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Completed

NCT Number: 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

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

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Paris, 75248, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to treatment failure (TTF)

    Time frame: Up to 3 years

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Up to 3 years

  2. Progression-free survival (PFS)

    Time frame: Up to 3 years

  3. Time to next therapy (TTNT)

    Time frame: Up to 3 years

  4. Best overall response rate (BORR)

    Time frame: Up to 3 years

  5. Distribution of participant demographics characteristics: Age

    Time frame: Index date (treatment initiation date for each individual patient

  6. Distribution of participant demographics characteristics: Sex

    Time frame: Index date (treatment initiation date for each individual patient)

  7. Distribution of clinical characteristics: Smoking status

    Time frame: Index date (treatment initiation date for each individual patient)

  8. Distribution of clinical characteristics: ECOG at initial diagnosis and at nivolumab initiation

    Time frame: Index date (treatment initiation date for each individual patient)

  9. Distribution of clinical characteristics: Histology

    Time frame: Index date (treatment initiation date for each individual patient)

  10. Distribution of clinical characteristics: TNM classification

    Time frame: Index date (treatment initiation date for each individual patient)

    TNM=Tumor Nodes Metastases

  11. Distribution of clinical characteristics: Location of metastases

    Time frame: Index date (treatment initiation date for each individual patient)

  12. Distribution of clinical characteristics: EGFR mutation

    Time frame: Index date (treatment initiation date for each individual patient)

    EGRF=Epidural Growth Factor Receptor

  13. Distribution of clinical characteristics: ALK translocation

    Time frame: Index date (treatment initiation date for each individual patient)

    ALK= Anaplastic Lymphoma Kinase

  14. Distribution of clinical characteristics: HER2 mutation

    Time frame: Index date (treatment initiation date for each individual patient)

    HER2=Human Epidermal Growth Factor Receptor 2

  15. Distribution of clinical characteristics: BRAF mutation

    Time frame: Index date (treatment initiation date for each individual patient)

  16. Distribution of clinical characteristics: KRAS mutation

    Time frame: Index date (treatment initiation date for each individual patient)

  17. Distribution of clinical characteristics: ROS1 mutation

    Time frame: Index date (treatment initiation date for each individual patient)

  18. Distribution of clinical characteristics: MET mutation

    Time frame: Index date (treatment initiation date for each individual patient)

  19. Distribution of clinical characteristics: PD-L1 expression

    Time frame: Index date (treatment initiation date for each individual patient)

    PD-L1=Programmed Death Ligand 1

  20. Distribution of clinical characteristics: PD-L1 expression on tumor or stromal cells

    Time frame: Index date (treatment initiation date for each individual patient)

    PD-L1=Programmed Death Ligand 1

  21. Incidence of Adverse Drug Reactions

    Time frame: 36 months after nivolumab treatment initiation

  22. Incidence of Seriousness criteria

    Time frame: 36 months after nivolumab treatment initiation

  23. Incidence of Intensity/ Grade

    Time frame: 36 months after nivolumab treatment initiation

  24. Incidence of AE duration

    Time frame: Follow-up period (Week 4 to Week 156)

  25. Incidence of Action taken regarding the BMS treatment

    Time frame: Follow-up period (Week 4 to Week 156)

  26. Incidence of Incidence rate

    Time frame: Follow-up period (Week 4 to Week 156)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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)

Acronym: LIST

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2020
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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