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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

REZILIENT3 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.Check my eligibility

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.See study design

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.

REZILIENT3 Trial 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.

REZILIENT3 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A and B: The rate and severity of treatment emergent AEs

Part A and Part B: Progression-free survival (PFS) by blinded independent central review (BICR)

Part A: The rate and severity of DLTs according to the NCI-Common Terminology Criteria of Adverse Events (CTCAE) v5.0 during Cycle 1

Secondary outcome measures

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 )

+7 more

Other outcome measures

EGFR mutation status

Pharmacokinetic (PK) parameter

REZILIENT3 Trial Design

2Treatment groups

Experimental Treatment

Group I: Part BExperimental Treatment1 Intervention

Part B: Phase 3 Enrollment into the Phase 3 portion of the study will begin following completion of Part A. Approximately 300 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Taiho Oncology, Inc.Lead Sponsor

66 Previous Clinical Trials

11,272 Total Patients Enrolled

Media Library

Zipalertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05973773 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Part A (Safety Lead in) obtained the necessary authorization from the FDA?

"Our team at Power have allocated a score of 3 to Part A (Safety Lead in) as it is currently classified as Phase 3, implying there has been both efficacy and safety data collected."

Answered by AI

What is the participant capacity for this clinical trial?

"Absolutely. Clinicaltrials.gov denoting that this clinical investigation is presently enrolling patients, with the trial's initial posting on June 26th 2023 and its most recent amendment occurring July 25th 2023. A total of 312 participants are needed at a single facility."

Answered by AI

Is recruitment still open for this investigation?

"Clinicaltrials.gov indicates that this medical study is still actively recruiting participants, beginning on June 26th 2023 and last edited July 25th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Zipalertinib and Chemotherapy Compared With Chemotherapy Alone in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion.

2023. "A Study of Zipalertinib and Chemotherapy Compared With Chemotherapy Alone in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05973773.

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