A phase II open-label study of Atezolizumab in combination with bevacizumab as first line treatment for locally advanced or metastatic high-intermediate tumour mutation burden (TMB) selected non-squamous non-small cell lung cancer (NSCLC) patients

Fundación GECP0 sites102 target enrollmentApril 11, 2019

Overview

No summary available.

Registry

who.int

Start Date

April 11, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Fundación GECP

•1\.Male or female, aged \= 18 years old
•2\.ECOG performance status of 0 or 1\.
•3\.Histologically or cytologically confirmed, Stage IIIB or IV non\-squamous NSCLC according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology
•4\.No prior treatment for Stage IIIB or IV non\-squamous NSCLC.
•5\.Patients who have received prior neo\-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo\-radiotherapy with curative intent for non\-metastatic disease must have experienced a treatment\-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemo\-radiotherapy.
•6\.Patients with a treated asymptomatic CNS metastasis are eligible, provided they meet all of the following criteria:
•a.Only supratentorial and cerebellar metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord).
•b.No ongoing requirement for corticosteroids as therapy for CNS disease.
•c.No stereotactic radiation within 7 days or whole\-brain radiation within 14 days prior to randomization.
•d.No evidence of interim progression between the completion of CNS\-directed therapy and the screening radiographic study.

•1\.Patients with a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene.
•2\.Patients with an anaplastic lymphoma kinase (ALK) fusion oncogene.
•3\.Patients with an STK\-1 Ligand alteration.
•4\.Patients with MDM2 amplification.
•5\.Patients with ROS1 translocations.
•6\.Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.
•7\.Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \> 2 weeks prior to randomization.
•8\.Leptomeningeal disease.
•9\.Uncontrolled tumour\-related pain.
•Patients requiring pain medication must be on a stable regimen at study entry.