← Back to Search

Tyrosine Kinase Inhibitor

Zipalertinib for Non-Small Cell Lung Cancer (REZILIENT2 Trial)

Phase 2
Waitlist Available
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
Must not have
Received Zipalertinib (TAS6417/CLN081) at any time
Major surgery (excluding placement of vascular access) ≤28 days prior to the first dose of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
No Placebo-Only Group

Summary

This Trial is testing zipalertinib, a new drug, in patients with advanced lung cancer that has specific genetic changes. The drug aims to stop cancer growth by blocking faulty proteins. The study involves patients with different backgrounds and genetic profiles.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has a specific EGFR mutation, not the ex20ins type.
Select...
I can provide samples of my tumor for research.
Select...
I have brain metastases.
Select...
I haven't had systemic therapy for my advanced disease.
Select...
I am fully active or can carry out light work.
Select...
My cancer has a specific EGFR mutation.
Select...
My condition worsened after treatment targeting a specific mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have taken Zipalertinib (TAS6417/CLN081) before.
Select...
I have not had major surgery in the last 4 weeks.
Select...
I have heart problems that affect my daily activities.
Select...
I had COVID-19 or its symptoms within the last 4 weeks.
Select...
I cannot swallow pills or have a condition affecting how my body absorbs medication.
Select...
I have a condition that causes me to bleed easily.
Select...
I am allergic to zipalertinib or similar medications.
Select...
I have a history of lung disease not related to cancer.
Select...
I have hepatitis B, C, or HIV that is not well-controlled with treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
All Cohorts: Overall Survival (OS)
All Cohorts: Pharmacokinetic (PK) parameter
Other study objectives
EGFR mutation status
Pharmacokinetic (PK) parameter

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. EGFR inhibitors, such as zipalertinib, work by blocking the epidermal growth factor receptor (EGFR) pathway, which is often mutated in NSCLC, leading to uncontrolled cell growth. By inhibiting this pathway, these drugs can slow down or stop the progression of the cancer. Other targeted therapies focus on different mutations like ALK, ROS1, and BRAF, each blocking specific pathways critical for cancer cell survival. Immunotherapies, such as checkpoint inhibitors, enhance the body's immune response against cancer cells. These treatments are significant for NSCLC patients as they offer more personalized and effective options, especially for those with specific genetic mutations, leading to better outcomes and potentially fewer side effects compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

Taiho Oncology, Inc.Lead Sponsor
78 Previous Clinical Trials
12,880 Total Patients Enrolled

Media Library

Zipalertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05967689 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Cohort C ("active brain mets"), Cohort D ("other uncommon EGFRmt")., Cohort A ("prior ex20ins treatment"), Cohort B ("1st line treatment")
Non-Small Cell Lung Cancer Clinical Trial 2023: Zipalertinib Highlights & Side Effects. Trial Name: NCT05967689 — Phase 2
Zipalertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05967689 — Phase 2
~42 spots leftby Jun 2025