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Trastuzumab Deruxtecan for Non-Small Cell Lung Cancer
Study Summary
This trial will compare the effectiveness and safety of Trastuzumab Deruxtecan to the current standard of care for treating non-small cell lung cancer with HER2 Exon 19 or 20 mutations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have brain metastases, but they are currently treated and not active.My heart, kidneys, and liver are functioning well.I have or might have a lung condition not caused by an infection.I have not received any treatment for my advanced or spread cancer.My tumor has a specific change in genes like EGFR or ALK that can be treated with targeted therapy.I am 18 years old or older.My cancer cannot be cured with surgery or radiation and may have spread.My non-small cell lung cancer has a specific HER2 mutation.I cannot receive platinum-based chemotherapy or pembrolizumab due to health reasons.I have tumor tissue available for testing.I had a heart attack in the last 6 months.Your heart's pumping function is normal.I have a severe lung illness that affects my daily life.I am fully active and can carry on all my pre-disease activities without restriction.Your doctor can measure your disease using a specific set of guidelines called RECIST 1.1.I have an active autoimmune or inflammatory condition.
- Group 1: Arm 2
- Group 2: Arm 1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Can people who are over twenty participate in this research study?
"In order to enroll in this particular clinical trial, patients must be between the ages of 18-123. There are a total of 3942 studies for people over 65 and 169 for those under 18."
Might this study be a good fit for you or someone you know?
"To be eligible for this study, patients must have carcinoma, non-small-cell lung and be aged between 18 and 123. In addition, patients must meet the following criteria: Locally advanced not amenable to curative therapy, or metastatic disease, Measurable disease assessed by Investigator based on RECIST 1.1, ECOG 0-1, Participants at least 18 years of age, Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease."
What is the projected amount of people who will be taking part in this research?
"Yes, this is an active recruitment. According to the information provided on clinicaltrials.gov, the trial was posted on 10/28/2021 and last updated on 11/10/2022. They are looking for 264 subjects from 26 sites in total."
Is this trial widespread throughout the state?
"There are 26 sites running this clinical trial, with locations in Silver Spring, Basking Ridge and Montvale. It is advisable that patients pick the location closest to them to reduce travel burdens if they enroll in the study."
Are there any open positions in this clinical trial for new patients?
"That is accurate. According to the listing on clinicaltrials.gov, this trial is still recruiting patients. This research project was initially posted on October 28th 2021 and last updated November 10th 2022. They are looking for a total of 264 people spread out over 26 locations."
When will Trastuzumab Deruxtecan be available to the public?
"Trastuzumab Deruxtecan was given a safety score of 3. This is because Phase 3 trials have shown some efficacy and there is also multiple rounds of data that supports Trastuzumab Deruxtecan's safety."
Are there any ongoing or previous investigations on Trastuzumab Deruxtecan?
"Trastuzumab Deruxtecan was first studied in 1997. Since then, there have been a total of 1994 clinical trials completed with 2078 currently underway. A large proportion of these live studies are based out of Silver Spring, Maryland."
What disease is Trastuzumab Deruxtecan most commonly used as a treatment for?
"Trastuzumab Deruxtecan is most often used as a treatment for cancer. However, it has also been shown to be effective in treating unresectable melanoma, microsatellite instability high, and locally advanced nonsquamous non-small cell lung cancer."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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