Atezolizumab Combined With Chemotherapy in Extensive Stage SCLC (CLINATEZO)

November 5, 2024 updated by: Intergroupe Francophone de Cancerologie Thoracique

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
Time Frame: OS will be measured at 6 months, 12 months, 24 months, 3 years and 4 years.
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
Time Frame: Study completion (4 years)
site of disease progression after treatment with atezolizumab and chemotherapy
Study completion (4 years)
Duration of treatment
Time Frame: Study completion (4 years)
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
Time Frame: At atezolizumab initiation
yes/no
At atezolizumab initiation
Performance Status
Time Frame: At atezolizumab initiation
score (0/1/2/3/4/5)
At atezolizumab initiation
Real-world progression-free survival (rwPFS)
Time Frame: rwPFS will be measured at 6 months, 12 months, 24 months, 3 years and 4 years.
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
Time Frame: Study completion (4 years)
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
Time Frame: At inclusion
male/female
At inclusion
Age
Time Frame: At atezolizumab initiation
years
At atezolizumab initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCT-1905

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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