Last updated 48 days ago
A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer
340 patients around the world
Available in Argentina
GlaxoSmithKline
8Research sites
340Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or non squamous)No prior systemic therapy for their locally advanced or metastatic NSCLCProvides a fresh tumor tissue sample or recent archival sample collected within 2 years prior to screeningPD-L1-high (TC/TPS ≥ 50%) tumorMeasurable disease based on RECIST 1.1, as determined by the investigatorEastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1Adequate baseline organ functionFemale participants of childbearing potential must use adequate contraception
- Presence of Epidermal growth factor receptor (EGFR) mutations, Anaplastic lymphoma kinase (ALK) translocations, or other known genomic aberrations or oncogenic driver mutations for which a locally approved therapy is available. All participants with non squamous histology must have been tested for EGFR mutation and ALK translocation statusHad major surgery within 4 weeks or lung radiation of >30 grays (Gy) therapy within 6 months prior to the first dose of study interventionReceived prior therapy with any immune checkpoint inhibitorsNever smoker, defined as smoking <100 tobacco cigarettes in a lifetimeHas an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years (clinical exceptions apply as per protocol)Symptomatic, untreated, or actively progressing brain metastases and/or leptomeningeal disease (regardless of symptomatology, treatment status, or stability)Autoimmune disease or syndrome that required systemic treatment within the past 2 yearsReceiving any form of immunosuppressive medicationReceived any live vaccine ≤ 30 days prior to first dose of study interventionAny history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitisHistory or evidence of cardiac abnormalities ≤6 months prior to enrollmentCurrent unstable liver or biliary diseaseSevere infection within 4 weeks prior to randomizationPositive for tuberculosis, human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis CHas advanced, symptomatic, or visceral spread and is considered to be at imminent risk of life-threatening complications (including, but not limited to, massive uncontrolled effusions [e.g., pleural, pericardial, peritoneal])Is currently participating in or has participated in a study of an investigational therapy within 4 weeks prior to the first dose of study interventionHas a history of allogeneic tissue/stem cell transplant or solid organ transplant
Sites
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
Recruiting
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Centro Médico Fleischer
Recruiting
Dra. Susana Vighi - Centro de Anatomía Patológica
Recruiting
Fundación Médica de Río Negro y Neuquén - Cipolletti
Recruiting
Fundación Respirar
Recruiting
Laboratorio Haleon Argentina
Recruiting
SponsorGlaxoSmithKline
Study typeInterventional
Conditions
Non-small cell lung carcinomaLung cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05565378
