A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)
Фаза 2/3 – комбинирано изпитване
Заболявания:
Non-Small Cell Lung Cancer
Спонсор: Hoffmann-La Roche
Налично на:
БГ
Обобщение
This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by a blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assay.
Кой може да участва
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Measurable disease
* Adequate recovery from most recent systemic or local treatment for cancer
* Adequate organ function
* Life expectancy greater than or equal to (\>/=) 12 weeks
* For female participants of childbearing potential and male participants, willingness to use acceptable methods of contraception
Exclusion Criteria:
* Inability to swallow oral medication
* Women who are pregnant or lactating
* Symptomatic, untreated CNS metastases
* History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death
* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
* Known active or uncontrolled human immunodeficiency virus (HIV) infection
* Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
* Inability to comply with other requirements of the protocol
Места на провеждане
27
Argentina (1)
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires
Австралия (1)
Royal North Shore Hospital
St Leonards , New South Wales
Белгия (1)
UZ Brussel
Brussels
Бразилия (1)
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí , Rio Grande do Sul
Канада (1)
Cross Cancer Institute
Edmonton , Alberta
Chile (1)
Bradford Hill Centro de Investigaciones Clinicas
Recoleta
Китай (1)
Beijing Cancer Hospital
Beijing
Франция (1)
Institut Bergonie CLCC Bordeaux
Bordeaux
Германия (1)
Klinikum Chemnitz gGmbH
Chemnitz
Hong Kong (1)
Queen Mary Hospital
Hong Kong
Израел (1)
Soroka Medical Center
Beersheba
Италия (1)
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Naples , Campania
Япония (1)
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyō City
Mexico (1)
Hospital Angeles Tijuana
Tijuana , Estado de Baja California
New Zealand (1)
Auckland City Hospital
Auckland
Panama (1)
Hemato Oncología de Panamá Especializada
Panama City
Peru (1)
Hospital Nacional Edgardo Rebagliati Martins
Lima
Полша (1)
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gda?sk
Russia (1)
Moscow City Oncology Hospital #62
Moscovskaya Oblast , Moscow Oblast
Сърбия (1)
Clinical Center of Serbia
Belgrade
Сингапур (1)
National University Hospital
Singapore
Южна Корея (1)
National Cancer Center
Gyeonggi-do
Испания (1)
Insititut Catala D'Oncologia
L'Hospitalet de Llobregat , Barcelona
Taiwan (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Тайланд (1)
Faculty of Med. Siriraj Hosp.
Bangkok
Турция (1)
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology