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Zipalertinib for Non-Small Cell Lung Cancer (REZILIENT1 Trial)
REZILIENT1 Trial Summary
This trial is testing a new drug for patients with a specific type of lung cancer. The goal is to find the best dose of the drug and to see if it is effective.
REZILIENT1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:REZILIENT1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.REZILIENT1 Trial Design
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Who is running the clinical trial?
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- I was hospitalized for lung problems due to COVID-19.I haven't taken EGFR inhibitors for at least 8 days before starting the study drug.I have a history of lung conditions not related to infections.My cancer has a specific EGFR mutation confirmed by a certified test.I have been treated with a drug approved for EGFR ex20ins mutant NSCLC.I have previously been treated with CLN-081.I don't have severe side effects from past cancer treatments, except for hair loss or skin color changes.I have no GI issues or history of major stomach surgery.I have not been treated with poziotinib, mobocertinib, amivantamab, DZD9008, or BDTX-189.I haven't had cancer treatment, except for EGFR-TKIs, in the last 14 days.I have advanced or metastatic non-small cell lung cancer.I haven't had any cancer other than skin or cervical cancer in the last 2 years.I have been treated with a drug targeting EGFR mutations before.I have received treatment for cancer that came back or spread.My brain or spinal metastases are stable and haven't required more medication for 4 weeks.I had COVID-19 or lung issues from it within the last 4 weeks.My cancer has an EGFR ex20ins mutation.I have severe heart failure or serious heart rhythm problems.My lung cancer is advanced or has spread, confirmed by tests.I have not received any treatment for my condition before joining Module A.I can do light work throughout the day.I frequently experience diarrhea, nausea, or vomiting.
- Group 1: Module C
- Group 2: Module B
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 28 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 24 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people have been treated with Zipalertinib before me?
"To date over 200 people have been treated with Zipalertinib"
How safe is Zipalertinib alone or in combination with chemotherapy?
"The study drug is zipalertinib alone, not combined with chemotherapy. The safety profile is favorable and manageable comparing with other treatments and for details"
Will I know what medication I'm taking?
"Yes, all patients in the trial are treated with Zipalterinib"
Can participants with other forms of cancer participate in this trial?
"No"
Will I have access to the study drug or treatment after the trial ends?
"No"
Can I leave this clinical trial if I change my mind or experience side effects?
"Yes, participation in the study is voluntary and you may leave the trial at any time if you decided to"
Can I participate in this clinical trial while receiving other treatments?
"No other anti-tumor treatment allowed."
How long will I be required to participate in this clinical trial?
"Participation in the study will continue until you choose to stop or until your disease worsens, you have a requirement for another anticancer treatment, it is not in your best interest to continue or you have an adverse event which is unmanageable."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- City of Hope Comprehensive Cancer Center: < 24 hours
- University of Michigan Health System - University Hospital: < 24 hours
- NYU Cancer Institute: < 24 hours
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