Non-Small Cell Lung CancerLUCENCENCT05034926
A Study of Nivolumab in Participants With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology After Prior Chemotherapy Treated in Real World Settings in Greece and Cyprus
An observational study of Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 2 sites in 2 countries.
Trial summary
The purpose of this observational study is to estimate the overall survival (OS) rates in the overall study population treated with nivolumab in the second and third line setting in real world clinical practice in Greece and Cyprus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- Type of treatment
- Injection or infusion
- How many people
- 212 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Oct 2020to 31 Oct 2025
- 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: A total of 350 locally advanced/metastatic NSCLC patients who are eligible for participation in the study according to the inclusion and exclusion criteria are planned to be enrolled over a 24-month recruitment period by approximately 27 lung cancer specialists practicing in the public or private healthcare sector throughout Greece and Cyprus. Patients treated with nivolumab in the second and third line setting in real world clinical practice and who are eligible.
Who may be able to join
- Male or female adult Greek-speaking patients, of any race (residing in Greece or Cyprus), aged at least 18 years at time of initiation of nivolumab treatment.
- Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic (stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) with Squamous Cell Carcinoma (SCC) or Non-Squamous Cell Carcinoma (NSCC) histological subtype
- Initiated on second or third line treatment with nivolumab as monotherapy after prior chemotherapy as per the product's Summary of Product Characteristics (SmPC) prior to informed consent obtainment, and for whom therapy is ongoing and no more than one infusion has been administered from treatment initiation to obtaining the signed informed consent
- Decision to prescribe nivolumab treatment has been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study
- Provided signed informed consent for participating in the study and for collecting and analyzing medical data pertinent to the objectives of this study
Who cannot join
- Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
- Previously treated with nivolumab or other non-chemotherapy agents, with the exception of immune checkpoint inhibitors (anti-PD-1(Programmed cell death-1)/anti-PD-L1 (Programmed death-ligand 1) agent, other than nivolumab) administered in combination with chemotherapy
- Currently receiving or are planned to receive treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to nivolumab therapy initiation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multinational, Non-Interventional, Prospective Study of Nivolumab (BMS-936558) in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology After Prior Chemotherapy Treated in Real World Settings in Greece and Cyprus - The 'Lucence' Study
The purpose of this observational study is to estimate the overall survival (OS) rates in the overall study population treated with nivolumab in the second and third line setting in real world clinical practice in Greece and Cyprus. The study is descriptive in nature and is not planned to reject or affirm any formal statistical hypothesis.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- BMS-936558, Greece, Cyprus, Locally advanced, Metastatic NSCLC, Nivolumab, OPDIVO®, Prospective Study, Stage IIIb/IV, 2nd line treatment, 3rd line treatment, Observational study, LUCENCE study
- 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 |
|---|---|---|
| Cohort 1 | Participants with locally advanced or metastatic (stage IIIB-IV) non-small cell lung cancer (NSCLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants surviving at the landmark timepoint of 12 months after the initiation of nivolumab treatment, in the overall study population
Measured: Up to 12 months
Proportion of participants surviving at the landmark timepoint of 24 months after the initiation of nivolumab treatment, in the overall study population
Measured: Up to 24 months
Proportion of participants surviving at the landmark timepoint of 36 months after the initiation of nivolumab treatment, in the overall study population
Measured: Up to 36 months
Secondary outcomes (47)
Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment, among the Squamous Cell Carcinoma (SCC) subpopulation
Measured: Up to 12 months
Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment, among the SCC subpopulation
Measured: Up to 24 months
Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment, among the SCC subpopulation
Measured: Up to 36 months
Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment, among the Non-Squamous Cell Carcinoma (NSCC) subpopulation
Measured: Up to 12 months
Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment, among the NSCC subpopulation
Measured: Up to 24 months
Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment, among the NSCC subpopulation
Measured: Up to 36 months
Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment per line of nivolumab treatment
Measured: Up to 12 months
Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment per line of nivolumab treatment
Measured: Up to 24 months
Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment per line of nivolumab treatment
Measured: Up to 36 months
Proportion of participants who have not progressed or died from any cause at the landmark timepoint 12 months after the initiation of nivolumab treatment
Measured: Up to 12 months
Proportion of participants who have not progressed or died from any cause at the landmark timepoint 24 months after the initiation of nivolumab treatment
Measured: Up to 24 months
Proportion of participants who have not progressed or died from any cause at the landmark timepoint 36 months after the initiation of nivolumab treatment
Measured: Up to 36 months
Proportion of participants with an investigator-assessed best overall response (BOR) of either a confirmed complete response (CR) or confirmed PR (ORR rate) at the landmark timepoint of 12 months after the initiation of nivolumab treatment
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Measured: Up to 12 months
Proportion of participants with an investigator-assessed BOR of confirmed CR or PR or stable disease (SD) (DCR rate), at the landmark timepoint of 12 months after the initiation of nivolumab treatment
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Measured: Up to 12 months
Time from start of nivolumab treatment to the first documented investigator-assessed response (CR or PR) (i.e., TTR), among participants who achieved at least PR
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Measured: Up to approximately 59 months
Time from start of nivolumab treatment to best response (e.g., if a participant had both PR and CR, time to CR), among participants who achieved at least PR
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab.
Measured: Up to approximately 59 months
Kaplan-Meier estimated median time from first documented response (CR or PR) to the date of first documented progression or death (due to any cause in the absence of progression), among participants who achieved at least PR (i.e., DoR)
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab.
Measured: Up to approximately 59 months
Kaplan-Meier estimated median time from best response (e.g., if a patient had both PR and CR, time from CR) to the date of first documented progression or death (due to any cause in the absence of progression), among patients who achieved at least PR
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab.
Measured: Up to approximately 59 months
Frequencies of baseline participant and disease characteristics of interest
This refers to the overall study population and the SCC and NSCC subpopulation.
Measured: Up to approximately 59 months
Distribution of associations of baseline participant and disease characteristics with survival at 36 months post-treatment initiation
Measured: Up to 36 months
Distribution of the number of nivolumab doses administered
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Measured: Up to approximately 59 months
Distribution of the rate of dose modifications (including dose delays/withholdings)
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Measured: Up to approximately 59 months
Distribution of the rate of permanent treatment discontinuation
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Measured: Up to approximately 59 months
Distribution of the frequencies of reasons for dose modifications/discontinuations
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Measured: Up to approximately 59 months
Distribution of the types and frequencies of next treatment planned to be administered for NSCLC after nivolumab discontinuation
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Measured: Up to approximately 59 months
Kaplan-Meier estimated time from nivolumab treatment initiation until discontinuation due to any reason
This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.
Measured: Up to approximately 59 months
Distribution of exposure-adjusted incidence rate (EAIR), severity (grade), and management of the specified types of treatment-related AEs in the overall study population
Measured: Up to approximately 59 months
Time to onset of high-grade (Grade 3 or higher) immune-related adverse events (irAEs) per AE category
Measured: Up to approximately 59 months
Time to resolution of high-grade (Grade 3 or higher) irAEs per AE category
Measured: Up to approximately 59 months
Incidence of adverse events leading to nivolumab treatment permanent discontinuation, in the overall study population
Measured: Up to approximately 59 months
Distribution of type of adverse events leading to nivolumab treatment permanent discontinuation, in the overall study population
Measured: Up to approximately 59 months
Change in the total LCSS score in the overall study population
Measured: Up to approximately 59 months
Change in the total ASBI score throughout the study observation period examined using longitudinal analysis
Measured: Up to approximately 59 months
Change in the total Average Symptom Burden Index (ASBI) score, in the overall study population
In addition, change in the total ASBI score throughout the study observation period will be examined using longitudinal analysis
Measured: Up to approximately 59 months
Change in the individual domain scores from baseline to each post-baseline predefined timepoint in the overall study population
Measured: Up to approximately 59 months
Symptom improvement rate, at the post-baseline predefined timepoints, using the Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index (ASBI), in the overall study population
Measured: Up to approximately 59 months
Change in the EuroQol (EQ-5D) utility index score, from baseline at the post-baseline predefined timepoints, in the overall study population
Measured: Up to approximately 59 months
Change in the EuroQol Visual Analogue Scale (EQ-VAS) score, from baseline at the post-baseline predefined timepoints, in the overall study population
Measured: Up to approximately 59 months
Change in the proportion of participants in the five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) dimension levels (no problems, with problems) from baseline at the post-baseline predefined timepoints
in the overall study population
Measured: Up to approximately 59 months
Distribution of Person-time incidence rate (per 100 participant-weeks) of inpatient hospitalizations for the management of treatment-related AEs, during the entire study observation period, in the overall study population
Measured: Up to approximately 59 months
Distribution of Emergency room attendances for the management of treatment-related AEs, during the entire study observation period, in the overall study population
Measured: Up to approximately 59 months
Distribution of Hospital outpatient visits for the management of treatment-related AEs, during the entire study observation period, in the overall study population
Measured: Up to approximately 59 months
Distribution of Visits at office-based physicians for the management of treatment-related AEs, during the entire study observation period, in the overall study population
Measured: Up to approximately 59 months
Distribution of Home visits by physicians, during the entire study observation period, in the overall study population
Measured: Up to approximately 59 months
Distribution of Length of hospital stay, during the entire study observation period, in the overall study population
Measured: Up to approximately 59 months
Distribution of Types and frequencies of medical procedures/interventions/diagnostic testing utilization, during the entire study observation period, in the overall study population
Measured: Up to approximately 59 months
Distribution of Prescribed medications for the management of treatment-related AEs, during the entire study observation period, in the overall study population
Measured: Up to approximately 59 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start7 Oct 2020
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
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
- 212 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
- NCT05034926
- Sponsor's protocol ID
- CA209-7U9
- Acronym
- LUCENCE
- Status last verified
- Nov 2025
- First submitted
- 16 Aug 2021
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Non-Interventional, Prospective Study of Nivolumab (BMS-936558) in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology After Prior Chemotherapy Treated in Real World Settings in Greece and Cyprus - The 'Lucence' Study
- ClinicalTrials.gov ID
- NCT05034926
- Acronym / sponsor ID
- LUCENCE / CA209-7U9
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- BMS-936558, Greece, Cyprus, Locally advanced, Metastatic NSCLC, Nivolumab, OPDIVO®, Prospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 5 Sep 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.
The purpose of this observational study is to estimate the overall survival (OS) rates in the overall study population treated with nivolumab in the second and third line setting in real world clinical practice in Greece and Cyprus. The study is descriptive in nature and is not planned to reject or affirm any formal statistical hypothesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with locally advanced or metastatic (stage IIIB-IV) non-small cell lung cancer (NSCLC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 350 locally advanced/metastatic NSCLC patients who are eligible for participation in the study according to the inclusion and exclusion criteria are planned to be enrolled over a 24-month recruitment period by approximately 27 lung cancer specialists practicing in the public or private healthcare sector throughout Greece and Cyprus. Patients treated with nivolumab in the second and third line setting in real world clinical practice and who are eligible.
Key inclusion criteria (5 listed)
- Male or female adult Greek-speaking patients, of any race (residing in Greece or Cyprus), aged at least 18 years at time of initiation of nivolumab treatment.
- Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic (stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) with Squamous Cell Carcinoma (SCC) or Non-Squamous Cell Carcinoma (NSCC) histological subtype
- Initiated on second or third line treatment with nivolumab as monotherapy after prior chemotherapy as per the product's Summary of Product Characteristics (SmPC) prior to informed consent obtainment, and for whom therapy is ongoing and no more than one infusion has been administered from treatment initiation to obtaining the signed informed consent
- Decision to prescribe nivolumab treatment has been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study
- Provided signed informed consent for participating in the study and for collecting and analyzing medical data pertinent to the objectives of this study
Key exclusion criteria (3 listed)
- Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
- Previously treated with nivolumab or other non-chemotherapy agents, with the exception of immune checkpoint inhibitors (anti-PD-1(Programmed cell death-1)/anti-PD-L1 (Programmed death-ligand 1) agent, other than nivolumab) administered in combination with chemotherapy
- Currently receiving or are planned to receive treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to nivolumab therapy initiation
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 surviving at the landmark timepoint of 12 months after the initiation of nivolumab treatment, in the overall study population
Time frame: Up to 12 months
Proportion of participants surviving at the landmark timepoint of 24 months after the initiation of nivolumab treatment, in the overall study population
Time frame: Up to 24 months
Proportion of participants surviving at the landmark timepoint of 36 months after the initiation of nivolumab treatment, in the overall study population
Time frame: Up to 36 months
47 secondary outcomes
Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment, among the Squamous Cell Carcinoma (SCC) subpopulation
Time frame: Up to 12 months
Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment, among the SCC subpopulation
Time frame: Up to 24 months
Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment, among the SCC subpopulation
Time frame: Up to 36 months
Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment, among the Non-Squamous Cell Carcinoma (NSCC) subpopulation
Time frame: Up to 12 months
Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment, among the NSCC subpopulation
Time frame: Up to 24 months
Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment, among the NSCC subpopulation
Time frame: Up to 36 months
Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment per line of nivolumab treatment
Time frame: Up to 12 months
Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment per line of nivolumab treatment
Time frame: Up to 24 months
Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment per line of nivolumab treatment
Time frame: Up to 36 months
Proportion of participants who have not progressed or died from any cause at the landmark timepoint 12 months after the initiation of nivolumab treatment
Time frame: Up to 12 months
Proportion of participants who have not progressed or died from any cause at the landmark timepoint 24 months after the initiation of nivolumab treatment
Time frame: Up to 24 months
Proportion of participants who have not progressed or died from any cause at the landmark timepoint 36 months after the initiation of nivolumab treatment
Time frame: Up to 36 months
Proportion of participants with an investigator-assessed best overall response (BOR) of either a confirmed complete response (CR) or confirmed PR (ORR rate) at the landmark timepoint of 12 months after the initiation of nivolumab treatment
Time frame: Up to 12 months
Proportion of participants with an investigator-assessed BOR of confirmed CR or PR or stable disease (SD) (DCR rate), at the landmark timepoint of 12 months after the initiation of nivolumab treatment
Time frame: Up to 12 months
Time from start of nivolumab treatment to the first documented investigator-assessed response (CR or PR) (i.e., TTR), among participants who achieved at least PR
Time frame: Up to approximately 59 months
Time from start of nivolumab treatment to best response (e.g., if a participant had both PR and CR, time to CR), among participants who achieved at least PR
Time frame: Up to approximately 59 months
Kaplan-Meier estimated median time from first documented response (CR or PR) to the date of first documented progression or death (due to any cause in the absence of progression), among participants who achieved at least PR (i.e., DoR)
Time frame: Up to approximately 59 months
Kaplan-Meier estimated median time from best response (e.g., if a patient had both PR and CR, time from CR) to the date of first documented progression or death (due to any cause in the absence of progression), among patients who achieved at least PR
Time frame: Up to approximately 59 months
Frequencies of baseline participant and disease characteristics of interest
Time frame: Up to approximately 59 months
Distribution of associations of baseline participant and disease characteristics with survival at 36 months post-treatment initiation
Time frame: Up to 36 months
Distribution of the number of nivolumab doses administered
Time frame: Up to approximately 59 months
Distribution of the rate of dose modifications (including dose delays/withholdings)
Time frame: Up to approximately 59 months
Distribution of the rate of permanent treatment discontinuation
Time frame: Up to approximately 59 months
Distribution of the frequencies of reasons for dose modifications/discontinuations
Time frame: Up to approximately 59 months
Distribution of the types and frequencies of next treatment planned to be administered for NSCLC after nivolumab discontinuation
Time frame: Up to approximately 59 months
Kaplan-Meier estimated time from nivolumab treatment initiation until discontinuation due to any reason
Time frame: Up to approximately 59 months
Distribution of exposure-adjusted incidence rate (EAIR), severity (grade), and management of the specified types of treatment-related AEs in the overall study population
Time frame: Up to approximately 59 months
Time to onset of high-grade (Grade 3 or higher) immune-related adverse events (irAEs) per AE category
Time frame: Up to approximately 59 months
Time to resolution of high-grade (Grade 3 or higher) irAEs per AE category
Time frame: Up to approximately 59 months
Incidence of adverse events leading to nivolumab treatment permanent discontinuation, in the overall study population
Time frame: Up to approximately 59 months
Distribution of type of adverse events leading to nivolumab treatment permanent discontinuation, in the overall study population
Time frame: Up to approximately 59 months
Change in the total LCSS score in the overall study population
Time frame: Up to approximately 59 months
Change in the total ASBI score throughout the study observation period examined using longitudinal analysis
Time frame: Up to approximately 59 months
Change in the total Average Symptom Burden Index (ASBI) score, in the overall study population
Time frame: Up to approximately 59 months
Change in the individual domain scores from baseline to each post-baseline predefined timepoint in the overall study population
Time frame: Up to approximately 59 months
Symptom improvement rate, at the post-baseline predefined timepoints, using the Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index (ASBI), in the overall study population
Time frame: Up to approximately 59 months
Change in the EuroQol (EQ-5D) utility index score, from baseline at the post-baseline predefined timepoints, in the overall study population
Time frame: Up to approximately 59 months
Change in the EuroQol Visual Analogue Scale (EQ-VAS) score, from baseline at the post-baseline predefined timepoints, in the overall study population
Time frame: Up to approximately 59 months
Change in the proportion of participants in the five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) dimension levels (no problems, with problems) from baseline at the post-baseline predefined timepoints
Time frame: Up to approximately 59 months
Distribution of Person-time incidence rate (per 100 participant-weeks) of inpatient hospitalizations for the management of treatment-related AEs, during the entire study observation period, in the overall study population
Time frame: Up to approximately 59 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 24 Nov 2025.
- 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 Non-Small Cell 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 5 inclusion and 3 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 24 Nov 2025. 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 Cyprus, Greece. 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 surviving at the landmark timepoint of 12 months after the initiation of nivolumab treatment, in the overall study population (time frame: Up to 12 months). The study lists 3 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 24 Nov 2025.