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

December 11, 2024 updated by: Bristol-Myers Squibb

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Neoadjuvant nivolumab plus chemotherapy treatment
Drug: Nivolumab
As prescribed by the treating clinician

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Up to 31 months (until loss of follow-up, death, or end of study observation period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Study population baseline demographics
Time Frame: Baseline
Baseline
Study population baseline clinical characteristics
Time Frame: Baseline
Baseline
Surgery rate
Time Frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
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)
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)
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)
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)
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)
Up to 31 months (until loss of follow-up, death, or end of study observation period)
Infusion setting (hospital or at home)
Time Frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
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))
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)
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))
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Up to 31 months (until loss of follow-up, death, or end of study observation period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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