Patients diagnosed with locally advanced/metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Patients with epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK)- positive tumor mutations should also have received targeted therapy NSCLC
Conditions
Interventions
Sponsors
F. HOFFMANN-LA ROCHE LTD
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: 1. Patient must have one of the following confirmed diagnoses for which atezolizumab is locally approved in the SmPC: o As monotherapy for the treatment of adult patients with locally advanced/metastatic UC after prior platinum-containing chemotherapy (Cohort 1 LOT2+ mUC). o As monotherapy for the treatment of adult patients with locally advanced/metastatic NSCLC after prior chemotherapy. Patients with EGFR activating mutations or ALK- positive tumour mutations should also have received targeted therapy (i.e. ALK /EGFR-TKIs) before receiving atezolizumab (Cohort 2 LOT2+ NSCLC). o In combination with bevacizumab, paclitaxel and carboplatin for the first line treatment of adult patients with metastatic non-squamous NSCLC. Patients with EGFR activating mutations or ALK- positive tumour mutations should also have received targeted therapy (i.e. ALK /EGFR-TKIs). (Cohort 3 LOT1 NSCLC). o In combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (Cohort 4 LOT1 ES-SCLC) 2. Patient is prescribed atezolizumab therapy for the first time 3. Decision to prescribe atezolizumab must be made and documented prior to inclusion into the study and must follow local clinical practice. 4. Patient is aged = 18 years or older at the index date. 5. Patient has signed an informed consent form according to local regulations. 6. Data collection can only start after the signing of inform consent and not more than 28 days after initiation of atezolizumab. In countries where enrollment is only allowed after the treatment start, enrollment must be preceded by the administration of the first cycle of atezolizumab.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: 1. Patients not receiving treatment for a disease with atezolizumab according to standard of care and in line with the current summary of product characteristics (SPC) or local labelling *. 2. Concomitant anti-cancer therapy at the time of starting atezolizumab on the index date, not part of locally approved combination therapy with atezolizumab. 3. Treatment with atezolizumab as part of a clinical trial or for compassionate use as part of an access or compassionate use program. 4. Patients not receiving atezolizumab, but a biosimilar or non-original biologic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Name: • To estimate overall survival (OS) at two years and at the end of the study.;Timepoints: Overall Survival - OS ;Measure: Time from index date until date of death from any cause;Name: • To estimate overall survival (OS) at two years and at the end of the study.;Timepoints: OS at 2 years ;Measure: Proportion of patients alive 2 years after the index date | — |
Secondary
| Measure | Time frame |
|---|---|
| Name: To evaluate the clinical benefit of atezolizumab;Timepoints: Time to loss of clinical benefit ;Measure: Time from the index date to loss of clinical benefit as assessed by the treating physician (single or multiple reasons possible: e.g. disease progression, deterioration in ECOG performance status, patient preference, death, etc.). Clinical benefit is defined as: • Absence of symptoms and signs indicating unequivocal progression of disease • No decline in ECOG performance status • Absence of tumour progression at critical anatomical sites that cannot be readily managed and stabilized by protocol-allowed medical interventions prior to repeat dosing • Evidence of clinical benefit as assessed by the physician according to local clinical standard of care;Name: To estimate PFS;Timepoints: Progression-free survival - PFS;Measure: Time from index date to death or disease progression (DP; physician assessed according to local clinical standard of care or as per RECIST if available);Name: To estimate the ORR, DCR and DoR;Timepoints: Objective response rate - ORR;Measure: ORR is the proportion of patients who have a BOR of CR or PR. Best overall response (BOR) for each patient is the best response (physician assessed according to local clinical standard of care or as per RECIST if available) achieved after the index date prior to initiation of any subsequent treatment.;Name: To estimate the ORR, DCR and DoR;Timepoints: Time to response;Measure: Time from index date to first objective tumour response, CR or PR (physician assessed according to local clinical standard of care or as per RECIST if available);Name: To estimate the ORR, DCR and DoR;Timepoints: Duration of response - DoR;Measure: Time from first documentation of CR or PR (whichever occurs first) after index until death or PD (physician assessed according to local clinical standard of care or as per RECIST if available);Name: To estimate the ORR, DCR and DoR;Timepoints: Disease control rate - DCR;Measure: Perce | — |
Countries
Argentina, Austria, Belgium, Bulgaria, Croatia, France, Hungary, Italy, Lebanon, Lithuania, Netherlands, Poland, Portugal, Slovenia, Spain, United Kingdom
Contacts
Public ContactDani Abi Gerges
Middle East Institute of Health - University Hospital
Outcome results
None listed