Small Cell Lung CancerCLINATEZONCT04920981
Atezolizumab Combined With Chemotherapy in Extensive Stage SCLC
An observational study of Small Cell Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- atezolizumab
- How many people
- 518 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Feb 2021to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer at time of initiation of treatment with atezolizumab and chemotherapy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Chalon-sur-Saône - CH
Chalon-sur-Saône
Paris - Institut Curie
Paris
About this study
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).
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.
Read the 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.
- Conditions
- Small Cell Lung Cancer
- Being tested
- atezolizumab
- Keywords
- small cell lung cancer, atezolizumab, IFCT, Real-world study
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atezolizumabOther
observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from the first dose of treatment with atezolizumab and chemotherapy to death from any cause.
Measured: OS will be measured at 6 months, 12 months, 24 months, 3 years and 4 years.
Secondary outcomes (8)
Pattern of tumor progression
site of disease progression after treatment with atezolizumab and chemotherapy
Measured: 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
Measured: Study completion (4 years)
Presence of liver metastases
yes/no
Measured: At atezolizumab initiation
Performance Status
score (0/1/2/3/4/5)
Measured: 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
Measured: 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
Measured: Study completion (4 years)
Sex
male/female
Measured: At inclusion
Age
years
Measured: At atezolizumab initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start2 Feb 2021
- Primary completion24 Nov 2021
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, GFPC
- Responsible party
- Sponsor
- Investigators
- Nicolas GIRARD, Principal investigator, Paris - Institut CurieLionel FALCHERO, Principal investigator, Chalon-sur-Saône - CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920981
- Sponsor's protocol ID
- IFCT-1905
- Acronym
- CLINATEZO
- Status last verified
- Nov 2024
- First submitted
- 28 Apr 2021
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04920981
- Acronym / sponsor ID
- CLINATEZO / IFCT-1905
- Conditions
- Small Cell Lung Cancer
- Keywords
- small cell lung cancer, atezolizumab, IFCT, Real-world study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Intergroupe Francophone de Cancerologie ThoraciqueUniversity, hospital or other
- Collaborators
- Roche Pharma AG, GFPC
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer at time of initiation of treatment with atezolizumab and chemotherapy
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atezolizumabobservational | Other | – |
Primary outcome
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.
8 secondary outcomes
Pattern of tumor progression
Time frame: Study completion (4 years)
Duration of treatment
Time frame: Study completion (4 years)
Presence of liver metastases
Time frame: At atezolizumab initiation
Performance Status
Time frame: 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.
Best response
Time frame: Study completion (4 years)
Sex
Time frame: At inclusion
Age
Time frame: At atezolizumab initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- ArticleLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas GIRARD principal investigator
Paris - Institut Curie
Lionel FALCHERO principal investigator
Chalon-sur-Saône - CH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: OS will be measured at 6 months, 12 months, 24 months, 3 years and 4 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.