Clinical Outcomes of Patients With Resectable Non-Small Cell Lung Cancer Receiving Neoadjuvant Nivolumab Plus Chemotherapy in France

Short-term Clinical Outcomes of Patients With Resectable Non-Small Cell Lung Cancer Receiving Nivolumab Plus Chemotherapy as Neoadjuvant Therapy in France

The purpose of this study is to evaluate real-world effectiveness of neoadjuvant nivolumab plus chemotherapy in France.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Nivolumab

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Centre Francois Baclesse
  • Lyon, France
    • Hospices Civils de Lyon
  • Lyon, France
    • Centre Leon Berard
  • Metz, France
    • Hopital Robert Schuman
  • Montpellier, France
    • Institut du Cancer de Montpellier
  • Paris, France
    • Institute Curie
  • Toulon, France
    • Hôpital d'Instruction des Armées Saint Anne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study population will include adults that have been diagnosed with resectable non-small cell lung cancer who initiated nivolumab plus chemotherapy as neoadjuvant therapy outside of clinical trial setting in France

Description

Inclusion Criteria:

• Having a diagnosis of resectable non-small cell lung cancer (NSCLC)
• Being 18 years or above at the time of their NSCLC diagnosis
• Having initiated a neoadjuvant treatment with nivolumab and chemotherapy outside a clinical trial
• Being indexed in the site database
• Being followed at the site for at least 5 months, except for patients with a record of death

Exclusion Criteria:

• Having any primary tumor other than NSCLC on or before the date of NSCLC diagnosis that required a treatment ending less than 12-months before the nivolumab plus chemotherapy neoadjuvant treatment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neoadjuvant nivolumab plus chemotherapy treatment	Drug: Nivolumab; As prescribed by the treating clinician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of pathological complete response on date of surgery	Up to 31 months (until loss of follow-up, death, or end of study observation period)

Secondary Outcome Measures

Outcome Measure	Time Frame
Study population baseline demographics	Baseline
Study population baseline clinical characteristics	Baseline
Surgery rate	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Time from diagnosis to start of neoadjuvant treatment	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Average dose of nivolumab infusions	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Frequency of nivolumab infusions	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Duration of nivolumab treatment	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Type of chemotherapy received in combination with nivolumab treatment as neoadjuvant treatment	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Infusion setting (hospital or at home)	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Survival status	at 3, 6, 9, 12, 18, and 24 months (or until loss of follow-up, death, or end of study observation period (31 months))
Subsequent treatments received after nivolumab treatment	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Disease progression/relapse status	At 3, 6, 9, 12, 18, and 24 months (or until loss of follow-up, death, or end of study observation period (31 months))
Rate of major pathological response	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Adverse events	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Time to surgery from initial diagnosis	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Time to surgery from the first dose of neoadjuvant therapy	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Time to surgery from the last dose of neoadjuvant therapy	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Surgery type	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Duration of surgery	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Extent of surgical resection	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Rate of lymph node resection	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Type of surgery complications	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Length of hospital stay	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Reasons for not having surgery as indicated by the multi-disciplinary tumor board	Up to 31 months (until loss of follow-up, death, or end of study observation period)

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 5, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer (NSCLC)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Nivolumab
• Other Study ID Numbers: CA209-1512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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