The aim of the trial is to assess efficacy and safety of the treatment with durvalumab in PS 2 patients with treatment-naïve, locally advanced or metastatic, PD-L1 positive NSCLC who are considered unsuitable for combination platinum-containing therapy.
Name: Durvalumab
Description: Durvalumab 1500mg q4W until progression or unacceptable toxicityType: DrugDurvalumab
Description: OS at 6 months is defined as being alive at 6 months after registration.
Measure: Overall survival (OS) at 6 months Time: At 6 months after registrationDescription: OR is defined as any complete response (CR) or partial response (PR) according to RECIST 1.1 criteria achieved during trial treatment.
Measure: Objective response (OR) according to RECIST 1.1 Time: At trial treatment discontinuation or the latest 5 years after last patient discontinued trial treatmentDescription: iOR is defined as any complete response (CR/iCR) or partial response (PR/iPR) according to RECIST1.1 or iRECIST criteria achieved during trial treatment.
Measure: Objective response according to iRECIST (iOR) Time: At trial treatment discontinuation or the latest 5 years after last patient discontinued trial treatmentDescription: DoR is defined as the time from the first documentation of OR until disease progression according to RECIST 1.1 criteria or death due to disease progression, whichever occurs first.
Measure: Duration of response (DoR) according to RECIST 1.1 Time: At disease progression according to RECIST 1.1 criteria or death due to disease progression or the latest 5 years after last patient discontinued trial treatmentDescription: iDoR is defined as the time from the first documentation of iOR until disease progression according to iRECIST criteria (iPD) or death due to disease progression.
Measure: Duration of response according to iRECIST (iDoR) Time: At disease progression according to iRECIST criteria (iPD) or death due to disease progression or the latest 5 years after last patient discontinued trial treatmentDescription: PFS is defined as the time from registration until disease progression according to RECIST v1.1 criteria or death due to any cause, whichever occurs first.
Measure: Progression-free survival (PFS) according to RECIST 1.1 Time: At disease progression according to RECIST v1.1 criteria or death due to any cause or the latest 5 years after last patient discontinued trial treatmentDescription: iPFS is defined as the time from registration until disease progression according to iRECIST criteria (iPD) or death due to any reason, whichever occurs first. iPD is defined as the time point of first iUPD without subsequent iSD, iPR or iCR before trial treatment discontinuation. Patients not experiencing an event at the time of the analysis, as well as patients starting a subsequent anticancer treatment in the absence of an event, will be censored at the date of their last available tumor assessment showing no evidence of iPD before starting a subsequent anticancer treatment, if any.
Measure: Progression-free survival according to iRECIST (iPFS) Time: At disease progression according to iRECIST criteria (iPD) or death due to any reason or the latest 5 years after last patient discontinued trial treatmentDescription: OS is defined as the time from registration until death due to any cause
Measure: Overall survival (OS) Time: At death of the patient or the latest 5 years after last patient discontinued trial treatmentDescription: All AEs will be assessed according to NCI CTCAE v5.0
Measure: Adverse events (AEs) Time: From registration until 28 days after last trial treatment doseDescription: QoL is measured by the Questionnaire Core 30 (QLQ-C30) including the complementary Lung Cancer Module (QLQ-LC13)
Measure: Quality of life (QoL): Core 30 (QLQ-C30) Time: From registration until trial treatment discontinuation or the latest 1 year after registrationDescription: Screening instrument (G8)
Measure: Geriatric assessment (GA) - Screening instrument (G8) Time: At baselineDescription: Assessment with IADL
Measure: Geriatric assessment (GA) - Assessment with IADL Time: At baselineDescription: Comorbidities assessment with CCI
Measure: Geriatric assessment (GA) Time: At baselineSingle Group Assignment
There is one SNP
Cytology could be accepted if histology is not possible - PD-L1 expression of ≥ 25% of the tumor cells by local testing (Ventana SP142 excluded) - No sensitizing EGFR mutation (L858R or exon 19 deletions), ALK fusion oncogene or rearrangements of the ROS1 gene detected - Patient unsuitable for platinum-containing combination chemotherapy according to investigator or due to patient preference - WHO PS of 2 - Age ≥ 18 years - Baseline QoL forms and GA questionnaires have been completed - Bone marrow function: hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L - Hepatic function: bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease ≤ 3.0 x ULN); patients without liver metastases: AST and ALT ≤ 2.5 x ULN, patients with documented liver metastases: AST and ALT ≤ 5 x ULN - Renal function: estimated glomerular filtration rate (eGFR)> 30 mL/min/1.73m² --- L858R ---