CLINICAL TRIAL

Osimertinib for Lung Cancer

Recruiting · 18+ · All Sexes · Harrison, NY

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

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About the trial for Lung Cancer

Eligible Conditions
Metastatic Non-small Cell Lung Cancer · Lung Neoplasms

Treatment Groups

This trial involves 2 different treatments. Osimertinib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Osimertinib
DRUG
Experimental Group 2
Osimertinib
DRUG
+
Carboplatin
DRUG
+
Pemetrexed
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved
Carboplatin
FDA approved
Pemetrexed
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:
The patient may have started osimertinib within 3 weeks of confirming eligibility and enrollment criteria of measurable disease per approval of PI, with no prior chemotherapy for treatment of metastatic disease (adjuvant therapy > 6 months prior to study start is acceptable). show original
The text is about a patient who is starting osimertinib treatment and investigators will measure the patient's tumor to see if it has changed since before treatment. show original
Age ≥ 18 years
Someone who needs a transplant may not be a good candidate if they have adequate organ function. 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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
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 Osimertinib will improve 1 primary outcome and 1 secondary outcome in patients with Lung Cancer. Measurement will happen over the course of 2 years.

overall response rate
2 YEARS
Best overall response rate (confirmed partial and complete responses) will be assessed as part of this study. All responses must be confirmed on subsequent scan to be considered a true response. Tumor response will be assessed using RECIST 1.1. For patients enrolled in the randomized treatment portion of study. Confirmation of baseline measurable disease for all patients will be determined via investigator review.
Determine the progression-free survival
2 YEARS
As the primary endpoint for the treatment comparison, it is the duration of time from randomization to the time of disease progression (in the CNS or systemically) or death. In addition, as a secondary endpoint, PFS is measured from the start of treatment to disease progression or death. Intracranial progression-free survival (PFS) is defined as the duration of time from time of randomization to time of progression (in the CNS) or death, whichever occurs first. Overall survival (OS) is defined as the duration of time from first treatment to time of death.

Patient Q & A Section

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

How does osimertinib work?

When comparing osimertinib with chemotherapy alone, patients treated with osimertinib had a significantly higher response rate, longer progression-free and survival for patients with advanced NSCLC, and osimertinib treatment for 3 months prior to chemotherapy should be strongly recommended as standard first-line treatment for this disease.

Anonymous Patient Answer

Has osimertinib proven to be more effective than a placebo?

Taken together, these results suggest that OSI-190 deserves further investigation. A study with a larger number of smokers would be needed to confirm the effects of OSI-190 on cancer prevention.

Anonymous Patient Answer

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

Every year, the risk of getting [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) increases by 0.27% for men and 0.20% for women. The most common methods for detecting the disease are smoking cessation at a hospital and regular chest X-rays. The 5 leading causes of cancer deaths are lung, colon, stomach, liver, and larynx cancer. The 5 leading causes of death from cancer are lung cancer, pancreatic cancer, prostate cancer, breast cancer, and colorectal cancer.

Anonymous Patient Answer

What causes lung cancer?

At a basic level, lung cancer occurs because cells in the lungs have problematic changes (mutation) to their DNA. On a more complex level, smoking, air pollution, and genetics modify these changes and they combine to cause a risk of developing lung cancer of about 20% by age 75.

Anonymous Patient Answer

Can lung cancer be cured?

The 5 yr survival for SCLC is 20.4%, while non-small cell lung cancers with adenocarcinoma (n = 923) or squamous cell carcinoma (n = 563) combined showed a 5 yr survival of 10.6%. In the current times and with modern treatment the survival rates for all the forms of lung cancer can be improved with a treatment algorithm similar to that shown in earlier time periods.

Anonymous Patient Answer

What is lung cancer?

Lung cancer is the cancer that kills the most people per year in the United States. It often begins subtly in the form of a non-specific cough that does not get worse and that is not associated with significant weight loss. It rarely can be identified in women except at an advanced stage, and is therefore a disease that is often diagnosed much later.

Anonymous Patient Answer

What are the signs of lung cancer?

As well as signs of fatigue, joint pain or loss of appetite being present, the signs of lung cancer may include a nonproductive cough, shortness of breath, weight loss and unexplained bleeding.

Anonymous Patient Answer

What are common treatments for lung cancer?

Common treatment options for [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) include surgery, chemotherapy, radiation therapy, targeted therapy, or a combination of these. Surgery is the first-line treatment for early stage (I and II) nonsmall cell cancer. If the lung cancer metastasizes (IIIA and IIIB), then systemic therapy is often preferred rather than surgery.

Anonymous Patient Answer

Does lung cancer run in families?

The familial clustering of lung cancer in the study population suggests a hereditary component in lung cancer-like susceptibility. However, the familial clustering did not seem to be independent from environmental and occupational factors. The major conclusions in this study are that familial clustering of lung cancer could be an indication of a genetic susceptibility to lung cancer, but not a proof of disease inheritance.

Anonymous Patient Answer

What are the chances of developing lung cancer?

While many factors contribute to lung cancer's ability to development we found one thing in common: a genetic predisposition. In the US: 1 in 16 Caucasians (around 6,000,000 people in 2008) were estimated to carry at least one mutated gene linked to lung cancer development. In 2008, the annual lung cancer mortality rate in men was 2.3 per 100,000 and 0.3 per 100,000 in women. Rates for non-smoker and non-Hispanic men/women: 2.6 and 3.7 per 100,000 respectively.

Anonymous Patient Answer

Is osimertinib safe for people?

Osimertinib is generally well tolerated in patients over 70 years with NSCLC. There is limited evidence for safety during pregnancy and it will be important to monitor for any changes in liver, kidney and thyroid function.

Anonymous Patient Answer

Have there been other clinical trials involving osimertinib?

Osimertinib is well tolerated and active against ALK inhibitors resistant tumors. Osimertinib has also activity against tumors with EGFR mutations. A phase 3 trial of osimertinib in patients with stage III/IV NSCLC and T790M mutant EML4-ALK is ongoing. In this trial, patients will have a high rate of progression after two years of treatment.

Anonymous Patient Answer
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