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

Status: Recruiting
Location: See all (130) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

‣ 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.

• b. 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.

Locations
United States
Nevada
Comprehensive Cancer Centers of Nevada - Henderson
RECRUITING
Henderson
Comprehensive Cancer Centers of Nevada - Horizon Ridge Henderson
RECRUITING
Henderson
Comprehensive Cancer Centers of Nevada - Southeast Henderson - Stephanie
RECRUITING
Henderson
Comprehensive Cancer Centers of Nevada - Central Valley - Twain
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Southwest
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II
RECRUITING
Las Vegas
Ohio
Gabrail Cancer and Research Center
RECRUITING
Canton
The Toledo Clinic Cancer Center
WITHDRAWN
Toledo
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Belgium
Algemeen Ziekenhuis Maria Middelares
RECRUITING
Ghent
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
RECRUITING
Leuven
Algemeen Ziekenhuis Delta - Campus Menen
RECRUITING
Menen
Algemeen Ziekenhuis Delta - Campus Rumbeke
RECRUITING
Rosières
Brazil
Centro Regional Integrado de Oncologia
RECRUITING
Fortaleza
Clínica Neoplasias Litoral
RECRUITING
Itajaí
Hospital Amaral Carvalho
RECRUITING
Jaú
Hospital Mãe de Deus - Centro Integrado de Oncologia
RECRUITING
Porto Alegre
Hospital São Lucas da PUCRS
RECRUITING
Porto Alegre
Bulgaria
Multi-profile Hospital for Active Treatment Uni Hospital
RECRUITING
Panagyurishte
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL
RECRUITING
Sofia
Canada
William Osler Health System - Brampton Civic Hospital
RECRUITING
Brampton
Princess Margaret Cancer Centre
RECRUITING
Toronto
BC Cancer Vancouver
RECRUITING
Vancouver
Chile
Hospital Clínico Universidad de Chile
RECRUITING
Independencia
Instituto Oncológico Fundación Arturo López Pérez
RECRUITING
Providencia
CentroEstudiosClinicosSAGA
RECRUITING
Santiago
France
Hôpital Ambroise-Paré
RECRUITING
Boulogne-billancourt
Hôpital Côte De Nacre
RECRUITING
Caen
Centre Hospitalier Le Mans
RECRUITING
Le Mans
Centre Hospitalier Universitaire Limoges
RECRUITING
Limoges
Institut Curie
RECRUITING
Paris
Hôpital Haut-Lévêque
RECRUITING
Pessac
CH Cornouaille Quimper
RECRUITING
Quimper
Les Hôpitaux Universitaires de Strasbourg
RECRUITING
Strasbourg
Gustave Roussy
RECRUITING
Villejuif
Germany
Universitätsklinikum Gießen und Marburg - Gießen
RECRUITING
Giessen
Asklepios Klinik Altona
RECRUITING
Hamburg
LMU Klinikum - Campus Innenstadt
RECRUITING
München
Universitätsklinikum Regensburg
RECRUITING
Regensburg
Greece
General Hospital for Thoracic Diseases Sotiria
RECRUITING
Athens
University General Hospital of Larissa
RECRUITING
Larissa
University General Hospital of Patras
RECRUITING
Patra
Metropolitan General
RECRUITING
Piraeus
Metropolitan Hospital
RECRUITING
Piraeus
BioClinic Thessaloniki
RECRUITING
Thessaloniki
Israel
Emek Medical Center
RECRUITING
Afula
Hadassah University Hospital Ein Kerem
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Assuta Hospital - Ramat HaHayal
RECRUITING
Tel Aviv
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Istituto Nazionale per la Ricerca sul Cancro
RECRUITING
Genova
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST
RECRUITING
Meldola
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
RECRUITING
Milan
Azienda Ospedaliero - Universitaria di Modena
RECRUITING
Modena
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Azienda Unità Sanitaria Locale della Romagna
RECRUITING
Ravenna
IRCCS Istituto Nazionale Tumori Regina Elena
RECRUITING
Roma
Azienda Ospedaliera Universitaria Integrata Verona
RECRUITING
Verona
Japan
Kyushu Cancer Center
RECRUITING
Fukuoka
Kansai Medical University Hospital
RECRUITING
Hirakata
Hirosaki University Hospital
RECRUITING
Hirosaki-shi
Kanazawa University Hospital
RECRUITING
Kanazawa
Cancer Institute Hospital of JFCR
RECRUITING
Koto
Saiseikai Kumamoto Hospital
RECRUITING
Kumamoto
Aichi Cancer Center
RECRUITING
Nagoya
Okayama University Hospital
RECRUITING
Okayama
Osaka City General Hospital
RECRUITING
Osaka
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
RECRUITING
Osaka
Kitasato University Hospital
RECRUITING
Sagamihara
National Hospital Organization Kinki-Chuo Chest Medical Center
RECRUITING
Sakai-shi
Sendai Kousei Hospital
RECRUITING
Sendai
Keio University Hospital
RECRUITING
Shinjuku-ku
Kanagawa Cardiovascular and Respiratory Center
RECRUITING
Yokohama
Mexico
Investigacion Medica Galerias
RECRUITING
Aguascalientes
Actualidad Basada en la Investigación del Cáncer
RECRUITING
Guadalajara
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
RECRUITING
Guadalajara
Health Pharma Professional Research S.A. De C.V
RECRUITING
Mexico City
Clínica Integral Internacional de Oncología S de RL de CV
RECRUITING
Mirador
FAICIC Clínical Research
RECRUITING
Veracruz
Netherlands
Antoni Van Leeuwenhoek Ziekenhuis
RECRUITING
Amsterdam
Vrije Universiteit Medisch Centrum
RECRUITING
Amsterdam
Radboud Universitair Medisch Centrum
RECRUITING
Nijmegen
Philippines
Asian Hospital and Medical Center
RECRUITING
City Of Muntinlupa
The Medical City
RECRUITING
Pasig
St. Luke's Medical Center - Quezon City
RECRUITING
Quezon City
Poland
Instytut MSF
RECRUITING
Lodz
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
RECRUITING
Lublin
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
RECRUITING
Pozna?
Republic of Korea
Inha University Hospital
RECRUITING
Incheon
Gyeongsang National University Hospital
RECRUITING
Jinju
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Korea University Anam Hospital
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Catholic University of Korea Saint Vincent's Hospital
RECRUITING
Suwon
Romania
Medisprof
RECRUITING
Cluj-napoca
Centrul de Oncologie Sf Nectarie
RECRUITING
Craiova
Clinica SIGMedical
RECRUITING
Suceava
Oncocenter - Oncologie Clinica
RECRUITING
Timișoara
Singapore
Icon Cancer Centre - Mount Alvernia
RECRUITING
Singapore
Icon Cancer Centre Mount Elizabeth
RECRUITING
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
Oncocare Cancer Centre
RECRUITING
Singapore
Tan Tock Seng Hospital
NOT_YET_RECRUITING
Singapore
Spain
Complejo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Clínica Mi Tres Torres
RECRUITING
Barcelona
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Quirónsalud Barcelona
RECRUITING
Barcelona
Hospital Universitario de Jaén
RECRUITING
Jaén
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
MD Anderson Cancer Center Madrid
RECRUITING
Madrid
Hospital Regional Universitario de Málaga - Hospital General
RECRUITING
Málaga
Thailand
Faculty of Medicine Siriraj Hospital
RECRUITING
Bang Phlat
Navamindradhiraj University - Faculty of Medicine Vajira Hospital
RECRUITING
Bangkok
King Chulalongkorn Memorial Hospital
RECRUITING
Pathum Wan
Turkey
Medical Park Seyhan Hastanesi
RECRUITING
Adana
T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastanesi
RECRUITING
Adana
Hacettepe Üniversitesi Kanser Enstitüsü
RECRUITING
Ankara
Memorial Ankara Hastanesi
RECRUITING
Ankara
T.C. Saglik Bakanligi Ankara Bilkent Sehi?r Hastanesi?
RECRUITING
Çankaya
Trakya Üniversitesi Sa?l?k Ara?t?rma ve Uygulama Merkezi
RECRUITING
Edirne
Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi
RECRUITING
Etlik
Bagcilar Medipol Mega Universite Hastanesi
RECRUITING
Istanbul
T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
RECRUITING
Istanbul
United Kingdom
Royal Free London NHS Foundation Trust
RECRUITING
London
Nottingham University Hospitals NHS Trust
RECRUITING
Nottingham
Torbay and South Devon NHS Foundation Trust
RECRUITING
Torquay
Contact Information
Primary
Taiho Oncology, INC
medicalinformation@taihooncology.com
+1 844-878-2446
Time Frame
Start Date: 2023-06-30
Estimated Completion Date: 2026-08-24
Participants
Target number of participants: 272
Treatments
Experimental: Part A (Safety Lead in)
Part 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.
Experimental: Part B
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.
Sponsors
Leads: Taiho Oncology, Inc.

This content was sourced from clinicaltrials.gov

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