IMReal
- Conditions
- 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 therapyNSCLCJ98.4
- Registration Number
- LBCTR2020033423
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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:
oAs monotherapy for the treatment of adult patients with locally advanced/metastatic UC after prior platinum-containing chemotherapy (Cohort 1 LOT2+ mUC).
oAs 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).
oIn 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).
oIn 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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: •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 Outcome Measures
Name Time Method