What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include EGFR inhibitors like gefitinib and investigational drugs like zipalertinib. Known side effects of EGFR inhibitors can include skin rash, diarrhea, and liver function abnormalities. Other treatments such as chemotherapy (e.g., carboplatin, paclitaxel) and immunotherapy (e.g., pembrolizumab, atezolizumab) also have notable side effects. Chemotherapy often causes neutropenia, fatigue, and nausea, while immunotherapy can lead to immune-related adverse events such as pneumonitis, colitis, and hepatitis. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Several FDA-approved treatments target EGFR mutations in NSCLC. These include osimertinib, which is approved for first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Additionally, afatinib and gefitinib are approved for first-line treatment of patients with metastatic NSCLC with specific EGFR mutations. For patients with HER2 exon-20-insertion mutations, fam-trastuzumab deruxtecan is approved. Other targeted therapies include sotorasib and adagrasib for KRAS G12C-mutated NSCLC. These treatments highlight the focus on personalized, genotype-directed therapy in managing advanced NSCLC.

What other types of research exist?

Promising alternatives to Zipalertinib for NSCLC patients include: 1) Osimertinib, which is considered the best first-line option for EGFR activating mutations based on the FLAURA study. 2) Next-generation ALK inhibitors, which have shown improved efficacy and resistance management in ALK-rearranged NSCLC. 3) Pembrolizumab combined with chemotherapy, which has demonstrated significant overall survival benefits in PD-L1-unselected, advanced squamous NSCLC.

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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

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

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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.

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My cancer has a specific EGFR mutation.

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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:

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I have taken Zipalertinib (TAS6417/CLN081) before.

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I have not had major surgery in the last 4 weeks.

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I have heart problems that affect my daily activities.

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I had COVID-19 or its symptoms within the last 4 weeks.

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I cannot swallow pills or have a condition affecting how my body absorbs medication.

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I have a condition that causes me to bleed easily.

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I am allergic to zipalertinib or similar medications.

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I have a history of lung disease not related to cancer.

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I have hepatitis B, C, or HIV that is not well-controlled with treatment.

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

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.

0 / 16Eligibility criteria met

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.