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 (LIST)

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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer

• Study Type: Observational
• Enrollment (Anticipated): 698

Contacts and Locations

Study Locations

• France
  • Paris Cedex 5, France, 75248
    • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Cohort 1; Immuno-oncology (IO)-naïve patients
Cohort 2; IO-experienced patients for whom last IO discontinuation was not primarily related to IO-toxicity
Cohort 3; IO-experienced patients for whom last IO discontinuation was primarily due to IO-toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to treatment failure (TTF)	Up to 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Anticipated): September 15, 2025
• Study Completion (Anticipated): September 15, 2025

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Non Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CA209-7HX

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No