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

Completed

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Drug: Nivolumab

• Registration Number: NCT06735781
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-09-05
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neoadjuvant nivolumab plus chemotherapy treatment	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Surgery rate	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)
Duration of nivolumab treatment	Up to 31 months (until loss of follow-up, death, or end of study observation period)
Study population baseline demographics	Baseline
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)
Study population baseline clinical characteristics	Baseline
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)
Extent of surgical resection	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)
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)
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)

Trial Locations

Locations (7)

Centre François Baclesse; 🇫🇷 Caen, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Institut du Cancer de Montpellier; 🇫🇷 Montpellier, France

Hôpital Robert Schuman; 🇫🇷 Metz, France

Institute Curie; 🇫🇷 Paris, France

Hôpital d'Instruction des Armées Saint Anne; 🇫🇷 Toulon, France