Lung CancerNCT03425825
Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)
An observational study of Lung Cancer, run by Bristol-Myers Squibb at 2 sites in 2 countries.
Trial summary
Non-interventional, retrospective study of advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]) with the aim to produce evidence across different SCLC treatment lines to characterize the clinical and economic burden of the disease in Europe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 764 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Dec 2016to 24 Jan 2019
- 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: Advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]).
Who may be able to join
- Cohort 1 and 2:
- Patients 18 years of age or older at SCLC diagnosis
- Confirmed diagnosis of SCLC within the patient identification period (between October 2013 and October 2015)
- Initiated on first-line treatment (radiotherapy and/or chemotherapy) for their SCLC
- Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- Signed informed consent (where required as per local requirements)
Show all 12Show fewer
- Cohort 3:
- Patients 18 years of age or older at SCLC diagnosis
- Confirmed diagnosis of SCLC not earlier than October 2013
- Initiated on second-line treatment due to relapse after first-line therapy not later than August 2016
- Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- Signed informed consent (where required as per local requirements)
Who cannot join
- Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period.
- Other Inclusion/Exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe
Non-interventional, retrospective study of advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]) with the aim to produce evidence across different SCLC treatment lines to characterize the clinical and economic burden of the disease in Europe.
- Conditions
- Lung Cancer
- Keywords
- Small Cell Lung Cancer (SCLC)
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LD-SCLC receiving 1st line treatment | patients with LD-SCLC receiving first-line treatment, including potential maintenance treatment | |
| ED-SCLC receiving 1st line treatment | patients with ED-SCLC receiving first-line treatment, including potential maintenance treatment | |
| relapsed/refractory receiving 2nd or later-line treatment | relapsed/refractory patients receiving second- or later-line treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Patient Demographic Characteristics
Characteristics include:
Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors
Measured: At baseline
Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment
Characteristics include:
Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
Measured: At baseline
Distribution of Patient Clinical Characteristics in patients with LD-SCLC
Characteristics include:
Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
Measured: At baseline
Distribution of Patient Clinical Characteristics in patients with ED-SCLC
Characteristics include:
Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
Measured: At baseline
Distribution of treatment patterns in patients with ED-SCLC
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Measured: Approximately 44 months
Distribution of treatment patterns in patients with LD-SCLC
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Measured: Approximately 44 months
Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Measured: Approximately 44 months
Secondary outcomes (10)
Composite of SCLC-related healthcare resource utilization (HCRU)
HCRU will include hospitalizations, emergency visits, outpatient visits, treatments received (including treatments prescribed to manage AEs), diagnostic tests and procedures, surgery, and ancillary services.
Measured: Approximately 44 months
Overall survival (OS)
Measured: Approximately 44 months
Progression-free survival (PFS)
Measured: Approximately 44 months
Objective response rate (ORR)
Measured: Approximately 44 months
Mortality rate
Measured: Approximately 44 months
Treatment-related adverse events (AEs) leading to discontinuation
Measured: Approximately 44 months
Incidence of surgery as cancer-directed therapy
To describe the use of surgery in the management of LD-SCLC and ED-SCLC patients having relapsed
Measured: Approximately 44 months
Incidence of radiation therapy as cancer-directed therapy
To describe the use of radiation therapy in the management of LD-SCLC and ED-SCLC patients having relapsed
Measured: Approximately 44 months
Incidence of best supportive care (BSC)
To describe the use of best supportive care (BSC) in the management of LD-SCLC and ED-SCLC patients having relapsed
Measured: Approximately 44 months
Incidence of palliative care
To describe the use of palliative care in the management of LD-SCLC and ED-SCLC patients having relapsed
Measured: Approximately 44 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start15 Dec 2016
- Primary completion24 Jan 2019
- Study completion24 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425825
- Sponsor's protocol ID
- CA209-913
- Status last verified
- Jan 2022
- First submitted
- 13 Oct 2017
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe
- ClinicalTrials.gov ID
- NCT03425825
- Acronym / sponsor ID
- CA209-913
- Conditions
- Lung Cancer
- Keywords
- Small Cell Lung Cancer (SCLC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 8 Feb 2018 (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.
Non-interventional, retrospective study of advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]) with the aim to produce evidence across different SCLC treatment lines to characterize the clinical and economic burden of the disease in Europe.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LD-SCLC receiving 1st line treatment | – | –patients with LD-SCLC receiving first-line treatment, including potential maintenance treatment |
| ED-SCLC receiving 1st line treatment | – | –patients with ED-SCLC receiving first-line treatment, including potential maintenance treatment |
| relapsed/refractory receiving 2nd or later-line treatment | – | –relapsed/refractory patients receiving second- or later-line treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]).
Key inclusion criteria (12 listed)
- Patients 18 years of age or older at SCLC diagnosis
- Confirmed diagnosis of SCLC within the patient identification period (between October 2013 and October 2015)
- Initiated on first-line treatment (radiotherapy and/or chemotherapy) for their SCLC
- Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- Signed informed consent (where required as per local requirements)
Key exclusion criteria (2 listed)
- Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period.
- Other Inclusion/Exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distribution of Patient Demographic Characteristics
Time frame: At baseline
Characteristics include: Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors
Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment
Time frame: At baseline
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
Distribution of Patient Clinical Characteristics in patients with LD-SCLC
Time frame: At baseline
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
Distribution of Patient Clinical Characteristics in patients with ED-SCLC
Time frame: At baseline
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
Distribution of treatment patterns in patients with ED-SCLC
Time frame: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Distribution of treatment patterns in patients with LD-SCLC
Time frame: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment
Time frame: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
10 secondary outcomes
Composite of SCLC-related healthcare resource utilization (HCRU)
Time frame: Approximately 44 months
Overall survival (OS)
Time frame: Approximately 44 months
Progression-free survival (PFS)
Time frame: Approximately 44 months
Objective response rate (ORR)
Time frame: Approximately 44 months
Mortality rate
Time frame: Approximately 44 months
Treatment-related adverse events (AEs) leading to discontinuation
Time frame: Approximately 44 months
Incidence of surgery as cancer-directed therapy
Time frame: Approximately 44 months
Incidence of radiation therapy as cancer-directed therapy
Time frame: Approximately 44 months
Incidence of best supportive care (BSC)
Time frame: Approximately 44 months
Incidence of palliative care
Time frame: Approximately 44 months
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 26 Jan 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Bristol-Myers Squibb at 2 sites in 2 countries.
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 12 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 26 Jan 2022. 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 Spain, United Kingdom. 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?
Distribution of Patient Demographic Characteristics (time frame: At baseline). The study lists 7 primary outcomes in all. 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 26 Jan 2022.