A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)
Phase 2/3 – combined trial
Conditions:
Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
trial.available_in:
БГ
Overview
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.
Who can participate
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
Locations
27
Argentina (1)
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires
Australia (1)
Royal North Shore Hospital
St Leonards , New South Wales
Belgium (1)
UZ Brussel
Brussels
Brazil (1)
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí , Rio Grande do Sul
Canada (1)
Cross Cancer Institute
Edmonton , Alberta
Chile (1)
Bradford Hill Centro de Investigaciones Clinicas
Recoleta
China (1)
Beijing Cancer Hospital
Beijing
France (1)
Institut Bergonie CLCC Bordeaux
Bordeaux
Germany (1)
Klinikum Chemnitz gGmbH
Chemnitz
Hong Kong (1)
Queen Mary Hospital
Hong Kong
Israel (1)
Soroka Medical Center
Beersheba
Italy (1)
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Naples , Campania
Japan (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
Poland (1)
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gda?sk
Russia (1)
Moscow City Oncology Hospital #62
Moscovskaya Oblast , Moscow Oblast
Serbia (1)
Clinical Center of Serbia
Belgrade
Singapore (1)
National University Hospital
Singapore
South Korea (1)
National Cancer Center
Gyeonggi-do
Spain (1)
Insititut Catala D'Oncologia
L'Hospitalet de Llobregat , Barcelona
Taiwan (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Thailand (1)
Faculty of Med. Siriraj Hosp.
Bangkok
Turkey (1)
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology