Atezolizumab Combined With Chemotherapy in Extensive Stage SCLC

NCT04920981 | Completed

• 1 other identifier: IFCT-1905
• Study Type: observational
• Target: 518
• Locations: 1 country
• Sites: 2

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.

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer; atezolizumab; IFCT; Real-world study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pattern of tumor progression

  Study completion (4 years)

• Duration of treatment

  Study completion (4 years)

• Presence of liver metastases

  At atezolizumab initiation

• Performance Status

  At atezolizumab initiation

• Real-world progression-free survival (rwPFS)

  rwPFS will be measured at 6 months, 12 months, 24 months, 3 years and 4 years.

Interventions

atezolizumab OTHER

observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intergroupe Francophone de Cancerologie Thoracique: lead
• Roche Pharma AG: collaborator
• GFPC: collaborator

Study Sites (2)

Chalon-sur-Saône - CH

Chalon-sur-Saône, France

Location

Paris - Institut Curie

Paris, France

Location

Related Links

• Article

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nicolas GIRARD

  Paris - Institut Curie

  PRINCIPAL INVESTIGATOR

• Lionel FALCHERO

  Chalon-sur-Saône - CH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: June 10, 2021
• Study Start: February 2, 2021
• Primary Completion: November 24, 2021
• Study Completion: September 1, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

FR (2)