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Tyrosine Kinase Inhibitor
Zipalertinib for Non-Small Cell Lung Cancer (REZILIENT2 Trial)
Phase 2
Recruiting
Research Sponsored by Taiho Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented other non-ex20ins uncommon single or compound EGFRmt status for Cohort D patients
Archival tumor tissue available for submission for Cohort D patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
REZILIENT2 Trial Summary
This trial is testing a new drug to treat lung cancer with EGFR mutations.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that have specific mutations called EGFR exon 20 insertions or other uncommon mutations. Participants must not have had prior systemic therapy for advanced disease, except in certain cohorts where progression after such therapies is required. They should be able to perform daily activities with minimal assistance and agree to use birth control. People with recent COVID-19, significant heart issues, another primary malignancy within the last two years, or who are pregnant can't join.Check my eligibility
What is being tested?
The study tests Zipalertinib's safety and effectiveness on patients with NSCLC harboring specific genetic changes. It involves different patient groups based on their treatment history and mutation type, assessing how well they respond to this new drug and monitoring any improvements in their condition.See study design
What are the potential side effects?
While the side effects of Zipalertinib aren't detailed here, similar drugs often cause fatigue, diarrhea, skin reactions, mouth sores, decreased appetite and potential risks to liver function. Patients may also experience unique side effects due to their individual health conditions.
REZILIENT2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a specific EGFR mutation, not the ex20ins type.
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I can provide samples of my tumor for research.
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I have brain metastases.
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I haven't had systemic therapy for my advanced disease.
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I am fully active or can carry out light work.
Select...
My cancer has a specific EGFR mutation.
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My condition worsened after treatment targeting a specific mutation.
REZILIENT2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All Cohorts: objective response rate (ORR)
Secondary outcome measures
All Cohorts: Disease control rate (DCR)
All Cohorts: Duration of response (DoR)
All Cohorts: Overall Survival (OS)
+6 moreOther outcome measures
EGFR mutation status
Pharmacokinetic (PK) parameter
REZILIENT2 Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort D ("other uncommon EGFRmt").Experimental Treatment1 Intervention
Cohort D participants will receive zipalertinib orally twice a day (BID) continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.
Group II: Cohort C ("active brain mets")Experimental Treatment1 Intervention
Cohort C participants will receive zipalertinib orally twice a day (BID) continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.
Group III: Cohort B ("1st line treatment")Experimental Treatment1 Intervention
Cohort B participants will receive zipalertinib orally twice a day (BID) continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.
Group IV: Cohort A ("prior ex20ins treatment")Experimental Treatment1 Intervention
Cohort A ("prior ex20ins treatment") participants will receive zipalertinib orally twice a day (BID) continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.
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Who is running the clinical trial?
Taiho Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
11,424 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had chest radiation therapy less than 28 days ago or palliative radiation less than 14 days ago.I can provide samples of my tumor for research.I haven't had cancer immunotherapy in the last 28 days.I have taken Zipalertinib (TAS6417/CLN081) before.I am at least 18 years old or considered an adult by my country's laws.I have not had major surgery in the last 4 weeks.I have brain metastases.My organs are working well.Women who could become pregnant must have a negative pregnancy test.I had COVID-19 or its symptoms within the last 4 weeks.I cannot swallow pills or have a condition affecting how my body absorbs medication.I have not had another cancer within the last 2 years.My cancer has a specific EGFR mutation, not the ex20ins type.I have heart problems that affect my daily activities.I agree to use effective birth control during the study.I haven't had systemic therapy for my advanced disease.I am fully active or can carry out light work.Patients in Cohort D must have measurable disease according to RECIST 1.1 guidelines.I have a condition that causes me to bleed easily.My cancer has a specific EGFR mutation.I am allergic to zipalertinib or similar medications.I have a history of lung disease not related to cancer.I have hepatitis B, C, or HIV that is not well-controlled with treatment.My lung cancer is advanced or has spread, and fits into one of the specific groups A, B, C, or D.My condition worsened after treatment targeting a specific mutation.I don't have serious side effects from cancer treatment, except maybe hair loss or skin color changes.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort D ("other uncommon EGFRmt").
- Group 2: Cohort C ("active brain mets")
- Group 3: Cohort A ("prior ex20ins treatment")
- Group 4: Cohort B ("1st line treatment")
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies in this clinical trial?
"According to clinicaltrials.gov, this research project began on July 7th 2023 and is currently open for recruitment of participants. It was most recently updated two weeks ago (July 21st)."
Answered by AI
Are individuals at risk when utilizing the Cohort A ("prior ex20ins treatment") protocol?
"Our team has rated Cohort A's safety as a 2, due to the Phase 2 trial lacking evidence for efficacy but having limited data in support of its security."
Answered by AI
What is the current enrollment capacity for this research study?
"Correct. This trial, posted on July 7th 2023, is presently enrolling participants for the study. One medical centre will be recruiting 160 patients in total."
Answered by AI
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