Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920981
Status:
COMPLETED
Last Update Posted:
2023-01-06
First Post:
2021-04-28
Brief Title:
Atezolizumab Combined With Chemotherapy in Extensive Stage SCLC
Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Organization:
Intergroupe Francophone de Cancerologie Thoracique
Study Overview
Official Title:
Real World Effectiveness and Treatment Sequences in Patients With Extensive Stage SCLC Who Received Atezolizumab Combined With Chemotherapy as Part of the French Early Access Program ATU
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLINATEZO
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None