A Phase II Study of Atezolizumab in Combination With Bevacizumab, Carboplatin or Cisplatin, and P… (NCT04147351) | Clinical Trial Compass
CompletedPhase 2
A Phase II Study of Atezolizumab in Combination With Bevacizumab, Carboplatin or Cisplatin, and Pemetrexed for EGFR-mutant Metastatic Non-small Cell Lung Cancer Patients After Failure of EGFR Tyrosine Kinase Inhibitors.
Taiwan22 participantsStarted 2020-04-10
Plain-language summary
using Atezolizumab, a PD-L1 inhibitor, in combination with bevacizumab, platinum and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors.
Who can participate
Age range20 Years
SexALL
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Inclusion Criteria:
* Stage IIIB\~IV NSCLC with known EGFR activating mutation not amenable to curative surgery or radiotherapy. EGFR activating mutations include exon19 deletion, L858R, G719X, L861Q, or S768I.
* Radiological documentation of disease progression following one or more lines of EGFR TKI treatment but have not received palliative chemotherapy.
* Patients must receive tumor EGFR genotyping in re-biopsied FFPE tumor samples.
* At least 20 years of age.
* World Health Organisation (WHO) performance status 0-2 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks
* At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥ 15mm) with computed tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements.
* Normal bone marrow and organ function as defined below:
* Marrow: Hemoglobin ≥10gm/dL, absolute granulocyte count (AGC) ≥1500/mm3 platelets ≥100,000/mm3, absolute lymphocyte count ≥1000/mm3.
* Hepatic: Serum/plasma total bilirubin ≤1.5 x upper limit of normal (ULN) with the exception of \<2.9 mg/dL for patients with Gilbert's disease, ALT (SGPT) and AST (SGOT) ≤2.5 x ULN.
* Renal: Serum/plasma creatinine (sCr) ≤1.5 x upper limit of normal, or creatinine clearance (Ccr) ≥45 mL/min.
* For female patients of …