Non-Small Cell Lung Cancer, Lung Cancer, CancerNCT02458651
Disease Characteristics, Treatment Patterns and Clinical Outcomes in Patients With Newly Diagnosed Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) in China
An observational study of Non-Small Cell Lung Cancer, Lung Cancer, Cancer, run by Hoffmann-La Roche at 11 sites in China.
Trial summary
The purpose of this observational study is to describe patient and disease characteristics as well as treatment patterns in Chinese patients with unresectable stage IIIB or IV non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Lung Cancer, Lung Cancer, Cancer
- How many people
- 1,378 participants
- Where
- 11 sitesChina
- Study dates
- 26 Jun 2015to 30 Oct 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with newly diagnosed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
Who may be able to join
- Histologically/cytologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
- Received at least one anti-cancer treatment targeting unresectable Stage IIIB or IV NSCLC in the study site after study initiation
- Radiographic evidence of disease
Who cannot join
- Prior systematic treatment for unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
- Participation in any anti-cancer, regimen-specified clinical study of first-line treatment for unresectable Stage IIIB or IV NSCLC.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021
the First Hospital of Jilin University
Changchun, 130021
Sichuan Provincial Cancer Hospital
Chengdu, 610041
Third Affiliated Hospital of Third Military Medical University
Chongqing, 400042
Fujian Cancer Hospital
Fuzhou, 350014
Harbin Medical University Cancer Hospital
Harbin, 150081
The First Affiliate Hospital of Guangxi Medical University
Nanning, 530021
Zhongshan Hospital Fudan University
Shanghai, 200032
Shanghai First People's Hospital
Shanghai, 200080
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
Wuhan, 430023
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061
About this study
Official title: An Observational Study of Patients With Newly Diagnosed Unresectable Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) in China
The purpose of this observational study is to describe patient and disease characteristics as well as treatment patterns in Chinese patients with unresectable stage IIIB or IV non-small cell lung cancer (NSCLC). In addition, this study characterizes the clinical outcomes for various populations of patients defined by clinical and tumor characteristics, treatment patterns, and hospital category defined by city tier and geographic region.
- Being tested
- No intervention
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention administered in this study
| Study group | Role | What they receive |
|---|---|---|
| Tier 1 and North | Site as described by tier level of the city where the site is located and by geographical location: Tier 1 city in northern region of China Receives: Other: No intervention | |
| Tier 1 and South | Site as described by tier level of the city where the site is located and by geographical location: Tier 1 city in southern region of China Receives: Other: No intervention | |
| Tier 2 and Middle | Site as described by tier level of the city where the site is located and by geographical location: Tier city in middle region of China Receives: Other: No intervention | |
| Tier 2 and North | Site as described by tier level of the city where the site is located and by geographical location: Tier 2 city in northern region of China Receives: Other: No intervention | |
| Tier 2 and South Eastern | Site as described by tier level of the city where the site is located and by geographical location: Tier 2 city in south eastern region of China Receives: Other: No intervention | |
| Tier 2 and South Western | Site as described by tier level of the city where the site is located and by geographical location: Tier 2 city in south western region of China Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic and Socio-Behavioral Characteristics
Measured: At enrollment
Medical History Characteristics
Measured: At enrollment
Score Tumor Characteristics Based on Tumor Histology, Stage, Grade, and Lung Cancer Molecular Profile
Measured: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status
Measured: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Treatment Patterns of First-Line and Subsequent Treatments
Measured: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Progression-Free Survival (PFS)
Measured: From enrollment to end of study up to 1.5 years
Overall Survival (OS)
Measured: From enrollment to end of study up to 1.5 years
Secondary outcomes (4)
Score Health Economic Status Based on Household Income, Diagnosis and Treatment Costs, and Insurance Coverage
Measured: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Percentage of Serious Adverse Events (SAEs)
Measured: From enrollment to end of study up to 1.5 years
Percentage of Adverse Events (AEs)
Measured: From enrollment to end of study up to 1.5 years
Percentage of Non-Serious AEs of Special Interest (AESIs)
Measured: From enrollment to end of study up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study start26 Jun 2015
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer, Lung Cancer, CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Prospective
- Enrolment
- 1,378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458651
- Sponsor's protocol ID
- YO29443
- Status last verified
- Nov 2018
- First submitted
- 28 May 2015
- Last updated
- 9 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Patients With Newly Diagnosed Unresectable Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) in China
- ClinicalTrials.gov ID
- NCT02458651
- Acronym / sponsor ID
- YO29443
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,378 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2015 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 1 Jun 2015 (estimated)
- 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 this observational study is to describe patient and disease characteristics as well as treatment patterns in Chinese patients with unresectable stage IIIB or IV non-small cell lung cancer (NSCLC). In addition, this study characterizes the clinical outcomes for various populations of patients defined by clinical and tumor characteristics, treatment patterns, and hospital category defined by city tier and geographic region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Tier 1 and North | – | Other: No interventionSite as described by tier level of the city where the site is located and by geographical location: Tier 1 city in northern region of China |
| Tier 1 and South | – | Other: No interventionSite as described by tier level of the city where the site is located and by geographical location: Tier 1 city in southern region of China |
| Tier 2 and Middle | – | Other: No interventionSite as described by tier level of the city where the site is located and by geographical location: Tier city in middle region of China |
| Tier 2 and North | – | Other: No interventionSite as described by tier level of the city where the site is located and by geographical location: Tier 2 city in northern region of China |
| Tier 2 and South Eastern | – | Other: No interventionSite as described by tier level of the city where the site is located and by geographical location: Tier 2 city in south eastern region of China |
| Tier 2 and South Western | – | Other: No interventionSite as described by tier level of the city where the site is located and by geographical location: Tier 2 city in south western region of China |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with newly diagnosed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
Key inclusion criteria (3 listed)
- Histologically/cytologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
- Received at least one anti-cancer treatment targeting unresectable Stage IIIB or IV NSCLC in the study site after study initiation
- Radiographic evidence of disease
Key exclusion criteria (2 listed)
- Prior systematic treatment for unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
- Participation in any anti-cancer, regimen-specified clinical study of first-line treatment for unresectable Stage IIIB or IV NSCLC.
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 |
|---|---|---|
| No interventionNo intervention administered in this study | Other | Tier 1 and North, Tier 1 and South, Tier 2 and Middle, Tier 2 and North, Tier 2 and South Eastern, Tier 2 and South Western |
Primary outcome
Demographic and Socio-Behavioral Characteristics
Time frame: At enrollment
Medical History Characteristics
Time frame: At enrollment
Score Tumor Characteristics Based on Tumor Histology, Stage, Grade, and Lung Cancer Molecular Profile
Time frame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Treatment Patterns of First-Line and Subsequent Treatments
Time frame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Progression-Free Survival (PFS)
Time frame: From enrollment to end of study up to 1.5 years
Overall Survival (OS)
Time frame: From enrollment to end of study up to 1.5 years
4 secondary outcomes
Score Health Economic Status Based on Household Income, Diagnosis and Treatment Costs, and Insurance Coverage
Time frame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Percentage of Serious Adverse Events (SAEs)
Time frame: From enrollment to end of study up to 1.5 years
Percentage of Adverse Events (AEs)
Time frame: From enrollment to end of study up to 1.5 years
Percentage of Non-Serious AEs of Special Interest (AESIs)
Time frame: From enrollment to end of study up to 1.5 years
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 9 Nov 2018.
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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.
Clinical Trials study director
Hoffmann-La Roche
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, Lung Cancer, Cancer, run by Hoffmann-La Roche at 11 sites 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 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 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Demographic and Socio-Behavioral Characteristics (time frame: At enrollment). 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 9 Nov 2018.