Actively Recruiting
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.
Led by Taiho Oncology, Inc. · Updated on 2026-04-03
220
Participants Needed
80
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent.
- Be 18 years or older (or meet legal adult age in your country).
- Have pathologically confirmed locally advanced or metastatic NSCLC with EGFR exon 20 insertion or other uncommon EGFR mutations confirmed by certified local testing.
- For Cohort A: Have progressed after prior systemic therapy including ex20ins-targeted agents and chemotherapy; stable brain metastases if present.
- For Cohort B: No prior treatment for advanced disease and not suitable or refused first-line doublet platinum-based chemotherapy; stable brain metastases if present.
- For Cohort C: Have active brain metastases or leptomeningeal disease measurable by standard criteria; may have had prior treatment.
- For Cohort D: Have other uncommon EGFR mutations excluding C797S; no prior systemic therapy for advanced disease; stable brain metastases if present.
- Have measurable disease per RECIST 1.1.
- Have archival tumor tissue available for mutation status evaluation.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Adequate organ function as defined by laboratory tests.
- Women of childbearing potential must have a negative pregnancy test before treatment.
- Both males and females of reproductive potential must agree to use effective contraception during and for one month after treatment.
- For DDI substudy: Confirmed advanced NSCLC with specified EGFR mutations and prior systemic therapy unless no approved therapy or intolerant/refused.
- For dose optimization substudy: Confirmed EGFR exon 20 insertion NSCLC with progression after platinum-based chemotherapy; measurable CNS lesions stable or asymptomatic; ECOG PS 0 or 1; adequate organ function.
You will not qualify if you...
- Currently receiving an investigational drug or participating in incompatible medical research.
- Prior treatment with zipalertinib (TAS6417/CLN081).
- Recent CNS radiotherapy (within 12 weeks), thoracic radiotherapy (within 28 days), or other palliative radiation (within 14 days).
- Recent anticancer immunotherapy or major surgery within 28 days before first dose.
- Prior treatment with any EGFR exon 20 insertion-targeted tyrosine kinase inhibitor.
- Presence of leptomeningeal CNS disease.
- Unresolved toxicity grade 2 or higher from previous cancer treatment except alopecia or skin pigmentation.
- History of interstitial lung disease, treatment-related pneumonitis, or active interstitial lung disease.
- Significant cardiac disease including advanced congestive heart failure, serious arrhythmias, or prolonged QT interval over 470 msec.
- Unable to swallow tablets or conditions affecting drug absorption.
- History of another primary malignancy within 2 years unless adequately treated and stable.
- Uncontrolled hepatitis B, hepatitis C, or HIV infection.
- COVID-19 infection within 4 weeks prior to enrollment or persistent pulmonary symptoms.
- Active bleeding disorders.
- Known allergy to zipalertinib or similar drugs.
- Pregnant, breastfeeding, or planning pregnancy.
- Unable or unwilling to comply with study procedures.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 80 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Withdrawn
2
City of Hope - Duarte
Duarte, California, United States, 91010
Actively Recruiting
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Comprehensive Cancer Centers of Nevada - Central Valley - Twain
Las Vegas, Nevada, United States, 89169
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center - Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center - Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center - Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, United States, 11725
Actively Recruiting
9
Memorial Sloan Kettering Cancer Center - Westchester
Harrison, New York, United States, 10604
Actively Recruiting
10
MSK Cancer Center
Long Island City, New York, United States, 11101
Actively Recruiting
11
Memorial Sloan Kettering Cancer Center - Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
12
Gabrail Cancer and Research Center
Canton, Ohio, United States, 44718
Active, Not Recruiting
13
Zangmeister Cancer Center
Columbus, Ohio, United States, 43219
Withdrawn
14
The Toledo Clinic Cancer Center
Toledo, Ohio, United States, 43623
Withdrawn
15
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
16
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
17
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
18
IDS Pharmacy
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
19
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia, 2200
Actively Recruiting
20
Genesis Care North Shore
Saint Leonards, New South Wales, Australia, 2065
Actively Recruiting
21
Joondalup Hospital Pharmacy
Joondalup, Western Australia, Australia, 6027
Actively Recruiting
22
William Osler Health System - Brampton Civic Hospital
Brampton, Canada, L6R 3J7
Actively Recruiting
23
Nouvel Hôpital Civil
Strasbourg, Aslace, France, 67091
Actively Recruiting
24
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, France, 69008
Actively Recruiting
25
CHU Caen Normandie
Caen, Basse-Normandie, France, 14033
Actively Recruiting
26
Centre Hospitalier Universitaire Limoges
Limoges, Limousin, France, 87042
Actively Recruiting
27
Hopital Haut Leveque
Pessac, New Aquitaine, France, 33604
Actively Recruiting
28
Hôpital Nord de Marseille
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13015
Actively Recruiting
29
Hopital Nord Laennec
Saint-Herblain, France, 44800
Actively Recruiting
30
Hopital Ambroise Pare
Boulogne-Billancourt, Île-de-France Region, France, 92100
Actively Recruiting
31
Institut Curie
Paris, Île-de-France Region, France, 75005
Actively Recruiting
32
Gesundheit Nordhessen Holding AG
Kassel, Hassen, Germany, 34125
Actively Recruiting
33
Uniklinik Dresden
Dresden, Germany, 01307
Actively Recruiting
34
UKGM Studienzentrale
Giessen, Germany, 35392
Actively Recruiting
35
UKR Innere Med II Pneumologie
Regensburg, Germany, 93053
Withdrawn
36
Queen Mary Hospital
Pok Fu Lam, Hong Kong Island, Hong Kong
Active, Not Recruiting
37
Azienda Ospedaliero - Universitaria Careggi
Florence, Florence, Italy, 50134
Actively Recruiting
38
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola, Forli-Cesena, Italy, 47014
Actively Recruiting
39
Azienda Socio-Sanitaria Territoriale di Cremona
Cremona, Italy, 26100
Actively Recruiting
40
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
41
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy, 43126
Actively Recruiting
42
Ospedale S. Maria delle Croci
Ravenna, Italy, 48121
Actively Recruiting
43
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
44
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
45
NHO Kyushu Cancer Center
Fukuoka, Hukuoka, Japan, 811-1395
Actively Recruiting
46
Sendai Kousei Hospital
Sendai, Miyagi, Japan, 980-0873
Actively Recruiting
47
Niigata Cancer Center Hospital
Niigata, Niigata, Japan, 951-8566
Actively Recruiting
48
Kindai University Hospital
Sayama, Osaka, Japan, 589-8511
Actively Recruiting
49
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan, 411-8777
Actively Recruiting
50
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan, 104-0045
Actively Recruiting
51
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
52
Okayama University Hospital
Okayama, Japan, 700-8558
Actively Recruiting
53
National Cancer Center - Korea
Goyang-si, Gyeonggi-do, South Korea, 10408
Withdrawn
54
Saint Vincent's Hospital
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
55
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea, 16499
Actively Recruiting
56
Gyeongsang National University Hospital
Jinju, Gyeongsangnamdo [Kyongsangnam-do], South Korea, 52727
Actively Recruiting
57
Inha University Hospital
Incheon, Incheon Gwang'yeogsi [Inch'on-Kwangyokshi], South Korea, 22332
Actively Recruiting
58
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, South Korea, 58128
Actively Recruiting
59
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 03080
Active, Not Recruiting
60
Asan Medical Center
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 05505
Actively Recruiting
61
Korea University Guro Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 08308
Actively Recruiting
62
Seoul St. Mary's Hospital
Soeul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 06591
Withdrawn
63
Hospital Regional Universitario de Málaga - Hospital General
Málaga, Malaga, Spain, 29010
Actively Recruiting
64
UOMi Clinica Mi Tres Torres
Barcelona, Spain, 08017
Actively Recruiting
65
Hospital Quirónsalud Barcelona
Barcelona, Spain, 08023
Actively Recruiting
66
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
67
Complejo Hospitalario de Jaen
Jaén, Spain, 23007
Actively Recruiting
68
MD Anderson Cancer Center Madrid
Madrid, Spain, 28033
Actively Recruiting
69
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
70
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
71
Hospital La Paz
Madrid, Spain, 28046
Actively Recruiting
72
Istinye Üniversite Hastanesi Liv Hospital Bahcesehir
Esenyurt, Istanbul, Turkey (Türkiye), 34517
Actively Recruiting
73
Medical Park Seyhan Hastanesi
Adana, Turkey (Türkiye), 01140
Actively Recruiting
74
Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi
Edirne, Turkey (Türkiye), 22030
Actively Recruiting
75
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, Turkey (Türkiye), 34214
Withdrawn
76
Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, Turkey (Türkiye), 34722
Actively Recruiting
77
The Royal Free Hospital NHS Foundation Trust
Barnet, England, United Kingdom, EN5 3DJ
Actively Recruiting
78
Royal Free London NHS Foundation Trust
London, England, United Kingdom, NW3 2QG
Actively Recruiting
79
The Christie NHS Foundation Trust
Manchester, England, United Kingdom, M20 4BX
Actively Recruiting
80
Nottingham University Hospitals NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Actively Recruiting
Research Team
T
Taiho Oncology, INC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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