Atezolizumab Plus Bevacizumab in First Line NSCLC Patients (NCT03836066) | Clinical Trial Compass
CompletedPhase 2
Atezolizumab Plus Bevacizumab in First Line NSCLC Patients
Spain41 participantsStarted 2019-05-15
Plain-language summary
This is a multi-center phase II clinical trial of atezolizumab in combination with bevacizumab as first line treatment for locally advanced or metastasic high-intermediate tumour mutation burden selected NSCLC patients. 102 patients will be enrolled in this trial to examine the efficacy of this combination measured by progression free survival according to response evaluation Criteria in solid tumours (RECIST) version 1.1.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, aged ≥ 18 years old
✓. ECOG performance status of 0 or 1.
✓. 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
✓. No prior treatment for Stage IIIB or IV non-squamous NSCLC.
✓. 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.
✓. Patients with a treated asymptomatic CNS metastasis are eligible, provided they meet all of the following criteria:
✓. Only supratentorial and cerebellar metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord).
✓. No ongoing requirement for corticosteroids as therapy for CNS disease.
Exclusion criteria
✕. Patients with a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene.
✕. Patients with an anaplastic lymphoma kinase (ALK) fusion oncogene.
✕. Patients with an STK-1 Ligand alteration.
What they're measuring
1
Efficacy of Atezolizumab in Combination With Bevacizumab - PFS
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
✕. Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.
✕. 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.