A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.

ClinicalTrials.gov ID: NCT05967689

Public ClinicalTrials.gov record NCT05967689. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 4:06 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and other mutations.

Study identification

NCT ID: NCT05967689
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Taiho Oncology, Inc.; Industry
Enrollment: 220 participants

Conditions and interventions

Conditions

Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 30, 2023
Primary completion: Aug 30, 2028
Completion: Dec 30, 2028
Last update posted: Aug 31, 2026

2023 – 2028

United States locations

U.S. sites: 18
U.S. states: 11
U.S. cities: 18

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham	Birmingham	Alabama	35294	Withdrawn
City of Hope - Duarte	Duarte	California	91010	Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	02215	Recruiting
Comprehensive Cancer Centers of Nevada - Central Valley - Twain	Las Vegas	Nevada	89169	Recruiting
Memorial Sloan Kettering Cancer Center - Basking Ridge	Basking Ridge	New Jersey	07920	Recruiting
Memorial Sloan Kettering Cancer Center - Monmouth	Middletown	New Jersey	07748	Recruiting
Memorial Sloan Kettering Cancer Center - Bergen	Montvale	New Jersey	07645	Recruiting
Memorial Sloan Kettering Cancer Center - Commack	Commack	New York	11725	Recruiting
Memorial Sloan Kettering Cancer Center - Westchester	Harrison	New York	10604	Recruiting
MSK Cancer Center	Long Island City	New York	11101	Recruiting
Memorial Sloan Kettering Cancer Center - Nassau	Uniondale	New York	11553	Recruiting
Gabrail Cancer and Research Center	Canton	Ohio	44718	Recruiting
Zangmeister Cancer Center	Columbus	Ohio	43219	Withdrawn
The Toledo Clinic Cancer Center	Toledo	Ohio	43623	Withdrawn
SCRI Oncology Partners	Nashville	Tennessee	37203	Recruiting
University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
Virginia Cancer Specialists	Fairfax	Virginia	22031	Recruiting
IDS Pharmacy	Milwaukee	Wisconsin	53226	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 62 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05967689, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 31, 2026 · Synced Sep 5, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05967689 live on ClinicalTrials.gov.

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