Clinical trial NCT04500535: A Study of Participants With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment by Lung Initiative on Sequence Therapy
Official title: A Multi-Center, Longitudinal, Prospective, Observational, Multi-Cohort Study of Patients With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment (LIST, Lung Initiative on Sequence Therapy)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Cancer
Keywords: Non Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-08-05
Enrollment: 698
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population will be constituted using multistage sampling, in which physicians (pulmonologists and/or oncologists) from eligible hospitals are to identify and recruit the participants. Eligible hospitals will be selected among PMSI sites (national hospital discharge database) and only hospitals with a minimum of 40 patients treated for lung cancer and with chemotherapy in 2018 will be considered to ensure sufficient enrollment.

Brief summary: The purpose of this trial is to describe the following, for each cohort, in real world conditions in France:

* The characteristics and treatment sequence of patients treated with nivolumab
* The effectiveness of nivolumab treatment
* The safety profile of nivolumab
* Treatment patterns (e.g. duration of treatment, subsequent treatments) of nivolumab
* The patient-reported outcomes (PRO) in patients treated with nivolumab, at baseline and during follow up using the EuroQoL-5D-3L


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

Inclusion Criteria:

* Pathologically confirmed diagnosis of advanced NSCLC
* Whose physician has already decided to initiate a treatment with nivolumab for the treatment of advanced NSCLC according to the European label
* Previously treated with at least one prior chemotherapy- containing regimen

Exclusion Criteria:

* Participants taking part in an interventional study for lung cancer treatment for which nivolumab is one of the investigational drugs
* Participants with a diagnosis of another primary cancer within the past five years
* Participants receiving IO within 12 weeks prior to nivolumab first infusion in the context of the present study

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Time to treatment failure (TTF)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 3 years
measure: Progression-free survival (PFS)
timeFrame: Up to 3 years
measure: Time to next therapy (TTNT)
timeFrame: Up to 3 years
measure: Best overall response rate (BORR)
timeFrame: Up to 3 years
measure: Distribution of participant demographics characteristics: Age
timeFrame: Index date (treatment initiation date for each individual patient
measure: Distribution of participant demographics characteristics: Sex
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: Smoking status
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: ECOG at initial diagnosis and at nivolumab initiation
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: Histology
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: TNM classification
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: Location of metastases
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: EGFR mutation
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: ALK translocation
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: HER2 mutation
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: BRAF mutation
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: KRAS mutation
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: ROS1 mutation
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: MET mutation
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: PD-L1 expression
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: PD-L1 expression on tumor or stromal cells
timeFrame: Index date (treatment initiation date for each individual patient)
measure: Incidence of Adverse Drug Reactions
timeFrame: 36 months after nivolumab treatment initiation
measure: Incidence of Seriousness criteria
timeFrame: 36 months after nivolumab treatment initiation
measure: Incidence of Intensity/ Grade
timeFrame: 36 months after nivolumab treatment initiation
measure: Incidence of AE duration
timeFrame: Follow-up period (Week 4 to Week 156)
measure: Incidence of Action taken regarding the BMS treatment
timeFrame: Follow-up period (Week 4 to Week 156)
measure: Incidence of Incidence rate
timeFrame: Follow-up period (Week 4 to Week 156)
Other outcomes:
Locations:
city: Paris Cedex 5
country: France
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: