Resectable Non-small Cell Lung CancerNENINCT06169956
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
An observational study of Resectable Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 1 site in Germany.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Non-small Cell Lung Cancer
- What is being tested?
- Neoadjuvant nivolumab in combination with platinum-based chemotherapy
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 30 Nov 2023to 30 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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%
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
First line of the email MUST contain NCT # and Site #. contact
Germany1 site, 1 recruiting
- Recruiting
Klinikverbund Allgaeu
Kempten (Allgäu), Bavaria, 87439
Christian Schumann, Site 0001, +8315302382
About this study
Official title: 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
- Conditions
- Resectable Non-small Cell Lung Cancer
- Being tested
- Neoadjuvant nivolumab in combination with platinum-based chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant nivolumab in combination with platinum-based chemotherapyDrug
Neoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy | Not described Receives: Drug: Neoadjuvant nivolumab in combination with platinum-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Measured: Up to 5 years
Secondary outcomes (41)
Pathologic complete response (pCR) rate
Measured: Up to 5 years
Rate of major pathologic response (MPR)
Measured: Up to 5 years
Rate of partial pathologic response (pPR)
Measured: Up to 5 years
Rate of pathologic non-responder
Measured: Up to 5 years
Rate of tumor response
Classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)
Measured: Up to 5 years
Participant age
Measured: Baseline
Participant sex
Measured: Baseline
Participant insurance status
Measured: Baseline
Participant employment status
Measured: Baseline
Participant height in cm
Measured: Baseline
Participant weight in kg
Measured: Baseline
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
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
Measured: Baseline and up to 5 years
Participant medical history
Measured: Baseline
Participant history of smoking
Measured: Baseline
Participant concomitant treatments
Measured: Baseline and during neoadjuvant nivolumab plus platinum-based chemotherapy, up to 5 years
Participant subsequent treatments
Measured: Up to 5 years
Date of initial diagnosis of NSCLC
Measured: Baseline
Primary tumor assessed by histology subtype
Measured: Baseline
Tumor stage assessed by tumor node metastasis (TNM; stage IB-IIIA)
Measured: Baseline
Location of primary tumor
Measured: Baseline
Date of local relapse
Measured: Baseline to end of study, up to 5 years
Location of metastases
Measured: Baseline to end of study, up to 5 years
Date of metastatic diagnosis
Measured: 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)
Measured: 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)
Measured: Up to 5 years
Number of participants with abnormal hematology results
Measured: Up to 5 years
Number of participants with abnormal clinical chemistry results
Measured: Up to 5 years
Number of participants with abnormal biomarker results
Measured: Baseline to end of study, up to 5 years
Type of surgery
Measured: Up to 5 years
Completeness of resection assessed by residual tumor classification
R0: no residual tumor, R1: microscopic residual tumor, R2: macroscopic residual tumor, Rx: unknown
Measured: Up to 5 years
Number of participants with tumor resection
Measured: Up to 5 years
Extend of resection (R0/R1/R2)
Measured: Up to 5 years
Number of lymph nodes resected
Measured: Up to 5 years
Surgical approach
Thoracotomy, minimal invasive (video-assisted thoracoscopic surgery [VATS], robotic-assisted thoracic surgery [RATS]), minimal invasive to thoracotomy (conversion)
Measured: Up to 5 years
Length of hospital stay following surgery
Measured: From surgery to discharge from hospital, assessed up to 5 years
Incidence of adverse events
Measured: Up to 5 years
Severity of adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measured: 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
EQ-5D-3L summary index: 1 represents perfect health, 0 represents death, negative values represent health states considered worse than death
Measured: Up to 5 years
Time to next treatment
Time between end of primary treatment (neoadjuvant treatment + surgery + if needed by physician's assessment adjuvant therapy) to start of next treatment)
Measured: Up to 5 years
Dosing of nivolumab
Measured: Up to 5 years
Treatment regimens
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start30 Nov 2023
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169956
- Sponsor's protocol ID
- CA209-1210
- Acronym
- NENI
- Status last verified
- Apr 2024
- First submitted
- 17 Nov 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06169956
- Acronym / sponsor ID
- NENI / CA209-1210
- Conditions
- Resectable Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy | – | Drug: Neoadjuvant nivolumab in combination with platinum-based chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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%
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant nivolumab in combination with platinum-based chemotherapyNeoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics | Drug | Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy |
Primary outcome
Event-free survival
Time frame: Up to 5 years
41 secondary outcomes
Pathologic complete response (pCR) rate
Time frame: Up to 5 years
Rate of major pathologic response (MPR)
Time frame: Up to 5 years
Rate of partial pathologic response (pPR)
Time frame: Up to 5 years
Rate of pathologic non-responder
Time frame: Up to 5 years
Rate of tumor response
Time frame: Up to 5 years
Participant age
Time frame: Baseline
Participant sex
Time frame: Baseline
Participant insurance status
Time frame: Baseline
Participant employment status
Time frame: Baseline
Participant height in cm
Time frame: Baseline
Participant weight in kg
Time frame: Baseline
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Time frame: Baseline and up to 5 years
Participant medical history
Time frame: Baseline
Participant history of smoking
Time frame: Baseline
Participant concomitant treatments
Time frame: Baseline and during neoadjuvant nivolumab plus platinum-based chemotherapy, up to 5 years
Participant subsequent treatments
Time frame: Up to 5 years
Date of initial diagnosis of NSCLC
Time frame: Baseline
Primary tumor assessed by histology subtype
Time frame: Baseline
Tumor stage assessed by tumor node metastasis (TNM; stage IB-IIIA)
Time frame: Baseline
Location of primary tumor
Time frame: Baseline
Date of local relapse
Time frame: Baseline to end of study, up to 5 years
Location of metastases
Time frame: Baseline to end of study, up to 5 years
Date of metastatic diagnosis
Time frame: 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
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
Number of participants with abnormal hematology results
Time frame: Up to 5 years
Number of participants with abnormal clinical chemistry results
Time frame: Up to 5 years
Number of participants with abnormal biomarker results
Time frame: Baseline to end of study, up to 5 years
Type of surgery
Time frame: Up to 5 years
Completeness of resection assessed by residual tumor classification
Time frame: Up to 5 years
Number of participants with tumor resection
Time frame: Up to 5 years
Extend of resection (R0/R1/R2)
Time frame: Up to 5 years
Number of lymph nodes resected
Time frame: Up to 5 years
Surgical approach
Time frame: Up to 5 years
Length of hospital stay following surgery
Time frame: From surgery to discharge from hospital, assessed up to 5 years
Incidence of adverse events
Time frame: 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
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
Time to next treatment
Time frame: Up to 5 years
Dosing of nivolumab
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.