An Observational Study to Evaluate Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy in Non-Metastatic Non-Small Cell Lung Cancer Participants in Germany (NENI)

April 17, 2024 updated by: Bristol-Myers Squibb

Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy for Non-Metastatic NSCLC: A German, Nationwide, Prospective, Observational, Multicenter Study in Patients Scheduled to Receive 3 Cycles Nivolumab in Combination With Platinum-Based Chemotherapy for Non-Metastatic (Stage and PD-L1 Expression According to Label) Non-Small Cell Lung Cancer

The purpose of this observational study is to collect and evaluate real-world data to assess the effectiveness of neoadjuvant nivolumab when given in combination with platinum-based chemotherapy in participants with early-stage, resectable non-small cell lung cancer (NSCLC) in Germany

Study Overview

Status

Status

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

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 (Estimated)

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.
400

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • Germany
    • Bayern
      • Kempten, Bayern, Germany, 87439
        • Recruiting
        • Klinikverbund Allgaeu
        • Contact:
          • Christian Schumann, Site 0001
          • Phone Number: +8315302382

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

No

Sampling Method

Probability Sample

Study Population

Adult participants aged ≥ 18 years of age or older who are diagnosed with resectable non-small cell lung cancer at high risk of recurrence and whose tumors have programmed death-ligand 1 (PD-L1) expression ≥ 1%

Description

Inclusion Criteria:

  • Aged 18 years or older
  • Diagnosis of non-metastatic non-small cell lung cancer with tumor Programmed death-ligand 1 (PD-L1) expression level of 1% or more (tumor proportion score (TPS); according to label approved in the European Union)
  • Decision to initiate a neoadjuvant treatment with nivolumab plus platinum-based chemotherapy for treatment of non-small cell lung cancer according to current Summary of product characteristics and independent of the study
  • Willing to complete patient-reported outcome questionnaires and sufficient understanding of the German language
  • Signed written informed consent
  • Other criteria according to current Summary of product characteristics

Exclusion Criteria:

  • Current primary diagnosis of cancer other than non-small cell lung cancer that requires systemic or other treatment
  • Other contraindications according to current Summary of product characteristics

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.
Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy
Drug: Neoadjuvant nivolumab in combination with platinum-based chemotherapy
Neoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics

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
Event-free survival
Time Frame: Up to 5 years
Up to 5 years

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
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 5 years
Up to 5 years
Pathologic complete response (pCR) rate
Time Frame: Up to 5 years
Up to 5 years
Rate of major pathologic response (MPR)
Time Frame: Up to 5 years
Up to 5 years
Rate of partial pathologic response (pPR)
Time Frame: Up to 5 years
Up to 5 years
Rate of pathologic non-responder
Time Frame: Up to 5 years
Up to 5 years
Rate of tumor response
Time Frame: Up to 5 years
Classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)
Up to 5 years
Participant age
Time Frame: Baseline
Baseline
Participant sex
Time Frame: Baseline
Baseline
Participant insurance status
Time Frame: Baseline
Baseline
Participant employment status
Time Frame: Baseline
Baseline
Participant height in cm
Time Frame: Baseline
Baseline
Participant weight in kg
Time Frame: Baseline
Baseline
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Time Frame: Baseline and up to 5 years
ECOG-PS score of 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS score of 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS score of 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours. ECOG-PS score of 3 = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. ECOG-PS score of 4 = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. ECOG-PS score of 5 = Dead
Baseline and up to 5 years
Participant medical history
Time Frame: Baseline
Baseline
Participant history of smoking
Time Frame: Baseline
Baseline
Participant concomitant treatments
Time Frame: Baseline and during neoadjuvant nivolumab plus platinum-based chemotherapy, up to 5 years
Baseline and during neoadjuvant nivolumab plus platinum-based chemotherapy, up to 5 years
Participant subsequent treatments
Time Frame: Up to 5 years
Up to 5 years
Date of initial diagnosis of NSCLC
Time Frame: Baseline
Baseline
Primary tumor assessed by histology subtype
Time Frame: Baseline
Baseline
Tumor stage assessed by tumor node metastasis (TNM; stage IB-IIIA)
Time Frame: Baseline
Baseline
Location of primary tumor
Time Frame: Baseline
Baseline
Date of local relapse
Time Frame: Baseline to end of study, up to 5 years
Baseline to end of study, up to 5 years
Location of metastases
Time Frame: Baseline to end of study, up to 5 years
Baseline to end of study, up to 5 years
Date of metastatic diagnosis
Time Frame: Baseline to end of study, up to 5 years
Baseline to end of study, up to 5 years
Tumor size assessed by medical imaging using x-rays, computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, bone scintigraphy, positron emission tomography-computed tomography (PET- CT)
Time Frame: Up to 5 years
Up to 5 years
Tumor location assessed by medical imaging using x-rays, computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, bone scintigraphy, positron emission tomography-computed tomography (PET- CT)
Time Frame: Up to 5 years
Up to 5 years
Number of participants with abnormal hematology results
Time Frame: Up to 5 years
Up to 5 years
Number of participants with abnormal clinical chemistry results
Time Frame: Up to 5 years
Up to 5 years
Number of participants with abnormal biomarker results
Time Frame: Baseline to end of study, up to 5 years
Baseline to end of study, up to 5 years
Type of surgery
Time Frame: Up to 5 years
Up to 5 years
Completeness of resection assessed by residual tumor classification
Time Frame: Up to 5 years
R0: no residual tumor, R1: microscopic residual tumor, R2: macroscopic residual tumor, Rx: unknown
Up to 5 years
Number of participants with tumor resection
Time Frame: Up to 5 years
Up to 5 years
Extend of resection (R0/R1/R2)
Time Frame: Up to 5 years
Up to 5 years
Number of lymph nodes resected
Time Frame: Up to 5 years
Up to 5 years
Surgical approach
Time Frame: Up to 5 years
Thoracotomy, minimal invasive (video-assisted thoracoscopic surgery [VATS], robotic-assisted thoracic surgery [RATS]), minimal invasive to thoracotomy (conversion)
Up to 5 years
Length of hospital stay following surgery
Time Frame: From surgery to discharge from hospital, assessed up to 5 years
From surgery to discharge from hospital, assessed up to 5 years
Severity of adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Time Frame: Up to 5 years
Up to 5 years
Patient-reported health-related Quality of Life assessed by using the validated European Quality of Life 5 Dimension 3 Level (EQ-5D-3L) questionnaire
Time Frame: Up to 5 years
EQ-5D-3L summary index: 1 represents perfect health, 0 represents death, negative values represent health states considered worse than death
Up to 5 years
Time to next treatment
Time Frame: Up to 5 years
Time between end of primary treatment (neoadjuvant treatment + surgery + if needed by physician's assessment adjuvant therapy) to start of next treatment)
Up to 5 years
Dosing of nivolumab
Time Frame: Up to 5 years
Up to 5 years
Treatment regimens
Time Frame: Up to 5 years
Up to 5 years

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.
November 30, 2023

Primary Completion (Estimated)

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.
September 30, 2030

Study Completion (Estimated)

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.
September 30, 2030

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).
November 17, 2023

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 5, 2023

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.
December 14, 2023

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.
April 18, 2024

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.
April 17, 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.
April 1, 2024

More Information

Terms related to this study

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.
  • CA209-1210

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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