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

N/ACompletedNCT06735781

Bristol-Myers Squibb101 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

101

Conditions

Non-small Cell Lung Cancer (NSCLC)

Interventions

NivolumabDRUG

As prescribed by the treating clinician

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Centre François Baclesse

Caen, France

Centre Léon Bérard

Lyon, France

Hospices Civils de Lyon

Lyon, France

Hôpital Robert Schuman

Metz, France

Outcomes

Primary Outcomes

Rate of pathological complete response on date of surgery

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Secondary Outcomes

Study population baseline demographics

Time frame: Baseline

Study population baseline clinical characteristics

Time frame: Baseline

Surgery rate

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Time from diagnosis to start of neoadjuvant treatment

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Average dose of nivolumab infusions

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Frequency of nivolumab infusions

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Duration of nivolumab treatment

Time frame: 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

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Infusion setting (hospital or at home)

Data from ClinicalTrials.gov

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Institut du Cancer de Montpellier

Montpellier, France

Institute Curie

Paris, France

Hôpital d'Instruction des Armées Saint Anne

Toulon, France

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Survival status

Time frame: 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

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Disease progression/relapse status

Time frame: 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

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Adverse events

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Time to surgery from initial diagnosis

Time frame: 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

Time frame: 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

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Surgery type

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Duration of surgery

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Extent of surgical resection

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Rate of lymph node resection

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Type of surgery complications

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Length of hospital stay

Time frame: 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

Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)