Clinical trial NCT02910999: Real-Life Study With Nivolumab (BMS-936558) in Advanced NSCLC Patients After Prior Chemotherapy
Official title: A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology (Stage IIIB/IV) After Prior Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-09-22
Enrollment: 868
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Both cohorts will be recruited in different sites. Office-based as well as outpatient units in clinics.

Brief summary: This study intends to describe the real-life effectiveness and safety of nivolumab in advanced NSCLC patients in Germany, as well as the patient profile, pattern of use and the quality of life.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC, Stage IIIB/Stage IV
* Decision to initiate a treatment with Nivolumab for the first time already undertaken by physician
* Males and Females, ≥18 years of age

Exclusion Criteria:

* Current primary diagnosis of a cancer other than advanced NSCLC. Example: A cancer other than NSCLC that requires systemic or other treatment.
* Pre-treatment with Nivolumab and/or Ipilimumab (pre-treatment with checkpoint-inhibitors other than Nivolumab and Ipilimumab, and Tyrosine Kinase Inhibitors(TKIs) is allowed)
* Current participation in an interventional clinical trial for treatment of NSCLC. (Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. For blinded studies, the treatment administered needs to be known)

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Approximately 5 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Approximately 5 years
measure: Overall Response Rate (ORR)
timeFrame: Approximately 5 years
measure: Best Overall Response Rate (BORR)
timeFrame: Approximately 5 years
measure: Best Overall Response (BOR)
timeFrame: Approximately 5 years
measure: Duration of Response (DOR)
timeFrame: Approximately 5 years
measure: Distribution of socio-demographic characteristics in adult patients diagnosed with advanced NSCLC
timeFrame: At baseline and for up to 5 years
measure: Distribution of clinical characteristics in adult patients diagnosed with advanced NSCLC
timeFrame: At baseline and for up to 5 years
measure: Distribution of treatment patterns in adult patients diagnosed with advanced NSCLC
timeFrame: At baseline and for up to 5 years
measure: Distribution of Incidence of All Adverse Events (AEs)
timeFrame: Approximately 5 years
measure: Distribution of Severity of All Adverse Events (AEs)
timeFrame: Approximately 5 years
measure: Distribution of Management of All Adverse Events (AEs)
timeFrame: Approximately 5 years
measure: European Quality of Life-5 Dimensions (EQ-5D)
timeFrame: At baseline and for up to 5 years
measure: Lung Cancer Symptom Scale (LCSS)
timeFrame: At baseline and for up to 5 years
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: