Zipalertinib for Non-Small Cell Lung Cancer

(REZILIENT2 Trial)

Recruiting at 160 trial locations

Overseen By Taiho Oncology, INC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Taiho Oncology, Inc.

Must not be taking: CYP3A4 inducers, inhibitors

Disqualifiers: Uncontrolled seizures, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Until progression or withdrawal

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I can provide samples of my tumor for research.

I am at least 18 years old or considered an adult by my country's laws.

I have brain metastases.

Exclusion Criteria

I had chest radiation therapy less than 28 days ago or palliative radiation less than 14 days ago.

I haven't had cancer immunotherapy in the last 28 days.

I have taken Zipalertinib (TAS6417/CLN081) before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zipalertinib orally twice a day (BID) continuously until documentation of progression or withdrawal criteria are met

Until progression or withdrawal

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Zipalertinib

Trial Overview 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.

Participant Groups

Group I: Cohort D ("other uncommon EGFRmts"). Experimental Treatment 1 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 Treatment 1 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 ("first-line treatment") Experimental Treatment 1 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 Treatment 1 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.

Who Is Running the Clinical Trial?

Taiho Oncology, Inc.

Lead Sponsor

Trials

79

Recruited

12,700+

Tim Whitten

Taiho Oncology, Inc.

Chief Executive Officer since 2018

MBA and Pharmacy degree

Harold Keer

Taiho Oncology, Inc.

Chief Medical Officer

MD, PhD