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NCT Number: NCT04920981

Atezolizumab Combined With Chemotherapy in Extensive Stage SCLC

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.

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chalon-sur-Saône - CH, Chalon-sur-Saône, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

atezolizumab

Other

observational

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pattern of tumor progression

    Time frame: Study completion (4 years)

    site of disease progression after treatment with atezolizumab and chemotherapy

  2. 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

  3. Presence of liver metastases

    Time frame: At atezolizumab initiation

    yes/no

  4. Performance Status

    Time frame: At atezolizumab initiation

    score (0/1/2/3/4/5)

  5. 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

  6. 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

  7. Sex

    Time frame: At inclusion

    male/female

  8. Age

    Time frame: At atezolizumab initiation

    years

Sponsors and collaborators

Lead sponsor

Intergroupe Francophone de Cancerologie Thoracique

Other

Collaborators

  • GFPC
  • Roche Pharma AG

Registry information

Official study 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).

Acronym: CLINATEZO

Important dates

Study start
2021
Primary completion
2021
Study completion
2024
First posted
Jun 10, 2021
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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