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

NCT06735781 | Completed FDA Drug

• 1 other identifier: CA209-1512
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Non-small cell lung cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• 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)

Study Arms (1)

Neoadjuvant nivolumab plus chemotherapy treatment

Drug: Nivolumab

Interventions

Nivolumab DRUG

As prescribed by the treating clinician

Neoadjuvant nivolumab plus chemotherapy treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (7)

Centre François Baclesse

Caen, France

Location

Centre Léon Bérard

Lyon, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Hôpital Robert Schuman

Metz, France

Location

Institut du Cancer de Montpellier

Montpellier, France

Location

Institute Curie

Paris, France

Location

Hôpital d'Instruction des Armées Saint Anne

Toulon, France

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: September 5, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)