Last updated 19 days ago
A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.
900 patients around the world
Available in Spain, Brazil, Argentina, Mexico
Adult patients with a histologically or cytologically documented metastatic NSCLC, with
tumors that lack activating EGFR, ALK, and ROS1 alterations are eligible for enrollment.
Patients will be randomized in a 1:1 ratio to receive treatment with volrustomig +
chemotherapy or pembrolizumab + chemotherapy. Tumor evaluation scans will be performed
until disease progression as efficacy assessment. All patients will be followed for
survival until the end of the study. An data monitoring committee (DMC) composed of
independent experts will be convened to confirm the safety and tolerability of the
proposed dose and schedule.
AstraZeneca
7Research sites
900Patients 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 documented squamous or non-squamous NSCLC.Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amenable to curative surgery or radiation.Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted first-line therapies.
- Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes are excluded.Spinal cord compression.Symptomatic brain metastases. Brain metastases may be treated or untreated, but participants must be asymptomatic and off steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.History of another primary malignancy except for:1. Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.3. Adequately treated carcinoma in situ without evidence of disease.As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.
Sites
Centro Médico Privado CEMAIC - Córdoba
Recruiting
DIABAID – Instituto de asistencia integral en diabetes y patologías crónicas, CABA, Buenos Aires
Recruiting
Instituto Médico Platense SA - La Plata
Recruiting
Consultorios Integrados Rosario (CIR)
Recruiting
Centro Gutman
Recruiting
Sanatorio Allende (Nueva Córdoba)
Recruiting
Hospital Italiano de La Plata
Recruiting
StudyeVOLVE-Lung02
SponsorAstraZeneca
Conditions
Non-small cell lung carcinomaLung cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05984277
