AzTrials
AzTrials

Advanced or Metastatic NSCLS With Exon 20 Insertion MutationPhase 3REZILIENT3NCT05973773

REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

A Phase 3 study testing TAS6417 in people with Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation, run by Taiho Oncology, Inc. at 110 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy compared to chemotherapy alone, in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TAS6417
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
285 participants
Where
110 sitesin 22 countries
Study dates
18 Dec 2023to 27 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide written informed consent.
  • ≥18 years of age (or meets the country's regulatory definition for legal adult age, whichever is greater).
  • Pathologically confirmed, locally advanced or metastatic nonsquamous NSCLC
  • Has not received any prior systemic treatment for their locally advanced or metastatic nonsquamous NSCLC. Prior adjuvant/neoadjuvant treatment received >6 months prior to first dose of study treatment is allowed for early-stage
  • NSCLC. Prior monotherapy with an approved EGFR TKI (ie, gefitinib, erlotinib, afatinib, dacomitinib, or osimertinib) as nonstandard first-line therapy for the treatment of locally advanced or metastatic disease is allowed if all of the following criteria are met:
  • Treatment duration did not exceed 8 weeks;
Show all 22Show fewer
  • Lack of disease response was documented (radiographically) by an increase in tumor burden (a copy of the computerized tomography [CT] report showing increase in tumor burden from baseline should be submitted);
  • Associated toxicities have resolved to baseline; and
  • The EGFR TKI was discontinued at least 2 weeks or 4 half-lives prior to randomization, whichever is longer.
  • Prior therapy with EGFR TKI agents targeting exon20ins mutations including amivantamab, mobocertinib, sunvozertinib, furmonertinib, and poziotinib is not allowed.
  • Documented EGFR mutation status, as determined by local testing performed at a CLIA certified (US) or accredited (outside of the US) local laboratory, defined as follows:
  • Part A: EGFR ex20ins or other uncommon single or compound EGFR mutation
  • Part B: EGFR ex20ins mutation
  • Archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFR mutation status and, where possible, other biomarkers. Patients with insufficient tissue (details provided in laboratory manual) may be eligible following discussion with the sponsor; a fresh biopsy will not be required.
  • Patients with brain metastasis(es) who have previously received definitive local treatment and have stable central nervous system (CNS) disease (defined as being neurologically stable and off corticosteroid for at least 2 weeks prior to enrollment) are eligible. If brain metastases are diagnosed on screening imaging, the patient may be rescreened for eligibility after definitive treatment.
  • Asymptomatic brain metastases ≤2 cm in size can be eligible for inclusion if, in the opinion of the Investigator, immediate definitive treatment is not indicated.
  • At least one measurable lesion as determined per RECIST 1.1 for patients enrolling to Part B. Patients enrolling to Part A may be enrolled without measurable disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Adequate organ function, as defined by the laboratory value
  • Have a life expectancy of at least 3 months as assessed by the investigator.
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test prior to administration of the first dose of study treatment. Female patients are not considered to be of childbearing potential if they are postmenopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
  • Both males and females of reproductive potential must agree to use effective birth control during the study prior to the first dose and for 6 months after the last dose of study treatment or longer, based on local requirements.

Who cannot join

  • Is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Prior treatment with any of the following within the specific time frame specified:
  • Zipalertinib (TAS6417/CLN-081) at any time.
  • Thoracic radiotherapy ≤28 days, palliative radiation of nonthoracic disease ≤14 days, or palliative radiation of a single lesion ≤7 days prior to first dose of study treatment.
  • Major surgery (excluding placement of vascular access) ≤28 days prior to first dose of study treatment.
  • All prescribed medication, over-the-counter medication, vitamin preparations and other food supplements, or herbal medications that are strong or moderate CYP3A4 inducers or inhibitors within 7 days prior to first dose.
Show all 26Show fewer
  • Have any unresolved toxicity of Grade ≥2 from previous anticancer treatment in the neoadjuvant or adjuvant setting, except for Grade 2 alopecia or skin pigmentation. Patients with other chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the investigator and Sponsor.
  • Past medical history of interstitial lung disease, treatment-related pneumonitis (any grade), or any evidence of clinically active interstitial lung disease.
  • Impaired cardiac function or clinically significant cardiac disease, including any of the following:
  • History of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification .
  • Serious cardiac arrhythmias requiring treatment.
  • Resting corrected QT interval (QTc) >470 msec calculated using Fridericia's formula (QTcF).
  • Unable to swallow tablets or has any disease or condition that may significantly affect gastrointestinal (GI) absorption of zipalertinib (such as inflammatory bowel disease, malabsorption syndrome, or prior GI resection).
  • History of another primary malignancy ≤2 years prior to the date of first dose of study treatment unless at least one of the following criteria are met:
  • Adequately treated basal or squamous cell carcinoma of the skin
  • Cancer of the breast or cervix in situ
  • Previously treated malignancy, if all treatment for that malignancy was completed at least 2 years prior to first dose of study treatment, and no current evidence of disease
  • Concurrent malignancy determined to be clinically stable and not requiring tumor directed treatment
  • Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) that is unstable or not controlled with treatment.
  • History of COVID-19 infection within 4 weeks prior to enrolment and/or have persistent, clinically significant pulmonary symptoms related to prior COVID-19 infection.
  • Active bleeding disorders.
  • Known hypersensitivity to the ingredients in zipalertinib or any drugs similar in structure or class. To platinum-containing drugs (ie, cisplatin, carboplatin), pemetrexed, or any known excipients of these drugs. b. Contraindications toning drugs (ie, cisplatin, carboplatin) or pemetrexed according to the respective local labels.
  • History of leptomeningeal disease and spinal cord compression.
  • Is unable or unwilling to take dexamethasone, folic acid, and/or vitamin B12 supplementation during treatment with pemetrexed.
  • Is pregnant or lactating or planning to become pregnant
  • The patient is, in the investigator's opinion, unable or unwilling to comply with the trial procedures.

Trial locations and contacts

110 sites in 22 countries.

110 sites in 22 countries

Japan14 sites

  • Kyushu Cancer Center

    Fukuoka, Hukuoka, 811-1395

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

  • Hirosaki University Hospital

    Hirosaki-Shi, Aomori, 036-8563

  • Kanazawa University Hospital

    Kanazawa, 920-8641

  • Cancer Institute Hospital of JFCR

    Koto, Tokyo, 135-8550

  • Saiseikai Kumamoto Hospital

    Kumamoto, Kumamoto, 861-4163

  • Aichi Cancer Center

    Nagoya, Aiti [Aichi], 464-8681

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Osaka City General Hospital

    Osaka, 534-0021

  • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

    Osaka, 541-8567

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakai-Shi, Osaka, 591-8555

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 160-8582

Other trials in Japan

Italy9 sites

  • Istituto Nazionale per la Ricerca sul Cancro

    Genova, Genoa, 16132

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

    Meldola, Forli-Cesena, 47014

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

    Meldola, Forlì-Cesena, 47014

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

    Milan, 20132

  • Azienda Ospedaliero - Universitaria di Modena

    Modena, 41224

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Azienda Unità Sanitaria Locale della Romagna

    Ravenna, 48121

  • IRCCS Istituto Nazionale Tumori Regina Elena

    Roma, 1444

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126

Other trials in Italy

Spain9 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006

  • Clínica Mi Tres Torres

    Barcelona, 08017

  • Hospital Quirónsalud Barcelona

    Barcelona, 08023

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario de Jaén

    Jaén, 23007

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Málaga - Hospital General

    Málaga, 29010

Other trials in Spain

United States8 sites

  • Gabrail Cancer and Research Center

    Canton, Ohio, 44718

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Southeast Henderson - Stephanie

    Henderson, Nevada, 89074

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II

    Las Vegas, Nevada, 89144

  • Comprehensive Cancer Centers of Nevada - Southwest

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada - Central Valley - Twain

    Las Vegas, Nevada, 89169

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89218

Other trials in United States

Turkey (Türkiye)8 sites

  • Medical Park Seyhan Hastanesi

    Adana, 01120

  • Hacettepe Üniversitesi Kanser Enstitüsü

    Ankara, 06010

  • Memorial Ankara Hastanesi

    Ankara, 6520

  • T.C. Saglik Bakanligi Ankara Bilkent Sehi?r Hastanesi?

    Çankaya, 06800

  • Trakya Üniversitesi Sa?l?k Ara?t?rma ve Uygulama Merkezi

    Edirne, 22130

  • Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi

    Etlik, 06010

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

Other trials in Turkey (Türkiye)

South Korea7 sites

  • Inha University Hospital

    Incheon, Incheon Gwang'yeogsi [Inch'on-Kwangyokshi], 22332

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnamdo [Kyongsangnam-do], 52727

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do

  • Korea University Anam Hospital

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 02841

  • Korea University Guro Hospital

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 08308

  • Catholic University of Korea Saint Vincent's Hospital

    Suwon, Gyeonggi-do, 16247

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

France6 sites

  • Hôpital Ambroise-Paré

    Boulogne-Billancourt, Île-de-France Region, 92100

  • Hôpital Côte De Nacre

    Caen, Basse-Normandie, 14033

  • Centre Hospitalier Universitaire Limoges

    Limoges, Limousin, 87042

  • Institut Curie

    Paris, Île-de-France Region, 75248

  • CH Cornouaille Quimper

    Quimper, 29000

  • Les Hôpitaux Universitaires de Strasbourg

    Strasbourg, Alsace, 67091

Other trials in France

Mexico6 sites

  • Investigacion Medica Galerias

    Aguascalientes, 20124

  • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

    Guadalajara, Jalisco, 44280

  • Actualidad Basada en la Investigación del Cáncer

    Guadalajara, Jalisco, 44680

  • Health Pharma Professional Research S.A. De C.V

    Mexico City, Mexico City, 3100

  • Clínica Integral Internacional de Oncología S de RL de CV

    Mirador, Puebla, 72530

  • FAICIC Clínical Research

    Veracruz, 91900

Other trials in Mexico

Brazil5 sites

  • Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60335-480

  • Clínica Neoplasias Litoral

    Itajaí, Santa Catatina, 88301

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-180

  • Hospital Mãe de Deus - Centro Integrado de Oncologia

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

Other trials in Brazil

Singapore5 sites

  • National Cancer Centre Singapore

    Singapore, 168583

  • Icon Cancer Centre - Mount Alvernia

    Singapore, 228510

  • Tan Tock Seng Hospital

    Singapore, 30433

  • Oncocare Cancer Centre

    Singapore, 308900

  • Icon Cancer Centre Mount Elizabeth

    Singapore, 574623

Other trials in Singapore

Belgium4 sites

  • Algemeen Ziekenhuis Maria Middelares

    Ghent, Oost-Vlaaderen, 9000

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, Flemish Brabant, 3000

  • Algemeen Ziekenhuis Delta - Campus Menen

    Menen, West Flanders, 8930

  • Algemeen Ziekenhuis Delta - Campus Rumbeke

    Rosières, West-Vlaanderen, 8800

Other trials in Belgium

Canada3 sites

  • William Osler Health System - Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • BC Cancer Vancouver

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Germany3 sites

  • Universitätsklinikum Gießen und Marburg - Gießen

    Giessen, Hesse, 35392

  • LMU Klinikum - Campus Innenstadt

    München, 80337

  • Universitätsklinikum Regensburg

    Regensburg, 93053

Other trials in Germany

Israel3 sites

  • Emek Medical Center

    Afula, 18101

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Assuta Hospital - Ramat HaHayal

    Tel Aviv, 69710

Other trials in Israel

Netherlands3 sites

  • Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, North Holland, 1066 CX

  • Vrije Universiteit Medisch Centrum

    Amsterdam, North Holland, 1081 HV

  • Radboud Universitair Medisch Centrum

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

Philippines3 sites

  • Asian Hospital and Medical Center

    City of Muntinlupa, 1780

  • The Medical City

    Pasig, National Capital Region, 1605

  • St. Luke's Medical Center - Quezon City

    Quezon City, Metropolitan Manila, 1112

Other trials in Philippines

Poland3 sites

  • Instytut MSF

    Lodz, Lódzkie, 90-302

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, Lublin Voivodeship, 20-954

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów

    Pozna?, Greater Poland Voivodeship, 60-569

Other trials in Poland

Thailand3 sites

  • Faculty of Medicine Siriraj Hospital

    Bang Phlat, Bangkok, 10700

  • Navamindradhiraj University - Faculty of Medicine Vajira Hospital

    Bangkok, Khet Dusit, 10300

  • King Chulalongkorn Memorial Hospital

    Pathum Wan, Bangkok, 10330

Other trials in Thailand

United Kingdom3 sites

  • Royal Free London NHS Foundation Trust

    London, England, NW3 2QG

  • Nottingham University Hospitals NHS Trust

    Nottingham, England, NG5 1PB

  • Torbay and South Devon NHS Foundation Trust

    Torquay, England, TQ2 7AA

Other trials in United Kingdom

Chile2 sites

  • Hospital Clínico Universidad de Chile

    Independencia, Santiago Metropolitan, 8380494

  • CentroEstudiosClinicosSAGA

    Santiago, Region de Santiago, 7500653

Other trials in Chile

Romania2 sites

  • Centrul de Oncologie Sf Nectarie

    Craiova, Dolj, 200746

  • Clinica SIGMedical

    Suceava, 720214

Other trials in Romania

Greece1 site

  • General Hospital for Thoracic Diseases Sotiria

    Athens, Attica, 11527

Other trials in Greece

About this study

Official title: Randomized, Controlled, Open-label, Phase 3, Global Multi - Center Trial to Assess the Efficacy and Safety of Zipalertinib Plus Chemotherapy Versus Chemotherapy Alone, in Patients With Previously Untreated, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

The purpose of this study is to evaluate the safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy compared to chemotherapy alone, in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations.

Read the detailed description

This study will evaluate the efficacy and safety of zipalertinib in combination with standard chemotherapy with pemetrexed and a platinum agent (either carboplatin or cisplatin) in patients with previously untreated, locally advanced or metastatic nonsquamous NSCLC harboring EGFR ex20ins mutations.

The study will be conducted in two parts:

  • Part A: Safety lead-in to determine the recommended dose of zipalertinib in combination with standard chemotherapy pemetrexed and a platinum agent (either carboplatin or cisplatin) to be studied in Part B of the study.
  • Part B: Randomized, controlled, open-label, multinational Phase 3 study to assess the efficacy and safety of zipalertinib in combination with standard chemotherapy with pemetrexed and a platinum agent (either carboplatin or cisplatin) compared to standard chemotherapy alone. Patients randomized to the chemotherapy-only treatment arm in Part B may receive treatment with zipalertinib as monotherapy after BICR-assessed progressive disease (PD) is documented (optional "crossover arm").

An independent data monitoring committee (IDMC) will be established to monitor interim safety Data.

A treatment cycle is defined as 21 days for both parts of the study.

Part A: Safety Lead-In The primary objective of Part A is to determine the recommended dose of zipalertinib administered in combination with pemetrexed and a platinum agent (either carboplatin or cisplatin) to be studied in the Phase 3 portion of this study.

Approximately 6-12 patients will receive zipalertinib administered at an initial dose of zipalertinib PO BID (Dose Level 1) in combination with pemetrexed and carboplatin or cisplatin on a 21-day cycle. Patients may continue to receive study treatment until documentation of progressive disease (PD) or until other withdrawal criteria are met, whichever comes first. Patients will be enrolled using a rolling-6 design,35 and the determination of the dose of zipalertinib to be used in Part B of the study will be informed by the incidence of dose-limiting toxicities (DLTs) observed during Cycle 1.

Part B: Phase 3 Enrollment into the Phase 3 portion of the study will begin following completion of Part A.

Approximately 260 patients will be randomized on a 1:1 basis to receive pemetrexed and a platinum agent (either carboplatin or cisplatin) with or without zipalertinib on a 21-day cycle.

Carboplatin or cisplatin will be administered for 4 cycles. Patients may continue to receive zipalertinib (experimental study arm) and pemetrexed (both study arms) until documentation of PD or until other withdrawal criteria are met, whichever comes first.

Being tested
TAS6417
Keywords
Exon 20 insertion mutation, NSCLC, phase 3, Lung disease, Carcinoma, Non-Small-Cell Lung, CLN-081, TAS6417, EGFR
Medical subject headings
Lung Diseases, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAS6417Drug

    Also called Zipalertinib, CLN-081

    oral tablets

Study groups in NCT05973773
Study groupRoleWhat they receive
Part A (Safety Lead in)ExperimentalPart A: Safety Lead-In Approximately 6-12 patients will receive zipalertinib administered at an initial dose of zipalertinib PO BID (Dose Level 1) in combination with pemetrexed and carboplatin or cisplatin on a 21-day cycle. Patients may continue to receive study treatment until documentation of progressive disease (PD) or until other withdrawal criteria are met, whichever comes first.
Receives: Drug: TAS6417
Part BExperimentalEnrollment into the Phase 3 portion of the study will begin following completion of Part A. Approximately 260 patients will be randomized on a 1:1 basis to receive pemetrexed and a platinum agent (either carboplatin or cisplatin) with or without zipalertinib on a 21-day cycle. Carboplatin or cisplatin will be administered for 4 cycles. Patients may continue to receive zipalertinib (experimental study arm) and pemetrexed (both study arms) until documentation of PD or until other withdrawal criteria are met, whichever comes first.
Receives: Drug: TAS6417

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A and B: The rate and severity of treatment emergent AEs

    Measured: approximately 5 years

  2. Part A and Part B: Progression-free survival (PFS) by blinded independent central review (BICR)

    Measured: approximately 5 years

  3. Part A: The rate and severity of DLTs according to the NCI-Common Terminology Criteria of Adverse Events (CTCAE) v5.0 during Cycle 1

    Measured: approximately 5 years

Secondary outcomes (11)

  1. Part A and Part B: Objective response rate (ORR)

    Measured: approximately 5 years

  2. Part A and Part B: Disease control rate (DCR)

    Measured: approximately 5 years

  3. Part A and Part B: Duration of response (DoR)

    Measured: approximately 5 years

  4. Part A and Part B: Intracranial (i) Overall Response Rate (iORR)

    Measured: approximately 5 years

  5. Part A and Part B: Intracranial duration of complete response (iDCR)

    Measured: approximately 5 years

  6. Part A and Part B: Intracranial duration of Response (iDoR)

    Measured: approximately 5 years

  7. Part B: Overall survival (OS)

    Measured: approximately 5 years

  8. Pharmacokinetic (PK) parameter

    Minimum observed concentration (Cmin)

    Measured: approximately 5 years

  9. European Quality of Life 5 Dimensions, 3 Level Version (EQ-5D-3L)

    The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. This scale is numbered from 0 to 100. The higher the score the better the outcome

    Measured: approximately 5 years

  10. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30

    The EORTC QLQ-C30 is a "core questionnaire" which incorporates a range of physical, emotional and social health developed to assess the quality of life of cancer patients. This scale is numbered from 30 to 130. The higher the score equates to better functioning.

    Measured: approximately 5 years

  11. Non-small Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ )

    The NSCLC- SAQ was developed to incorporate the patient's perspective into evaluation of clinical benefit in advanced non-small cell lung cancer trials.. Qualitative evidence supports 7 items covering 5 symptom concepts with the total score measuring overall severity of the following NSCLC symptoms: cough, pain, dyspnea, fatigue, and appetite. Lower scores indicate lower symptom severity.

    Measured: approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2023
  2. Study start18 Dec 2023
  3. Primary completion27 May 2027 (estimated)
  4. Study completion27 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05973773
Sponsor's protocol ID
TAS6417-301
Other IDs
2023-503575-21, 2023
Acronym
REZILIENT3
Status last verified
Oct 2026
First submitted
11 Jul 2023
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Heymach JV, Yu HA, Besse B, Cheng Y, Tan DS, Wei L, Wacheck V, Nishio M. REZILIENT3: randomized phase III study of first-line zipalertinib plus chemotherapy in patients with EGFR exon 20 insertion-mutated NSCLC. Future Oncol. 2025 Feb;21(5):549-556. doi: 10.1080/14796694.2025.2457294. Epub 2025 Feb 16.

    PubMed 39957151

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAS6417 in people with Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation, run by Taiho Oncology, Inc. at 110 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in Japan, Italy, Spain, United States, Turkey (Türkiye) and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A and B: The rate and severity of treatment emergent AEs (time frame: approximately 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05973773, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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