Atezolizumab Combined With Chemotherapy in Extensive Stage SCLC (CLINATEZO)

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).

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.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 518

Contacts and Locations

Study Locations

• France
  • Chalon-sur-Saône, France
    • Chalon-sur-Saône - CH
  • Paris, France
    • Paris - Institut Curie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer at time of initiation of treatment with atezolizumab and chemotherapy

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Intergroupe Francophone de Cancerologie Thoracique
• Collaborators: Roche Pharma AG; GFPC
• Investigators: Principal Investigator: Nicolas GIRARD, Paris - Institut Curie; Principal Investigator: Lionel FALCHERO, Chalon-sur-Saône - CH

Publications and helpful links

Helpful Links

• Article

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2021
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: atezolizumab; small cell lung cancer; IFCT; Real-world study
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Atezolizumab
• Other Study ID Numbers: IFCT-1905