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

NCT04500535 | Completed DMC

• 1 other identifier: CA209-7HX
• Study Type: observational
• Target: 535
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer

Keywords

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure (TTF)

  Up to 3 years

Secondary Outcomes (26)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Paris, 75248, France

Location

Related Publications (1)

• Godbert B, Gobbini E, Decroisette C, Lena H, Khalife Y, Brellier F, Fleuriet A, Zysman M, Egenod T, Moro Sibilot D, Girard N. Real-World Use and Immunotherapy Rechallenge Outcomes with Nivolumab in Advanced Non-small Cell Lung Cancer in France: Interim Results of the LIST Study. Oncol Ther. 2025 Dec;13(4):1071-1086. doi: 10.1007/s40487-025-00381-z. Epub 2025 Sep 14.

  PMID: 40946253 DERIVED

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 5, 2020
• Study Start: September 28, 2020
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

FR (1)