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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
| GFPC | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atezolizumab | Other | observational |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the first dose of treatment with atezolizumab and chemotherapy to death from any cause. | OS will be measured at 6 months, 12 months, 24 months, 3 years and 4 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern of tumor progression | site of disease progression after treatment with atezolizumab and chemotherapy | Study completion (4 years) |
| Duration of treatment | time from first dose of treatment to discontinuation of treatment (interruption of more than 2 months) with atezolizumab and/or chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer at time of initiation of treatment with atezolizumab and chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas GIRARD | Paris - Institut Curie | Principal Investigator |
| Lionel FALCHERO | Chalon-sur-Saône - CH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chalon-sur-Saône - CH | Chalon-sur-Saône | France | ||||
| Paris - Institut Curie |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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| Study completion (4 years) |
| Presence of liver metastases | yes/no | At atezolizumab initiation |
| Performance Status | score (0/1/2/3/4/5) | At atezolizumab initiation |
| Real-world progression-free survival (rwPFS) | 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 | rwPFS will be measured at 6 months, 12 months, 24 months, 3 years and 4 years. |
| Best response | best response recorded from the start of treatment with atezolizumab and chemotherapy until disease progression or start of further anti-cancer treatment | Study completion (4 years) |
| Sex | male/female | At inclusion |
| Age | years | At atezolizumab initiation |
| Paris |
| France |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |