Atezolizumab Combined With Chemotherapy in Extensive Stage SCLC

Small Cell Lung Cancer Clinical Trial

— CLINATEZO  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04920981
• Other study ID #: IFCT-1905
• Status: Completed
• Start date: February 2, 2021
• Est. completion date: November 24, 2021

Study information

• Verified date: January 2023
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: November 24, 2021
• Est. primary completion date: November 24, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Other:
• atezolizumab
observational

Locations

Country	Name	City	State
France	Chalon-sur-Saône - CH	Chalon-sur-Saône
France	Paris - Institut Curie	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique	GFPC, Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 12 months and 24 months	At 12 months
Primary	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 12 months and 24 months	At 24 months
Secondary	Pattern of tumor progression	site of disease progression after treatment with atezolizumab and chemotherapy	At sudy completion (24 months)
Secondary	Duration of treatment	time from first dose of treatment to discontinuation of treatment (interruption of more than 2 months) with atezolizumab and/or chemotherapy	At sudy completion (24 months)
Secondary	Presence of liver metastases at arezolizumab initiation	yes/no	At 6 months from inclusion
Secondary	Performance Status at atezolizumab initiation	score (0/1/2/3/4/5)	At 6 months from inclusion
Secondary	Performance Status at post-atezolizumab treatments initiation	score (0/1/2/3/4/5)	At sudy completion (24 months)
Secondary	Real-world progression-free survival	time from first dose of treatment with atezolizumab and chemotherapy to first occurrence of disease progression or death from any cause during the study	At sudy completion (24 months)
Secondary	Best response	best response recorded from the start of treatment with atezolizumab and chemotherapy until disease progression or start of further anti-cancer treatment	At sudy completion (24 months)
Secondary	Sex	male/female	At 6 months from inclusion
Secondary	Age at initiation of atezolizumab treatment	years	At 6 months from inclusion