Non-Small Cell Lung CancerENLARGE-LungNCT02910999
Real-Life Study With Nivolumab (BMS-936558) in Advanced NSCLC Patients After Prior Chemotherapy
An observational study of Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 1 site in Germany.
Trial summary
This study intends to describe the real-life effectiveness and safety of nivolumab in advanced NSCLC patients in Germany, as well as the patient profile, pattern of use and the quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 868 participants
- Where
- 1 siteGermany
- Study dates
- 9 Aug 2016to 31 Dec 2023
- 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: Both cohorts will be recruited in different sites. Office-based as well as outpatient units in clinics.
Who may be able to join
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC, Stage IIIB/Stage IV
- Decision to initiate a treatment with Nivolumab for the first time already undertaken by physician
- Males and Females, ≥18 years of age
Who cannot join
- Current primary diagnosis of a cancer other than advanced NSCLC. Example: A cancer other than NSCLC that requires systemic or other treatment.
- Pre-treatment with Nivolumab and/or Ipilimumab (pre-treatment with checkpoint-inhibitors other than Nivolumab and Ipilimumab, and Tyrosine Kinase Inhibitors(TKIs) is allowed)
- Current participation in an interventional clinical trial for treatment of NSCLC. (Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. For blinded studies, the treatment administered needs to be known)
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology (Stage IIIB/IV) After Prior Chemotherapy
This study intends to describe the real-life effectiveness and safety of nivolumab in advanced NSCLC patients in Germany, as well as the patient profile, pattern of use and the quality of life.
- Conditions
- Non-Small Cell Lung Cancer
- 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.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC patients with squamous tumor histology | Not described | |
| NSCLC patients with non-squamous tumor histology | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Approximately 5 years
Secondary outcomes (13)
Progression-Free Survival (PFS)
Measured: Approximately 5 years
Overall Response Rate (ORR)
Measured: Approximately 5 years
Best Overall Response Rate (BORR)
Measured: Approximately 5 years
Best Overall Response (BOR)
Measured: Approximately 5 years
Duration of Response (DOR)
Measured: Approximately 5 years
Distribution of socio-demographic characteristics in adult patients diagnosed with advanced NSCLC
Measured: At baseline and for up to 5 years
Distribution of clinical characteristics in adult patients diagnosed with advanced NSCLC
Measured: At baseline and for up to 5 years
Distribution of treatment patterns in adult patients diagnosed with advanced NSCLC
Measured: At baseline and for up to 5 years
Distribution of Incidence of All Adverse Events (AEs)
Measured: Approximately 5 years
Distribution of Severity of All Adverse Events (AEs)
Measured: Approximately 5 years
Distribution of Management of All Adverse Events (AEs)
Measured: Approximately 5 years
European Quality of Life-5 Dimensions (EQ-5D)
Measured: At baseline and for up to 5 years
Lung Cancer Symptom Scale (LCSS)
Measured: At baseline and for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start9 Aug 2016
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 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
- Prospective
- Enrolment
- 868 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
- NCT02910999
- Sponsor's protocol ID
- CA209-580
- Acronym
- ENLARGE-Lung
- Status last verified
- May 2024
- First submitted
- 2 Sep 2016
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology (Stage IIIB/IV) After Prior Chemotherapy
- ClinicalTrials.gov ID
- NCT02910999
- Acronym / sponsor ID
- ENLARGE-Lung / CA209-580
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 868 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2016 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Sep 2016 (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.
This study intends to describe the real-life effectiveness and safety of nivolumab in advanced NSCLC patients in Germany, as well as the patient profile, pattern of use and the quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSCLC patients with squamous tumor histology | – | – |
| NSCLC patients with non-squamous tumor histology | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both cohorts will be recruited in different sites. Office-based as well as outpatient units in clinics.
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC, Stage IIIB/Stage IV
- Decision to initiate a treatment with Nivolumab for the first time already undertaken by physician
- Males and Females, ≥18 years of age
Key exclusion criteria (4 listed)
- Current primary diagnosis of a cancer other than advanced NSCLC. Example: A cancer other than NSCLC that requires systemic or other treatment.
- Pre-treatment with Nivolumab and/or Ipilimumab (pre-treatment with checkpoint-inhibitors other than Nivolumab and Ipilimumab, and Tyrosine Kinase Inhibitors(TKIs) is allowed)
- Current participation in an interventional clinical trial for treatment of NSCLC. (Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. For blinded studies, the treatment administered needs to be known)
- 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
Overall Survival (OS)
Time frame: Approximately 5 years
13 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Approximately 5 years
Overall Response Rate (ORR)
Time frame: Approximately 5 years
Best Overall Response Rate (BORR)
Time frame: Approximately 5 years
Best Overall Response (BOR)
Time frame: Approximately 5 years
Duration of Response (DOR)
Time frame: Approximately 5 years
Distribution of socio-demographic characteristics in adult patients diagnosed with advanced NSCLC
Time frame: At baseline and for up to 5 years
Distribution of clinical characteristics in adult patients diagnosed with advanced NSCLC
Time frame: At baseline and for up to 5 years
Distribution of treatment patterns in adult patients diagnosed with advanced NSCLC
Time frame: At baseline and for up to 5 years
Distribution of Incidence of All Adverse Events (AEs)
Time frame: Approximately 5 years
Distribution of Severity of All Adverse Events (AEs)
Time frame: Approximately 5 years
Distribution of Management of All Adverse Events (AEs)
Time frame: Approximately 5 years
European Quality of Life-5 Dimensions (EQ-5D)
Time frame: At baseline and for up to 5 years
Lung Cancer Symptom Scale (LCSS)
Time frame: At baseline and for up to 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 13 May 2024.
- BMS Clinical Trial InformationLink 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 Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 1 site in Germany.
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 4 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 13 May 2024. 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 Germany. 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: Approximately 5 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 13 May 2024.