CLINATEZO: Atezolizumab Combined With Chemotherapy in Extensive Stage SCLC

Sponsor

Intergroupe Francophone de Cancerologie Thoracique (Other)

Overall Status

Recruiting

CT.gov ID

NCT04920981

Collaborator

Roche Pharma AG (Industry), GFPC (Other)

500

Enrollment

Locations

Anticipated Duration (Months)

250

Patients Per Site

13.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Other: atezolizumab

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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).

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Aug 31, 2022

Outcome Measures

Primary Outcome Measures

Overall Survival (OS) [At 12 months]
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 12 months and 24 months
Overall Survival (OS) [At 24 months]
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 12 months and 24 months

Secondary Outcome Measures

Pattern of tumor progression [At sudy completion (24 months)]
site of disease progression after treatment with atezolizumab and chemotherapy
Duration of treatment [At sudy completion (24 months)]
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 arezolizumab initiation [At 6 months from inclusion]
yes/no
Performance Status at atezolizumab initiation [At 6 months from inclusion]
score (0/1/2/3/4/5)
Performance Status at post-atezolizumab treatments initiation [At sudy completion (24 months)]
score (0/1/2/3/4/5)
Real-world progression-free survival [At sudy completion (24 months)]
time from first dose of treatment with atezolizumab and chemotherapy to first occurrence of disease progression or death from any cause during the study
Best response [At sudy completion (24 months)]
best response recorded from the start of treatment with atezolizumab and chemotherapy until disease progression or start of further anti-cancer treatment
Sex [At 6 months from inclusion]
male/female
Age at initiation of atezolizumab treatment [At 6 months from inclusion]
years

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.