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Brief Title: REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)
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
Study ID: NCT05973773
Brief 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.
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Comprehensive Cancer Centers of Nevada - Henderson, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada - Horizon Ridge Henderson, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada - Southeast Henderson - Stephanie, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Southwest, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley - Twain, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas, Nevada, United States
Gabrail Cancer and Research Center, Canton, Ohio, United States
Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven, Flemish Brabant, Belgium
Algemeen Ziekenhuis Maria Middelares, Gent, Oost-Vlaaderen, Belgium
Algemeen Ziekenhuis Delta - Campus Rumbeke, Rosières, West-Vlaanderen, Belgium
William Osler Health System - Brampton Civic Hospital, Brampton, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Les Hôpitaux Universitaires de Strasbourg, Strasbourg cedex, Alsace, France
Hôpital Côte De Nacre, Caen cedex 9, Basse-Normandie, France
Institut Curie, Paris cedex, Ile-de-France, France
Centre Hospitalier Universitaire Limoges, Limoges, Limousin, France
Hôpital Haut-Lévêque, Pessac, Nouvelle-Aquitaine, France
Centre Hospitalier Le Mans, Le Mans cedex 9, Pays De La Loire, France
Hôpital Ambroise-Paré, Boulogne-Billancourt, Île-de-France, France
Universitätsklinikum Gießen und Marburg - Gießen, Gießen, Hessen, Germany
LMU Klinikum - Campus Innenstadt, München, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah University Hospital Ein Kerem, Jerusalem, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Assuta Hospital - Ramat HaHayal, Tel aviv, , Israel
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST, Meldola, Forlì-Cesena, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele, Milan, , Italy
Azienda Ospedaliero - Universitaria di Modena, Modena, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Azienda Unità Sanitaria Locale della Romagna, Ravenna, , Italy
Azienda Ospedaliera Universitaria Integrata Verona, Verona, , Italy
Aichi Cancer Center, Nagoya, Aiti [Aichi], Japan
Hirosaki University Hospital, Hirosaki-Shi, Aomori, Japan
Kyushu Cancer Center, Fukuoka-shi, Hukuoka, Japan
Kitasato University Hospital, Sagamihara, Kanagawa, Japan
Kanagawa Cardiovascular and Respiratory Center, Yokohama, Kanagawa, Japan
Saiseikai Kumamoto Hospital, Kumamoto-Shi, Kumamoto, Japan
Sendai Kousei Hospital, Sendai, Miyagi, Japan
Okayama University Hospital, Okayamashi, Okayama, Japan
Kansai Medical University Hospital, Hirakata, Osaka, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai-Shi, Osaka, Japan
Cancer Institute Hospital of JFCR, Koto, Tokyo, Japan
Keio University Hospital, Shinjuku-Ku, Tokyo, Japan
Kanazawa University Hospital, Kanazawa, , Japan
Osaka City General Hospital, Osaka, , Japan
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute, Osaka, , Japan
Catholic University of Korea Saint Vincent's Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of
Ajou University Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of
Gyeongsang National University Hospital, Jinju, Gyeongsangnamdo [Kyongsangnam-do], Korea, Republic of
Inha University Hospital, Incheon, Incheon Gwang'yeogsi [Inch'on-Kwangyokshi], Korea, Republic of
Korea University Anam Hospital, Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
Korea University Guro Hospital, Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
Radboud Universitair Medisch Centrum, Nijmegen, Gelderland, Netherlands
Vrije Universiteit Medisch Centrum, Amsterdam, Noord-Holland, Netherlands
St. Luke's Medical Center - Quezon City, Quezon City, Metropolitan Manila, Philippines
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Lublin, Lubelskie, Poland
Instytut MSF, Łódź, Lódzkie, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów, Pozna?, Wielkopolskie, Poland
Tan Tock Seng Hospital, Singapore, , Singapore
Complejo Hospitalario Universitario A Coruña, A Coruña, La Coruña, Spain
Clínica Mi Tres Torres, Barcelona, , Spain
Hospital Quirónsalud Barcelona, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Universitario de Jaén, Jaén, , Spain
MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Regional Universitario de Málaga - Hospital General, Málaga, , Spain
Torbay and South Devon NHS Foundation Trust, Torquay, England, Turkey
T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastanesi, Adana, , Turkey
Medical Park Seyhan Hastanesi, Adana, , Turkey
Memorial Ankara Hastanesi, Ankara, , Turkey
Trakya Üniversitesi Sa?l?k Ara?t?rma ve Uygulama Merkezi, Edirne, , Turkey
Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi, Etlik, , Turkey
Bagcilar Medipol Mega Universite Hastanesi, Istanbul, , Turkey
T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Istanbul, , Turkey
T.C. Saglik Bakanligi Ankara Bilkent Sehi?r Hastanesi?, Çankaya, , Turkey
Royal Free London NHS Foundation Trust, London, England, United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, England, United Kingdom