RecruitingPhase 2NCT05967689

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.

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.


Sponsor

Taiho Oncology, Inc.

Enrollment

220 participants

Start Date

Jul 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called zipalertinib in people with advanced or metastatic non-small cell lung cancer (a type of lung cancer that has spread or cannot be removed with surgery). The cancer must have a specific gene change called an EGFR mutation — either an "exon 20 insertion" or another uncommon type. The study is looking at whether zipalertinib is safe and effective for people who have already tried other targeted treatments, as well as for some people who are starting treatment for the first time. **You may be eligible if...** - You have advanced or metastatic non-small cell lung cancer with an EGFR exon 20 insertion or uncommon EGFR mutation confirmed by lab testing - You are 18 years or older - You have already tried a targeted therapy for the EGFR exon 20 mutation (for some groups), or you haven't yet received treatment for advanced disease (for other groups) - If you have brain metastases, they are stable and you've had brain-directed treatment at least 4 weeks ago - You are well enough to carry out daily activities (good performance status) **You may NOT be eligible if...** - You have previously taken zipalertinib - You have a history of serious lung scarring (interstitial lung disease) - You have significant heart problems, including irregular heartbeat or abnormal heart electrical activity - You have uncontrolled brain or spinal fluid cancer spread (leptomeningeal disease) - You are pregnant or breastfeeding - You are currently in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTAS6417

Oral tablets

DRUGCYP Cocktail

Single dose of CYP enzyme probe substrates (CYP cocktail) alone prior to the start of zipalertinib dosing and a single dose of CYP cocktail in combination with zipalertinib at steady state.

DRUGTransporter Cocktail

Single dose of transporter probe substrates (Transporter cocktail) alone prior to the start of zipalertinib dosing and a single dose of Transporter cocktail in combination with zipalertinib at steady state.


Locations(80)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope - Duarte

Duarte, California, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Comprehensive Cancer Centers of Nevada - Central Valley - Twain

Las Vegas, Nevada, United States

Memorial Sloan Kettering Cancer Center - Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Commack

Commack, New York, United States

Memorial Sloan Kettering Cancer Center - Westchester

Harrison, New York, United States

MSK Cancer Center

Long Island City, New York, United States

Memorial Sloan Kettering Cancer Center - Nassau

Uniondale, New York, United States

Gabrail Cancer and Research Center

Canton, Ohio, United States

Zangmeister Cancer Center

Columbus, Ohio, United States

The Toledo Clinic Cancer Center

Toledo, Ohio, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

IDS Pharmacy

Milwaukee, Wisconsin, United States

Bankstown-Lidcombe Hospital

Bankstown, New South Wales, Australia

Genesis Care North Shore

Saint Leonards, New South Wales, Australia

Joondalup Hospital Pharmacy

Joondalup, Western Australia, Australia

William Osler Health System - Brampton Civic Hospital

Brampton, Canada

Nouvel Hôpital Civil

Strasbourg, Aslace, France

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France

CHU Caen Normandie

Caen, Basse-Normandie, France

Centre Hospitalier Universitaire Limoges

Limoges, Limousin, France

Hopital Haut Leveque

Pessac, New Aquitaine, France

Hôpital Nord de Marseille

Marseille, Provence-Alpes-Côte d'Azur Region, France

Hopital Nord Laennec

Saint-Herblain, France

Hopital Ambroise Pare

Boulogne-Billancourt, Île-de-France Region, France

Institut Curie

Paris, Île-de-France Region, France

Gesundheit Nordhessen Holding AG

Kassel, Hassen, Germany

Uniklinik Dresden

Dresden, Germany

UKGM Studienzentrale

Giessen, Germany

UKR Innere Med II Pneumologie

Regensburg, Germany

Queen Mary Hospital

Pok Fu Lam, Hong Kong Island, Hong Kong

Azienda Ospedaliero - Universitaria Careggi

Florence, Florence, Italy

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST

Meldola, Forli-Cesena, Italy

Azienda Socio-Sanitaria Territoriale di Cremona

Cremona, Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

Ospedale S. Maria delle Croci

Ravenna, Italy

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

NHO Kyushu Cancer Center

Fukuoka, Hukuoka, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Kindai University Hospital

Sayama, Osaka, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Okayama University Hospital

Okayama, Japan

National Cancer Center - Korea

Goyang-si, Gyeonggi-do, South Korea

Saint Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Gyeongsang National University Hospital

Jinju, Gyeongsangnamdo [Kyongsangnam-do], South Korea

Inha University Hospital

Incheon, Incheon Gwang'yeogsi [Inch'on-Kwangyokshi], South Korea

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Asan Medical Center

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Korea University Guro Hospital

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Seoul St. Mary's Hospital

Soeul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Hospital Regional Universitario de Málaga - Hospital General

Málaga, Malaga, Spain

UOMi Clinica Mi Tres Torres

Barcelona, Spain

Hospital Quirónsalud Barcelona

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Complejo Hospitalario de Jaen

Jaén, Spain

MD Anderson Cancer Center Madrid

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital La Paz

Madrid, Spain

Istinye Üniversite Hastanesi Liv Hospital Bahcesehir

Esenyurt, Istanbul, Turkey (Türkiye)

Medical Park Seyhan Hastanesi

Adana, Turkey (Türkiye)

Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi

Edirne, Turkey (Türkiye)

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, Turkey (Türkiye)

Prof. Dr. Suleyman Yalcin Sehir Hastanesi

Istanbul, Turkey (Türkiye)

The Royal Free Hospital NHS Foundation Trust

Barnet, England, United Kingdom

Royal Free London NHS Foundation Trust

London, England, United Kingdom

The Christie NHS Foundation Trust

Manchester, England, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, England, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05967689