Clinical trial NCT04713462: Real-world Data of Nivolumab in Pre-treated NSCLC
Official title: Real-world Data and Economic Evaluation of Nivolumab in Previously Treated NSCLC Patients in Greece
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced NSCLC who had received nivolumab as 2nd line and beyond, between October 2015 and November 2019, in HeCOG clinical centres in Greece, were enrolled.

Brief summary: 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.

Detailed description: Patients with advanced NSCLC who had received nivolumab as 2nd line and beyond, between October 2015 and November 2019, in HeCOG clinical centres in Greece, were enrolled. Information regarding detailed patient and treatment characteristics including post-nivolumab therapies, efficacy, and safety data of nivolumab treatment and additionally data on costs and other economic values are collected, analysed and compared with historical data in order to describe the real-world patterns of Nivolumab use in 2nd line NSCLC therapy in Greece.

Eligibility criteria: 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

Primary outcomes:
measure: Description of real world clinical use of Nivolumab in pre-treated NSCLC patients
timeFrame: approximately 12 months
measure: overall survival (OS)
timeFrame: approximately 12 months
Secondary outcomes:
measure: Objective Response Rate (ORR) as assessed by investigator
timeFrame: approximately 12 months
measure: Cost-effectiveness
timeFrame: approximately 12 months
Other outcomes:
Locations:
Study officials:
References: