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Atezolizumab Combined With Chemotherapy in Extensive Stage SCLC (CLINATEZO)

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ClinicalTrials.gov Identifier: NCT04920981
Recruitment Status : Completed
First Posted : June 10, 2021
Last Update Posted : January 6, 2023
Sponsor:
Collaborators:
Roche Pharma AG
GFPC
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

Study Description
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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
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
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Study Type : Observational
Actual Enrollment : 518 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 : February 2, 2021
Actual Primary Completion Date : November 24, 2021
Actual Study Completion Date : November 24, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: atezolizumab
    observational

Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 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

  2. Overall Survival (OS) [ Time Frame: 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 :
  1. Pattern of tumor progression [ Time Frame: At sudy completion (24 months) ]
    site of disease progression after treatment with atezolizumab and chemotherapy

  2. Duration of treatment [ Time Frame: 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

  3. Presence of liver metastases at arezolizumab initiation [ Time Frame: At 6 months from inclusion ]
    yes/no

  4. Performance Status at atezolizumab initiation [ Time Frame: At 6 months from inclusion ]
    score (0/1/2/3/4/5)

  5. Performance Status at post-atezolizumab treatments initiation [ Time Frame: At sudy completion (24 months) ]
    score (0/1/2/3/4/5)

  6. Real-world progression-free survival [ Time Frame: 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

  7. Best response [ Time Frame: 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

  8. Sex [ Time Frame: At 6 months from inclusion ]
    male/female

  9. Age at initiation of atezolizumab treatment [ Time Frame: At 6 months from inclusion ]
    years


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04920981


Locations
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France
Chalon-sur-Saône - CH
Chalon-sur-Saône, France
Paris - Institut Curie
Paris, France
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Roche Pharma AG
GFPC
Investigators
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Principal Investigator: Nicolas GIRARD Paris - Institut Curie
Principal Investigator: Lionel FALCHERO Chalon-sur-Saône - CH
More Information
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Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT04920981    
Other Study ID Numbers: IFCT-1905
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: January 2023
Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
small cell lung cancer
atezolizumab
IFCT
Real-world study
Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Atezolizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents