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

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Taiho Oncology, Inc. (industry)

Phase: 3

Start date: June 30, 2023

Planned enrollment: 272

Last updated in HealthScout: Nov 2024

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Investigational Drug AI Analysis

chevron Show for: TAS6417 (CLN-081, zipalertinib)

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Trial ID: NCT05973773
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More trial details at ClinicalTrials.gov More info

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Goal: The trial's goal is to evaluate and compare the safety and efficacy of the investigational drug zipalertinib, combined with standard first-line chemotherapy, against chemotherapy alone in patients with advanced NSCLC who have EGFR exon 20 insertion mutations.

Patients: This trial involves patients aged 18 years or older, diagnosed with locally advanced or metastatic nonsquamous non-small cell lung cancer with confirmed EGFR exon 20 insertion mutations. Eligible participants have not received prior systemic treatment for advanced or metastatic disease, and those with stable CNS metastases may participate.

Design: The study follows a randomized, controlled, open-label, multinational Phase 3 design comprised of two main parts. Part A is a safety lead-in to establish the safe dose for zipalertinib. Part B is a 1:1 randomized, open-label comparison between the zipalertinib plus chemotherapy regimen and chemotherapy alone.

Treatments: The study investigates zipalertinib (TAS6417), an oral, irreversible tyrosine kinase inhibitor targeting EGFR exon 20 insertion mutations, distinguished by its selective action on mutant EGFR. Previous trials have shown it offers a partial response rate of 38.4% in pretreated patients, with a median progression-free survival of 10 months and a favorable safety profile. Standard chemotherapy protocols involve pemetrexed and a platinum agent (carboplatin or cisplatin) administered over a 21-day cycle.

Outcomes: The primary outcomes comprise the rate and severity of treatment-emergent adverse events, and progression-free survival (PFS). Secondary outcomes include overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DoR), intracranial responses, quality of life assessments, and pharmacokinetic parameters.

Burden on patient: The overall burden on patients is moderate. Participation involves regular 21-day cycles of chemotherapy with zipalertinib in the experimental arm. Patients will undergo scans and blood draws consistent with standard oncology practice but may be more frequent due to the trial's requirements for pharmacokinetics and close monitoring. Frequent travel for treatment administrations and monitoring visits may increase the burden compared to oral regimen studies.

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Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

No email / No phone

Status: Recruiting

Algemeen Ziekenhuis Maria Middelares

Gent, Oost-Vlaaderen, 9000, Belgium

No email / No phone

Status: Recruiting

Algemeen Ziekenhuis Delta - Campus Menen

Menen, West Flanders, 8930, Belgium

No email / No phone

Status: Recruiting

Algemeen Ziekenhuis Delta - Campus Rumbeke

Rosières, West-Vlaanderen, 8800, Belgium

No email / No phone

Status: Recruiting

Centro Regional Integrado de Oncologia

Fortaleza, Ceará, 60335-480, Brazil

No email / No phone

Status: Recruiting

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande Do Sul, 90610-000, Brazil

No email / No phone

Status: Recruiting

Clínica Neoplasias Litoral

Itajaí, Santa Catatina, 88301, Brazil

No email / No phone

Status: Recruiting

Hospital Amaral Carvalho

Jaú, São Paulo, 17210-180, Brazil

No email / No phone

Status: Recruiting

Multi-profile Hospital for Active Treatment Uni Hospital

Panagyurishte, Pazardzhik, 1527, Bulgaria

No email / No phone

Status: Recruiting

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL

Sofia, 4500, Bulgaria

No email / No phone

Status: Recruiting

William Osler Health System - Brampton Civic Hospital

Brampton, Ontario, L6R 3J7, Canada

No email / No phone

Status: Recruiting

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

No email / No phone

Status: Not yet recruiting

Les Hôpitaux Universitaires de Strasbourg

Strasbourg cedex, Alsace, 67091, France

No email / No phone

Status: Recruiting

Hôpital Côte De Nacre

Caen cedex 9, Basse-Normandie, 14033, France

No email / No phone

Status: Recruiting

Institut Curie

Paris cedex, Ile-de-France, 75248, France

No email / No phone

Status: Recruiting

Hôpital Ambroise-Paré

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

No email / No phone

Status: Recruiting

Centre Hospitalier Universitaire Limoges

Limoges, Limousin, 87042, France

No email / No phone

Status: Recruiting

Hôpital Haut-Lévêque

Pessac, Nouvelle-Aquitaine, 33604, France

No email / No phone

Status: Recruiting

Centre Hospitalier Le Mans

Le Mans cedex 9, Pays De La Loire, 72037, France

No email / No phone

Status: Recruiting

Gustave Roussy

Villejuif, Val-de-Marne, 94805, France

No email / No phone

Status: Recruiting

Asklepios Klinik Altona

Hamburg, Hamburg (Hansestadt), 22763, Germany

No email / No phone

Status: Recruiting

Universitätsklinikum Gießen und Marburg - Gießen

Gießen, Hessen, 35392, Germany

No email / No phone

Status: Recruiting

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

No email / No phone

Status: Recruiting

LMU Klinikum - Campus Innenstadt

München, 80337, Germany

No email / No phone

Status: Not yet recruiting

Metropolitan General

Piraeus, Attica, 18547, Greece

No email / No phone

Status: Recruiting

General Hospital for Thoracic Diseases Sotiria

Athens, Attica, 11527, Greece

No email / No phone

Status: Recruiting

University General Hospital of Patras

Patra, Peloponnese, 26504, Greece

No email / No phone

Status: Recruiting

Metropolitan Hospital

Peiraias, Pireas, 185 47, Greece

No email / No phone

Status: Recruiting

University General Hospital of Larissa

Larissa, Thessaly, 41110, Greece

No email / No phone

Status: Recruiting

BioClinic Thessaloniki

Thessaloniki, 54622, Greece

No email / No phone

Status: Recruiting

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

No email / No phone

Status: Recruiting

Emek Medical Center

Afula, 18101, Israel

No email / No phone

Status: Recruiting

Hadassah University Hospital Ein Kerem

Jerusalem, 9112001, Israel

No email / No phone

Status: Recruiting

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

No email / No phone

Status: Recruiting

Assuta Hospital - Ramat HaHayal

Tel aviv, 69710, Israel

No email / No phone

Status: Recruiting

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

Meldola, Forlì-Cesena, 47014, Italy

No email / No phone

Status: Recruiting

Azienda Ospedaliero - Universitaria di Modena

Modena, 41224, Italy

No email / No phone

Status: Recruiting

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

No email / No phone

Status: Recruiting

Azienda Unità Sanitaria Locale della Romagna

Ravenna, 48121, Italy

No email / No phone

Status: Recruiting

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

No email / No phone

Status: Recruiting

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

Milan, 20132, Italy

No email / No phone

Status: Recruiting

Aichi Cancer Center

Nagoya, Aiti [Aichi], 464-8681, Japan

No email / No phone

Status: Recruiting

Hirosaki University Hospital

Hirosaki-Shi, Aomori, 036-8563, Japan

No email / No phone

Status: Recruiting

Kyushu Cancer Center

Fukuoka-shi, Hukuoka, 811-1395, Japan

No email / No phone

Status: Recruiting

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, 236-0051, Japan

No email / No phone

Status: Recruiting

Kitasato University Hospital

Sagamihara, Kanagawa, 252-0375, Japan

No email / No phone

Status: Recruiting

Saiseikai Kumamoto Hospital

Kumamoto-Shi, Kumamoto, 861-4163, Japan

No email / No phone

Status: Recruiting

Sendai Kousei Hospital

Sendai, Miyagi, 980-0873, Japan

No email / No phone

Status: Recruiting

Okayama University Hospital

Okayamashi, Okayama, 700-8558, Japan

No email / No phone

Status: Recruiting

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai-Shi, Osaka, 591-8555, Japan

No email / No phone

Status: Recruiting

Kansai Medical University Hospital

Hirakata, Osaka, 573-1191, Japan

No email / No phone

Status: Recruiting

Keio University Hospital

Shinjuku-Ku, Tokyo, 160-8582, Japan

No email / No phone

Status: Not yet recruiting

Cancer Institute Hospital of JFCR

Koto, Tokyo, 135-8550, Japan

No email / No phone

Status: Recruiting

Osaka City General Hospital

Osaka, 534-0021, Japan

No email / No phone

Status: Recruiting

Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

Osaka, 541-8567, Japan

No email / No phone

Status: Recruiting

Kanazawa University Hospital

Kanazawa, 920-8641, Japan

No email / No phone

Status: Recruiting

Catholic University of Korea Saint Vincent's Hospital

Suwon-si, Gyeonggi-do, 16247, Korea, Republic of

No email / No phone

Status: Not yet recruiting

Ajou University Hospital

Suwon-si, Gyeonggi-do, 16499, Korea, Republic of

No email / No phone

Status: Not yet recruiting

Gyeongsang National University Hospital

Jinju, Gyeongsangnamdo [Kyongsangnam-do], 52727, Korea, Republic of

No email / No phone

Status: Not yet recruiting

Inha University Hospital

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

No email / No phone

Status: Not yet recruiting

Korea University Anam Hospital

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 02841, Korea, Republic of

No email / No phone

Status: Not yet recruiting

Korea University Guro Hospital

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 08308, Korea, Republic of

No email / No phone

Status: Not yet recruiting

Clínica Integral Internacional de Oncología S de RL de CV

Mirador, Puebla, 72530, Mexico

No email / No phone

Status: Recruiting

FAICIC Clínical Research

Veracruz, 91900, Mexico

No email / No phone

Status: Recruiting

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, 6525 GA, Netherlands

No email / No phone

Status: Recruiting

Vrije Universiteit Medisch Centrum

Amsterdam, Noord-Holland, 1081 HV, Netherlands

No email / No phone

Status: Recruiting

St. Luke's Medical Center - Quezon City

Quezon City, Metropolitan Manila, 1112, Philippines

No email / No phone

Status: Not yet recruiting

Asian Hospital and Medical Center

Muntinlupa, 1780, Philippines

No email / No phone

Status: Recruiting

Instytut MSF

Łódź, Lódzkie, 90-302, Poland

No email / No phone

Status: Not yet recruiting

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, Lubelskie, 20-954, Poland

No email / No phone

Status: Not yet recruiting

Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów

Pozna?, Wielkopolskie, 60-569, Poland

No email / No phone

Status: Not yet recruiting

Medisprof

Cluj-Napoca, Cluj, 400641, Romania

No email / No phone

Status: Recruiting

Centrul de Oncologie Sf Nectarie

Craiova, Dolj, 200746, Romania

No email / No phone

Status: Recruiting

Oncocenter - Oncologie Clinica

Timişoara, Timis, 300166, Romania

No email / No phone

Status: Recruiting

Clinica SIGMedical

Suceava, 720214, Romania

No email / No phone

Status: Recruiting

Tan Tock Seng Hospital

Singapore, 30433, Singapore

No email / No phone

Status: Not yet recruiting

Icon Cancer Centre - Mount Alvernia

Singapore, 228510, Singapore

No email / No phone

Status: Recruiting

Oncocare Cancer Centre

Singapore, 308900, Singapore

No email / No phone

Status: Recruiting

Icon Cancer Centre Mount Elizabeth

Singapore, 574623, Singapore

No email / No phone

Status: Recruiting

Complejo Hospitalario Universitario A Coruña

A Coruña, La Coruña, 15006, Spain

No email / No phone

Status: Not yet recruiting

Hospital Universitario La Paz

Madrid, 28046, Spain

No email / No phone

Status: Recruiting

Hospital Regional Universitario de Málaga - Hospital General

Málaga, 29010, Spain

No email / No phone

Status: Not yet recruiting

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

No email / No phone

Status: Not yet recruiting

Hospital Universitario de Jaén

Jaén, 23007, Spain

No email / No phone

Status: Recruiting

MD Anderson Cancer Center Madrid

Madrid, 28033, Spain

No email / No phone

Status: Not yet recruiting

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

No email / No phone

Status: Not yet recruiting

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

No email / No phone

Status: Not yet recruiting

Clínica Mi Tres Torres

Barcelona, 08017, Spain

No email / No phone

Status: Recruiting

Hospital Quirónsalud Barcelona

Barcelona, 08023, Spain

No email / No phone

Status: Recruiting

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

No email / No phone

Status: Recruiting

Faculty of Medicine Siriraj Hospital

Bang Phlat, Bangkok, 10700, Thailand

No email / No phone

Status: Recruiting

Navamindradhiraj University - Faculty of Medicine Vajira Hospital

Krung Thep Maha Nakhon, Khet Dusit, 10300, Thailand

No email / No phone

Status: Recruiting

Memorial Ankara Hastanesi

Ankara, 6520, Turkey

No email / No phone

Status: Recruiting

T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastanesi

Adana, 01060, Turkey

No email / No phone

Status: Not yet recruiting

Medical Park Seyhan Hastanesi

Adana, 01120, Turkey

No email / No phone

Status: Recruiting

Hacettepe Üniversitesi Kanser Enstitüsü

Ankara, 06010, Turkey

No email / No phone

Status: Not yet recruiting

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

Edirne, 22130, Turkey

No email / No phone

Status: Not yet recruiting

Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi

Etlik, 06010, Turkey

No email / No phone

Status: Not yet recruiting

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, 34214, Turkey

No email / No phone

Status: Recruiting

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

Istanbul, 34722, Turkey

No email / No phone

Status: Recruiting

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

Çankaya, 06800, Turkey

No email / No phone

Status: Not yet recruiting

Nottingham University Hospitals NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

No email / No phone

Status: Recruiting

Torbay and South Devon NHS Foundation Trust

Torquay, England, TQ2 7AA, United Kingdom

No email / No phone

Status: Not yet recruiting

Royal Free London NHS Foundation Trust

London, England, NW3 2QG, United Kingdom

No email / No phone

Status: Recruiting

Comprehensive Cancer Centers of Nevada - Horizon Ridge Henderson

Henderson, Nevada, 89052, United States

No email / No phone

Status: Recruiting

Comprehensive Cancer Centers of Nevada - Southeast Henderson - Stephanie

Henderson, Nevada, 89074, United States

No email / No phone

Status: Recruiting

Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II

Las Vegas, Nevada, 89144, United States

No email / No phone

Status: Recruiting

Comprehensive Cancer Centers of Nevada - Central Valley - Twain

Las Vegas, Nevada, 89169, United States

No email / No phone

Status: Recruiting

Comprehensive Cancer Centers of Nevada - Southwest

Las Vegas, Nevada, 89148, United States

No email / No phone

Status: Recruiting

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, 89218, United States

No email / No phone

Status: Recruiting

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, 89052, United States

No email / No phone

Status: Recruiting

Gabrail Cancer and Research Center

Canton, Ohio, 44718, United States

No email / No phone

Status: Recruiting

The Toledo Clinic Cancer Center

Toledo, Ohio, 43623, United States

No email / No phone

Status: Withdrawn

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

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