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Tyrosine Kinase Inhibitor

Zipalertinib + Chemotherapy for Non-Small Cell Lung Cancer (REZILIENT3 Trial)

Phase 3

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 EGFR mutation status, as determined by local testing performed at a CLIA certified or equivalent laboratory, defined as follows: Part A: ex20ins or other common single or compound EGFR mutation, Part B: ex20ins EGFR mutation

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Must not have

Impaired cardiac function or clinically significant cardiac disease, including any of the following: History of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification, Serious cardiac arrhythmias requiring treatment, Resting corrected QT interval (QTc) >470 msec calculated using Fridericia's formula (QTcF)

Past medical history of interstitial lung disease, treatment-related pneumonitis (any grade), or any evidence of clinically active interstitial lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test if combining a drug with chemo for lung cancer with EGFR mutations is more effective than chemo alone.

Who is the study for?

Adults with advanced non-small cell lung cancer (NSCLC) that have a specific mutation called EGFR exon 20 insertion. They must be over 18, have stable brain metastases if present, an ECOG performance status of 0 or 1, and a life expectancy of at least three months. Participants should not have had prior systemic treatment for their NSCLC except certain adjuvant/neoadjuvant therapies over six months ago.

What is being tested?

The trial is testing the effectiveness and safety of a new drug named Zipalertinib in combination with standard platinum-based chemotherapy versus chemotherapy alone in patients with advanced NSCLC harboring the EGFR exon 20 insertion mutation.

What are the potential side effects?

While specific side effects for Zipalertinib are not listed here, common side effects from similar treatments may include nausea, fatigue, increased risk of infection, potential liver issues, and reactions related to infusion.

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.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My lung cancer is advanced but not squamous type.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious heart problems, including heart failure or irregular heartbeat.

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I have had lung conditions like interstitial lung disease or inflammation due to treatment.

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

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I have a condition that causes me to bleed easily.

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I cannot or will not take dexamethasone, folic acid, or vitamin B12 with pemetrexed.

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My hepatitis B/C or HIV is not controlled despite treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 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

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30

European Quality of Life 5 Dimensions, 3 Level Version (EQ-5D-3L)

Non-small Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ )

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part BExperimental Treatment1 Intervention

Enrollment into the Phase 3 portion of the study will begin following completion of Part A. Approximately 260 patients will be randomized on a 1:1 basis to receive pemetrexed and a platinum agent (either carboplatin or cisplatin) with or without zipalertinib on a 21-day cycle. Carboplatin or cisplatin will be administered for 4 cycles. Patients may continue to receive zipalertinib (experimental study arm) and pemetrexed (both study arms) until documentation of PD or until other withdrawal criteria are met, whichever comes first.

Group II: Part A (Safety Lead in)Experimental Treatment1 Intervention

Part A: Safety Lead-In Approximately 6-12 patients will receive zipalertinib administered at an initial dose of zipalertinib PO BID (Dose Level 1) in combination with pemetrexed and carboplatin or cisplatin on a 21-day cycle. Patients may continue to receive study treatment until documentation of progressive disease (PD) or until other withdrawal criteria are met, whichever comes first.

0 / 9Eligibility criteria met