Lung CancerNCT03505515
Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced Lung Cancer
An observational study of Lung Cancer and Non-small Cell Lung Cancer NSCLC, run by Bristol-Myers Squibb at 1 site in China.
Trial summary
The purpose of the study is to document real-world pattern of care, outcomes and health resource use for participants diagnosed with and receiving treatment for advanced Non-small cell lung cancer (NSCLC) and extensive disease Small cell lung cancer (SCLC) in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell Lung Cancer NSCLC, Small Cell Lung Cancer SCLC
- Type of treatment
- Injection or infusion
- How many people
- 6,205 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2017to 11 Sep 2020
- 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 diagnosed with and receiving treatment for advanced NSCLC and extensive disease SCLC in China.
Who may be able to join
- Histologically confirmed advanced NSCLC (IIIB/IV) and extensive disease SCLC with pathology/cytology record between 1-Dec-2013 and 30-Nov-2014
- Received inpatient treatment more than twice (inclusive) at a selected site. For hospitals with outpatient records, patients receiving oral TKI therapy and routinely (more than twice a year) followed up outpatient will be included although no inpatient records. For hospitals with outpatient chemotherapy center, patients will be include if they were prescribed with chemotherapy and routinely (more than twice a year, inclusive) followed up outpatient in the hospital
- 18 years of age or older at initial diagnosis of IIIB/IV NSCLC and extensive disease SCLC
Who cannot join
- Patients who have participated in or are attending clinical trials receiving active LC therapy
- Unknown initial diagnosis time and initial treatment time.
- For hospitals without outpatient chemo therapy center, patients who were prescribed with chemo therapy but with no inpatient records will be excluded
- Patients who received inpatient therapy for one time and were not routinely (more than twice a year, inclusive) followed up outpatient will be excluded
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced/Metastatic Lung Cancer: a Retrospective Observational Study
The purpose of the study is to document real-world pattern of care, outcomes and health resource use for participants diagnosed with and receiving treatment for advanced Non-small cell lung cancer (NSCLC) and extensive disease Small cell lung cancer (SCLC) in China.
- 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 |
|---|---|---|
| Lung Cancer Patricipants in China | Participants with advanced/metastatic lung cancer (advanced NSCLC (IIIB/IV) and extensive disease SCLC) in China |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants receiving first-line systemic therapy
Proportion of patients receiving first-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Measured: Approximately 36 months
Proportion of participants receiving second-line systemic therapy
Proportion of patients receiving second-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Measured: Approximately 36 months
Proportion of participants receiving third-line systemic therapy
Proportion of patients receiving third-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Measured: Approximately 36 months
Proportion of participants receiving fourth-line systemic therapy
Proportion of patients receiving fourth-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Measured: Approximately 36 months
Distribution of first-line regimens
All chemotherapy, radiation and/or biologic drugs given to a patient during the first 28 days after initiation of treatment
Measured: Approximately 36 months
Distribution of subsequent regimens
All chemotherapy, radiation and/or biologic drugs given to a patient following first-line regimen
Measured: Approximately 36 months
Distribution of first-line treatment duration
Calculated by the difference between the treatment start date of the first observed drug in the regimen and the last observed date of the regimen
Measured: Approximately 36 months
Distribution of subsequent treatment duration
Calculated by the difference between the treatment start date of the first observed drug in the regimen and the last observed date of the regimen
Measured: Approximately 36 months
Distribution of first-line therapy completion rate
Completion of more than 4 cycles
Measured: Approximately 36 months
Distribution of subsequent therapy completion rate
Completion of more than 4 cycles
Measured: Approximately 36 months
Secondary outcomes (10)
Distribution of patient demographic data
Measured: At baseline
Distribution of disease characteristic data
Measured: At baseline
Distribution of Overall Survival from first observed diagnosis to death
Measured: At baseline
Distribution of Overall Survival from the initiation of first-line systemic anti-cancer therapy to death
Measured: At baseline
Distribution of Overall Survival from the initiation of second-line systemic anti-cancer therapy to death
Measured: At baseline
Distribution of Overall Survival from the initiation of third-line systemic anti-cancer therapy to death
Measured: At baseline
Distribution of Overall Survival from the initiation of fourth-line systemic anti-cancer therapy to death
Measured: At baseline
Distribution of other cancer-directed therapies
Distribution of other cancer-directed therapies including surgery and radiation as well as supportive care
Measured: Approximately 36 months
Distribution of Interval of Therapy
Measured: Up to 36 months
Distribution of Lung Cancer related direct health care costs
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start7 Dec 2017
- Primary completion11 Sep 2020
- Study completion11 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 6,205 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
- NCT03505515
- Sponsor's protocol ID
- CA209-693
- Status last verified
- Sep 2021
- First submitted
- 6 Apr 2018
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qiu B, Li G, Luo F, Cai X, Wu L, Chen J, Hu Y, Tang Z, Yang S, He J. Treatment patterns, clinical outcomes, and healthcare resource use associated with advanced/metastatic lung cancer in China: protocol for a retrospective observational study. Transl Lung Cancer Res. 2020 Dec;9(6):2460-2468. doi: 10.21037/tlcr-20-1269.
PubMed 33489806
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced/Metastatic Lung Cancer: a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT03505515
- Acronym / sponsor ID
- CA209-693
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,205 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 23 Apr 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.
The purpose of the study is to document real-world pattern of care, outcomes and health resource use for participants diagnosed with and receiving treatment for advanced Non-small cell lung cancer (NSCLC) and extensive disease Small cell lung cancer (SCLC) in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer Patricipants in China | – | –Participants with advanced/metastatic lung cancer (advanced NSCLC (IIIB/IV) and extensive disease SCLC) in China |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with and receiving treatment for advanced NSCLC and extensive disease SCLC in China.
Key inclusion criteria (3 listed)
- Histologically confirmed advanced NSCLC (IIIB/IV) and extensive disease SCLC with pathology/cytology record between 1-Dec-2013 and 30-Nov-2014
- Received inpatient treatment more than twice (inclusive) at a selected site. For hospitals with outpatient records, patients receiving oral TKI therapy and routinely (more than twice a year) followed up outpatient will be included although no inpatient records. For hospitals with outpatient chemotherapy center, patients will be include if they were prescribed with chemotherapy and routinely (more than twice a year, inclusive) followed up outpatient in the hospital
- 18 years of age or older at initial diagnosis of IIIB/IV NSCLC and extensive disease SCLC
Key exclusion criteria (5 listed)
- Patients who have participated in or are attending clinical trials receiving active LC therapy
- Unknown initial diagnosis time and initial treatment time.
- For hospitals without outpatient chemo therapy center, patients who were prescribed with chemo therapy but with no inpatient records will be excluded
- Patients who received inpatient therapy for one time and were not routinely (more than twice a year, inclusive) followed up outpatient will be excluded
- Other protocol defined inclusion/exclusion criteria could 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
Proportion of participants receiving first-line systemic therapy
Time frame: Approximately 36 months
Proportion of patients receiving first-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Proportion of participants receiving second-line systemic therapy
Time frame: Approximately 36 months
Proportion of patients receiving second-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Proportion of participants receiving third-line systemic therapy
Time frame: Approximately 36 months
Proportion of patients receiving third-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Proportion of participants receiving fourth-line systemic therapy
Time frame: Approximately 36 months
Proportion of patients receiving fourth-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Distribution of first-line regimens
Time frame: Approximately 36 months
All chemotherapy, radiation and/or biologic drugs given to a patient during the first 28 days after initiation of treatment
Distribution of subsequent regimens
Time frame: Approximately 36 months
All chemotherapy, radiation and/or biologic drugs given to a patient following first-line regimen
Distribution of first-line treatment duration
Time frame: Approximately 36 months
Calculated by the difference between the treatment start date of the first observed drug in the regimen and the last observed date of the regimen
Distribution of subsequent treatment duration
Time frame: Approximately 36 months
Calculated by the difference between the treatment start date of the first observed drug in the regimen and the last observed date of the regimen
Distribution of first-line therapy completion rate
Time frame: Approximately 36 months
Completion of more than 4 cycles
Distribution of subsequent therapy completion rate
Time frame: Approximately 36 months
Completion of more than 4 cycles
10 secondary outcomes
Distribution of patient demographic data
Time frame: At baseline
Distribution of disease characteristic data
Time frame: At baseline
Distribution of Overall Survival from first observed diagnosis to death
Time frame: At baseline
Distribution of Overall Survival from the initiation of first-line systemic anti-cancer therapy to death
Time frame: At baseline
Distribution of Overall Survival from the initiation of second-line systemic anti-cancer therapy to death
Time frame: At baseline
Distribution of Overall Survival from the initiation of third-line systemic anti-cancer therapy to death
Time frame: At baseline
Distribution of Overall Survival from the initiation of fourth-line systemic anti-cancer therapy to death
Time frame: At baseline
Distribution of other cancer-directed therapies
Time frame: Approximately 36 months
Distribution of Interval of Therapy
Time frame: Up to 36 months
Distribution of Lung Cancer related direct health care costs
Time frame: Up to 36 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 14 Sep 2021.
- Derived from this study: PubMed 33489806Qiu B, Li G, Luo F, Cai X, Wu L, Chen J, Hu Y, Tang Z, Yang S, He J. Treatment patterns, clinical outcomes, and healthcare resource use associated with advanced/metastatic lung cancer in China: protocol for a retrospective observational study. Transl Lung Cancer Res. 2020 Dec;9(6):2460-2468. doi: 10.21037/tlcr-20-1269.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Non-small Cell Lung Cancer NSCLC, run by Bristol-Myers Squibb at 1 site in China.
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 3 inclusion and 5 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 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Proportion of participants receiving first-line systemic therapy (time frame: Approximately 36 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03505515, which also lists 1 linked publication.
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 14 Sep 2021.