Non-small Cell Lung Cancer (NSCLC)NCT06735781
Clinical Outcomes of Patients With Resectable Non-Small Cell Lung Cancer Receiving Neoadjuvant Nivolumab Plus Chemotherapy in France
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 7 sites in France.
Trial summary
The purpose of this study is to evaluate real-world effectiveness of neoadjuvant nivolumab plus chemotherapy in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Nivolumab
- How many people
- 101 participants
- Where
- 7 sitesFrance
- Study dates
- 5 Sep 2024to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre François Baclesse
Caen
Centre Léon Bérard
Lyon
Hospices Civils de Lyon
Lyon
Hôpital Robert Schuman
Metz
Institut du Cancer de Montpellier
Montpellier
Institute Curie
Paris
Hôpital d'Instruction des Armées Saint Anne
Toulon
About this study
Official title: 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.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Nivolumab
- Keywords
- Non-small cell lung cancer (NSCLC)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
As prescribed by the treating clinician
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant nivolumab plus chemotherapy treatment | Not described Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pathological complete response on date of surgery
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Secondary outcomes (24)
Study population baseline demographics
Measured: Baseline
Study population baseline clinical characteristics
Measured: Baseline
Surgery rate
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Time from diagnosis to start of neoadjuvant treatment
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Average dose of nivolumab infusions
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Frequency of nivolumab infusions
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Duration of nivolumab treatment
Measured: 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
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Infusion setting (hospital or at home)
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Survival status
Measured: 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
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Disease progression/relapse status
Measured: 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
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Adverse events
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Time to surgery from initial diagnosis
Measured: 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
Measured: 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
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Surgery type
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Duration of surgery
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Extent of surgical resection
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Rate of lymph node resection
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Type of surgery complications
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Length of hospital stay
Measured: 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
Measured: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start5 Sep 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies 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
- Retrospective
- Enrolment
- 101 participants (actual)
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
- NCT06735781
- Sponsor's protocol ID
- CA209-1512
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Clinical Outcomes of Patients With Resectable Non-Small Cell Lung Cancer Receiving Nivolumab Plus Chemotherapy as Neoadjuvant Therapy in France
- ClinicalTrials.gov ID
- NCT06735781
- Acronym / sponsor ID
- CA209-1512
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- Non-small cell lung cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 16 Dec 2024 (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 study is to evaluate real-world effectiveness of neoadjuvant nivolumab plus chemotherapy in France.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant nivolumab plus chemotherapy treatment | – | Drug: Nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| NivolumabAs prescribed by the treating clinician | Drug | Neoadjuvant nivolumab plus chemotherapy treatment |
Primary outcome
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)
24 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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer (NSCLC)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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. This study is not recruiting at the moment.
Bristol Myers Squibb study director
Bristol-Myers Squibb
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 7 sites in France.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 16 Dec 2024.