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Completed

NCT Number: NCT05034926

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0002, Stróvolos, Cyprus

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

    This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.

  14. 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

    This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.

  15. 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

    This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.

  16. 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

    This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab.

  17. 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

    This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab.

  18. 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

    This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab.

  19. Frequencies of baseline participant and disease characteristics of interest

    Time frame: Up to approximately 59 months

    This refers to the overall study population and the SCC and NSCC subpopulation.

  20. Distribution of associations of baseline participant and disease characteristics with survival at 36 months post-treatment initiation

    Time frame: Up to 36 months

  21. Distribution of the number of nivolumab doses administered

    Time frame: Up to approximately 59 months

    This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.

  22. Distribution of the rate of dose modifications (including dose delays/withholdings)

    Time frame: Up to approximately 59 months

    This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.

  23. Distribution of the rate of permanent treatment discontinuation

    Time frame: Up to approximately 59 months

    This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.

  24. Distribution of the frequencies of reasons for dose modifications/discontinuations

    Time frame: Up to approximately 59 months

    This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.

  25. 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

    This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.

  26. Kaplan-Meier estimated time from nivolumab treatment initiation until discontinuation due to any reason

    Time frame: Up to approximately 59 months

    This refers to the overall study population, the SCC and NSCC subpopulations, and the subpopulations per line of nivolumab treatment.

  27. 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

  28. 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

  29. Time to resolution of high-grade (Grade 3 or higher) irAEs per AE category

    Time frame: Up to approximately 59 months

  30. Incidence of adverse events leading to nivolumab treatment permanent discontinuation, in the overall study population

    Time frame: Up to approximately 59 months

  31. Distribution of type of adverse events leading to nivolumab treatment permanent discontinuation, in the overall study population

    Time frame: Up to approximately 59 months

  32. Change in the total LCSS score in the overall study population

    Time frame: Up to approximately 59 months

  33. Change in the total ASBI score throughout the study observation period examined using longitudinal analysis

    Time frame: Up to approximately 59 months

  34. Change in the total Average Symptom Burden Index (ASBI) score, in the overall study population

    Time frame: Up to approximately 59 months

    In addition, change in the total ASBI score throughout the study observation period will be examined using longitudinal analysis

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

    in the overall study population

  40. 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

  41. Distribution of Emergency room attendances 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

  42. Distribution of Hospital outpatient visits 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

  43. 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

    Time frame: Up to approximately 59 months

  44. Distribution of Home visits by physicians, during the entire study observation period, in the overall study population

    Time frame: Up to approximately 59 months

  45. Distribution of Length of hospital stay, during the entire study observation period, in the overall study population

    Time frame: Up to approximately 59 months

  46. Distribution of Types and frequencies of medical procedures/interventions/diagnostic testing utilization, during the entire study observation period, in the overall study population

    Time frame: Up to approximately 59 months

  47. Distribution of Prescribed medications 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: LUCENCE

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2021
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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