Clinical trial · Observational
Real-world Data of Nivolumab in Pre-treated NSCLC
Real-world Data and Economic Evaluation of Nivolumab in Previously Treated NSCLC Patients in Greece
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Nivolumab is an approved treatment option for patients with previously treated advanced NSCLC, based on the survival benefit shown versus docetaxel in randomized phase III trials in second line. However, the profile of treatment and even patient outcomes are often different in routine clinical practice than in a clinical trial setting. Furthermore, the financial impact of an approved therapy is often largely unknown. This study will record the efficacy and tolerability of Nivolumab in previously treated patients with NSCLC and describe the treatment patterns and economic impact in real-world settings in Greece.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Description of real world clinical use of Nivolumab in pre-treated NSCLC patients
- timeFrame
- approximately 12 months
- description
- Real-world clinical use
- measure
- overall survival (OS)
- timeFrame
- approximately 12 months
- description
- Measured from time of initial treatment with nivolumab until date of death
Secondary outcomes (2)
- measure
- Objective Response Rate (ORR) as assessed by investigator
- timeFrame
- approximately 12 months
- description
- the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the total number of participants who received treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a diagnosis of advanced Squamous or Non-Squamous NSCLC (histologically or cytologically confirmed), who had relapsed after 1 prior platinum-based systemic treatment and who received treatment with nivolumab * nivolumab treatment received in participating HeCOG centres between October 2015 and November 2019 * Alive patients must have signed and dated the study approved written informed consent form in accordance with regulatory and institutional guidelines, obtained before any protocol-related procedures that are not part of normal patient care. Exclusion Criteria: * Alive patients who do not want to sign and date the study approved written informed consent form * Patients that participated in any other clinical trial prior or after nivolumab treatment
References
Publications (0)
Data not yet available