hereditary risk factors such as a single genetic mutation, may play only a small role in the development of lung cancer.

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

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The most important determinant of survival from carcinoma, non-small-cell lung, and this disease is not the clinical stage. The most important predictor of survival is the number of involved lymph nodes, an important determinant of which is the extent of this disease (number of positive nodes + extranodal involvement). The extent of a patient's disease is very important for prognosis. Also, this disease is a serious one for most patients, and as a general rule should be managed with a combination of surgery, radiation, chemotherapy, plus symptomatic and immunological therapy.

Unverified Answer

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

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Many treatments are discussed in the literature but many who take them become too uncomfortable to endure further treatment. Our patients seem to be getting the news they hope for.

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What is the primary cause of carcinoma, non-small-cell lung?

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We conclude that the cause of carcinoma, non-small-cell lung is largely unknown. In our population, gender, cigarette smoking, and a history of other malignancy did not help to explain lung cancer incidence or to identify which individuals would be susceptible to developing lung cancer. In a recent study, findings suggest that lung cancer can be prevented, or partially prevented, by a variety of risk factors that are not clearly identifiable.

Unverified Answer
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