Small Cell Lung Cancer
Conditions
Keywords
small cell lung cancer, atezolizumab, IFCT, Real-world study
Brief summary
CLINATEZO cohort will evaluate overall survival, real world progression-free survival, best response and duration of treatment in patients with advanced, metastatic Small Cell Lung Cancer (SCLC) who received atezolizumab combined with chemotherapy part of the French Early Access Program (ATU). Subsequent treatments (treatment delivered immediately after treatment with atezolizumab and chemotherapy) will be recorded. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.
Detailed description
Standard-of-care first-line treatment for advanced, metastatic Small Cell Lung Cancer is platinum chemotherapy (carboplatin or cisplatin) with etoposide. Despite response rates of 60 to 65%, limited progress has been made in more than two decades; outcomes remain poor, with a median overall survival of approximately 10 months. Small cell lung cancer has a high mutation burden, which suggests that these tumors may be immunogenic and could respond to immune-checkpoint inhibitors. Atezolizumab is a humanized monoclonal anti-programmed death ligand 1 (PD-L1) antibody that inhibits PD-L1-programmed death 1 (PD-1) and PD-L1-B7-1 signaling and restores tumor-specific T-cell immunity. The addition of atezolizumab to chemotherapy in the first-line treatment of advanced, metastatic Small Cell Lung Cancer has been granted access for patients in France part of an Early access program (ATU), in May 2019.
Interventions
OTHERatezolizumab
observational
Sponsors
Roche Pharma AG
GFPC
Intergroupe Francophone de Cancerologie Thoracique
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer at time of initiation of treatment with atezolizumab and chemotherapy. * Patients who were informed about the study and accepted for their data to be collected. * Patients who received at least one dose of treatment with atezolizumab and chemotherapy as part of the French Early Access Program (ATU program) and have been accepted within this ATU program * Selection period spans from May 6th 2019 until January 31st 2020 for initiation of treatment with atezolizumab and chemotherapy.
Exclusion criteria
* Patients enrolled in a clinical trial assessing treatment with a combination of atezolizumab and chemotherapy. (ATU was granted to patients unable to meet eligibility criteria for on-going recruiting trials, unable to participate to other clinical trials, or because other medical interventions were not considered appropriate or acceptable). * Patients who were included in the French Early Access Program (ATU program) but did not receive any atezolizumab and chemotherapy treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | OS will be measured at 6 months, 12 months, 24 months, 3 years and 4 years. | OS is defined as the time from the first dose of treatment with atezolizumab and chemotherapy to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of treatment | Study completion (4 years) | time from first dose of treatment to discontinuation of treatment (interruption of more than 2 months) with atezolizumab and/or chemotherapy |
| Presence of liver metastases | At atezolizumab initiation | yes/no |
| Performance Status | At atezolizumab initiation | score (0/1/2/3/4/5) |
| Pattern of tumor progression | Study completion (4 years) | site of disease progression after treatment with atezolizumab and chemotherapy |
| Best response | Study completion (4 years) | best response recorded from the start of treatment with atezolizumab and chemotherapy until disease progression or start of further anti-cancer treatment |
| Sex | At inclusion | male/female |
| Age | At atezolizumab initiation | years |
| Real-world progression-free survival (rwPFS) | rwPFS will be measured at 6 months, 12 months, 24 months, 3 years and 4 years. | rwPFS is defined as the time from first dose of treatment with atezolizumab and chemotherapy to first occurrence of disease progression or death from any cause during the study |
Countries
France
Outcome results
None listed