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

Active, not recruiting

• Conditions: Lung Cancer

• Registration Number: NCT04500535
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-05
• Study Start: 2020-09-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22
• Primary Completion: 2025-09-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 698

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to treatment failure (TTF)	Up to 3 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution - 0001; 🇫🇷 Paris Cedex 5, France