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.

PHASE2RecruitingINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

July 31, 2023

Primary Completion Date

February 28, 2026

Study Completion Date

August 31, 2026

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

TAS6417

Oral tablets

DRUG

CYP 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.

DRUG

Transporter 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.

Trial Locations (80)

2065

RECRUITING

Genesis Care North Shore, Saint Leonards

2200

RECRUITING

Bankstown-Lidcombe Hospital, Bankstown

6027

RECRUITING

Joondalup Hospital Pharmacy, Joondalup

10408

WITHDRAWN

National Cancer Center - Korea, Goyang-si

10604

RECRUITING

Memorial Sloan Kettering Cancer Center - Westchester, Harrison

11101

RECRUITING

MSK Cancer Center, Long Island City

11553

RECRUITING

Memorial Sloan Kettering Cancer Center - Nassau, Uniondale

11725

RECRUITING

Memorial Sloan Kettering Cancer Center - Commack, Commack

13015

RECRUITING

Hôpital Nord Marseille, Marseille

14033

RECRUITING

CHU Caen Normandie, Caen

16247

RECRUITING

Saint Vincent's Hospital, Suwon

16499

RECRUITING

Ajou University Hospital, Suwon

20132

RECRUITING

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

22030

RECRUITING

Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi, Edirne

22031

RECRUITING

Virginia Cancer Specilalist, Fairfax

22332

RECRUITING

Inha University Hospital, Incheon

23007

RECRUITING

Complejo Hospitalario de Jaen, Jaén

26100

RECRUITING

Azienda Socio-Sanitaria Territoriale di Cremona, Cremona

28033

RECRUITING

MD Anderson Cancer Center Madrid, Madrid

28040

RECRUITING

Hospital Universitario Fundación Jiménez Díaz, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28046

RECRUITING

Hospital La Paz, Madrid

29010

RECRUITING

Hospital Regional Universitario de Málaga - Hospital General, Málaga

33604

ACTIVE_NOT_RECRUITING

Hopital Haut Leveque, Pessac

34125

RECRUITING

Gesundheit Nordhessen Holding AG, Kassel

34214

RECRUITING

Bagcilar Medipol Mega Universite Hastanesi, Istanbul

34517

RECRUITING

Istinye Üniversite Hastanesi Liv Hospital Bahcesehir, Esenyurt

34722

RECRUITING

Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Istanbul

35294

WITHDRAWN

University of Alabama at Birmingham, Birmingham

35392

RECRUITING

UKGM Studienzentrale, Giessen

37203

RECRUITING

SCRI Oncology Partners, Nashville

43126

RECRUITING

Azienda Ospedaliero-Universitaria di Parma, Parma

43219

WITHDRAWN

Zangmeister Cancer Center, Columbus

43623

WITHDRAWN

The Toledo Clinic Cancer Center, Toledo

44718

RECRUITING

Gabrail Cancer and Research Center, Canton

44800

RECRUITING

Hopital Nord Laennec, Saint-Herblain

47014

RECRUITING

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

48121

RECRUITING

Ospedale S. Maria delle Croci, Ravenna

50134

RECRUITING

Azienda Ospedaliero - Universitaria Careggi, Florence

52727

RECRUITING

Gyeongsang National University Hospital, Jinju

53226

RECRUITING

IDS Pharmacy, Milwaukee

58128

RECRUITING

Chonnam National University Hwasun Hospital, Hwasun-gun

67091

RECRUITING

Nouvel Hôpital Civil, Strasbourg

69008

RECRUITING

Centre Leon Berard, Lyon

75005

RECRUITING

Institut Curie, Paris

77030

RECRUITING

University of Texas MD Anderson Cancer Center, Houston

87042

RECRUITING

Centre Hospitalier Universitaire Limoges, Limoges

89169

RECRUITING

Comprehensive Cancer Centers of Nevada, Las Vegas

91010

RECRUITING

City of Hope - Duarte, Duarte

92100

RECRUITING

Hopital Ambroise Pare, Boulogne-Billancourt

93053

WITHDRAWN

UKR Innere Med II Pneumologie, Regensburg

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

07920

RECRUITING

Memorial Sloan Kettering Cancer Center - Basking Ridge, Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Cancer Center - Monmouth, Middletown

07645

RECRUITING

Memorial Sloan Kettering Cancer Center - Bergen, Montvale

L6R 3J7

RECRUITING

William Osler Health System - Brampton Civic Hospital, Brampton

01307

RECRUITING

Uniklinik Dresden, Dresden

Unknown

ACTIVE_NOT_RECRUITING

Queen Mary Hospital, Pok Fu Lam

464-8681

RECRUITING

Aichi Cancer Center, Nagoya

277-8577

RECRUITING

National Cancer Center Hospital East, Kashiwa-shi

811-1395

RECRUITING

NHO Kyushu Cancer Center, Fukuoka

980-0873

RECRUITING

Sendai Kousei Hospital, Sendai

951-8566

RECRUITING

Niigata Cancer Center Hospital, Niigata

589-8511

RECRUITING

Kindai University Hospital, Sayama

411-8777

RECRUITING

Shizuoka Cancer Center, Sunto-gun

104-0045

RECRUITING

National Cancer Center Hospital, Chuo Ku

135-8550

RECRUITING

Cancer Institute Hospital of JFCR, Koto-ku

700-8558

RECRUITING

Okayama University Hospital, Okayama

03080

ACTIVE_NOT_RECRUITING

Seoul National University Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

08308

RECRUITING

Korea University Guro Hospital, Seoul

06591

RECRUITING

Seoul St. Mary's Hospital, Soeul

08017

RECRUITING

UOMi Clinica Mi Tres Torres, Barcelona

08023

RECRUITING

Hospital Quirónsalud Barcelona, Barcelona

08036

RECRUITING

Hospital Clinic de Barcelona, Barcelona

01140

RECRUITING

Medical Park Seyhan Hastanesi, Adana

EN5 3DJ

ACTIVE_NOT_RECRUITING

The Royal Free Hospital NHS Foundation Trust, Barnet

NW3 2QG

RECRUITING

Royal Free London NHS Foundation Trust, London

M20 4BX

RECRUITING

The Christie NHS Foundation Trust, Manchester

NG5 1PB

RECRUITING

Nottingham University Hospitals NHS Trust, Nottingham

All Listed Sponsors
lead

Taiho Oncology, Inc.

INDUSTRY