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

NCT05034926 | Completed

• 1 other identifier: CA209-7U9
• Study Type: observational
• Target: 212
• Locations: 2 countries
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• Proportion of participants surviving at the landmark timepoint of 12 months after the initiation of nivolumab treatment, in the overall study population

  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

  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

  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

  Up to 12 months

• Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment, among the SCC subpopulation

  Up to 24 months

• Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment, among the SCC subpopulation

  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

  Up to 12 months

• Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment, among the NSCC subpopulation

  Up to 24 months

Study Arms (1)

Cohort 1

Participants with locally advanced or metastatic (stage IIIB-IV) non-small cell lung cancer (NSCLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0002

Stróvolos, 2012, Cyprus

Location

Local Institution - 0001

Athens, 11527, Greece

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: September 5, 2021
• Study Start: October 7, 2020
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

GR (1); CY (1)