Clinical trial NCT06735781: Clinical Outcomes of Patients With Resectable Non-Small Cell Lung Cancer Receiving Neoadjuvant Nivolumab Plus Chemotherapy in France
Official title: Short-term Clinical Outcomes of Patients With Resectable Non-Small Cell Lung Cancer Receiving Nivolumab Plus Chemotherapy as Neoadjuvant Therapy in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Non-small cell lung cancer (NSCLC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-12-16
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: Rate of pathological complete response on date of surgery
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Secondary outcomes:
measure: Study population baseline demographics
timeFrame: Baseline
measure: Study population baseline clinical characteristics
timeFrame: Baseline
measure: Surgery rate
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Time from diagnosis to start of neoadjuvant treatment
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Average dose of nivolumab infusions
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Frequency of nivolumab infusions
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Duration of nivolumab treatment
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Type of chemotherapy received in combination with nivolumab treatment as neoadjuvant treatment
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Infusion setting (hospital or at home)
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Survival status
timeFrame: at 3, 6, 9, 12, 18, and 24 months (or until loss of follow-up, death, or end of study observation period (31 months))
measure: Subsequent treatments received after nivolumab treatment
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Disease progression/relapse status
timeFrame: At 3, 6, 9, 12, 18, and 24 months (or until loss of follow-up, death, or end of study observation period (31 months))
measure: Rate of major pathological response
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Adverse events
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Time to surgery from initial diagnosis
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Time to surgery from the first dose of neoadjuvant therapy
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Time to surgery from the last dose of neoadjuvant therapy
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Surgery type
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Duration of surgery
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Extent of surgical resection
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Rate of lymph node resection
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Type of surgery complications
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Length of hospital stay
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
measure: Reasons for not having surgery as indicated by the multi-disciplinary tumor board
timeFrame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Metz
country: France
facility: Hôpital Robert Schuman
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier
city: Paris
country: France
facility: Institute Curie
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Saint Anne
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: