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

Lung Cancer Clinical Trial

— LIST  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04500535
• Other study ID #: CA209-7HX
• Status: Active, not recruiting
• Start date: September 28, 2020
• Est. completion date: September 15, 2025

Study information

• Verified date: May 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 698
• Est. completion date: September 15, 2025
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
France	Local Institution - 0001	Paris Cedex 5

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to treatment failure (TTF)		Up to 3 years
Secondary	Overall survival (OS)		Up to 3 years
Secondary	Progression-free survival (PFS)		Up to 3 years
Secondary	Time to next therapy (TTNT)		Up to 3 years
Secondary	Best overall response rate (BORR)		Up to 3 years
Secondary	Distribution of participant demographics characteristics: Age		Index date (treatment initiation date for each individual patient
Secondary	Distribution of participant demographics characteristics: Sex		Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: Smoking status		Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: ECOG at initial diagnosis and at nivolumab initiation		Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: Histology		Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: TNM classification	TNM=Tumor Nodes Metastases	Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: Location of metastases		Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: EGFR mutation	EGRF=Epidural Growth Factor Receptor	Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: ALK translocation	ALK= Anaplastic Lymphoma Kinase	Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: HER2 mutation	HER2=Human Epidermal Growth Factor Receptor 2	Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: BRAF mutation		Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: KRAS mutation		Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: ROS1 mutation		Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: MET mutation		Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: PD-L1 expression	PD-L1=Programmed Death Ligand 1	Index date (treatment initiation date for each individual patient)
Secondary	Distribution of clinical characteristics: PD-L1 expression on tumor or stromal cells	PD-L1=Programmed Death Ligand 1	Index date (treatment initiation date for each individual patient)
Secondary	Incidence of Adverse Drug Reactions		36 months after nivolumab treatment initiation
Secondary	Incidence of Seriousness criteria		36 months after nivolumab treatment initiation
Secondary	Incidence of Intensity/ Grade		36 months after nivolumab treatment initiation
Secondary	Incidence of AE duration		Follow-up period (Week 4 to Week 156)
Secondary	Incidence of Action taken regarding the BMS treatment		Follow-up period (Week 4 to Week 156)
Secondary	Incidence of Incidence rate		Follow-up period (Week 4 to Week 156)

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls