Carcinoma, Non-Small-Cell LungFINNNCT04794010
A Study in Participants With First-Line Nivolumab Plus Ipilimumb Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer
An observational study of Carcinoma, Non-Small-Cell Lung, run by Bristol-Myers Squibb at 1 site in Germany.
Trial summary
The purpose of the study is to collect real-life data during the early post-market authorization approval period in Germany. The study aims at describing the outcomes, patient characteristics, safety profile, treatment patterns and patient-reported Quality of Life of first-line treatment with nivolumab plus ipilimumab… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 825 participants
- Where
- 1 siteGermany
- Study dates
- 22 Dec 2020to 22 Dec 2027
- 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: It is planned to include 825 patients at 100 sites in Germany in this observational study from marketing authorization by the European Medicines Agency (EMA) onwards. The planned recruitment phase is approximately 24 months, the planned follow-up phase 60 months from the day of nivolumab plus ipilimumab plus two cycles of chemotherapy initiation (D0).
Who may be able to join
- Diagnosis of stage IV Non-Small Cell Lung Cancer (NSCLC) (histologically or cytologically confirmed stage), without known Epidermal Growth Factor Receptor (EGFR)- or Anaplastic Lymphoma Kinase (ALK)-alterations (according to label approved by EU)
- Decision to initiate a first-line treatment with nivolumab plus ipilimumab combined with two cycles of chemotherapy for the treatment of NSCLC according to the German label has been made independently of the study
Who cannot join
- Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
- Participants with known EGFR- or ALK-alterations
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A German, Nationwide, Prospective, Observational, Multicenter Study in Patients With First-line Nivolumab Plus Ipilimumab Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer
The purpose of the study is to collect real-life data during the early post-market authorization approval period in Germany.
The study aims at describing the outcomes, patient characteristics, safety profile, treatment patterns and patient-reported Quality of Life of first-line treatment with nivolumab plus ipilimumab in combination with two cycles of chemo therapy in participants with confirmed stage IV Non-Small Cell Lung Cancer (NSCLC).
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Nivolumab, Ipilimumab, Chemotherapy, Metastatic
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with Metastatic Non-Small Cell Lung Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: Up to 5 years
Secondary outcomes (14)
Overall Survival (OS) according to subgroups of interest
Measured: Up to 5 years
Progression-free survival (PFS)
Measured: Up to 5 years
Duration of treatment
Measured: Up to 5 years
Distribution of socio-demographic characteristics of participants
Age, Sex, Ethnicity, Height, Weight and BMI
Measured: At Baseline
Distribution of clinical characteristics of participants
Histology subtype, Tumor stage, Location or primary tumor and Location of metastases
Measured: At Baseline
Description of participant-reported outcomes (PROs) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires
Measured: Up to 5 years
Description of participant-reported outcomes (PROs) of participants using Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
Measured: Up to 5 years
Management of AEs: Treatment of AEs
Measured: Up to 5 years
Management of AEs: Date of occurrence of AE
Measured: Up to 5 years
Management of AEs: Start of treatment
Measured: Up to 5 years
Treatment Patterns: Previous therapies
Measured: Up to 5 years
Treatment Patterns: Subsequent therapies
Measured: Up to 5 years
Treatment patterns: Concomitant medication
Measured: Up to 5 years
Treatment patterns : Management of treatment-related adverse events [AEs], previous and subsequent therapies
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 posted11 Mar 2021
- Study start22 Dec 2020
- Primary completion22 Dec 2027 (estimated)
- Study completion22 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- 825 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
- NCT04794010
- Sponsor's protocol ID
- CA209-7MA
- Acronym
- FINN
- Status last verified
- Dec 2024
- First submitted
- 10 Mar 2021
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A German, Nationwide, Prospective, Observational, Multicenter Study in Patients With First-line Nivolumab Plus Ipilimumab Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04794010
- Acronym / sponsor ID
- FINN / CA209-7MA
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Nivolumab, Ipilimumab, Chemotherapy, Metastatic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 825 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 22 Dec 2027 (estimated)
- Study completion
- 22 Dec 2027 (estimated)
- First posted
- 11 Mar 2021 (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 the study is to collect real-life data during the early post-market authorization approval period in Germany.
The study aims at describing the outcomes, patient characteristics, safety profile, treatment patterns and patient-reported Quality of Life of first-line treatment with nivolumab plus ipilimumab in combination with two cycles of chemo therapy in participants with confirmed stage IV Non-Small Cell Lung Cancer (NSCLC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with Metastatic Non-Small Cell Lung Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to include 825 patients at 100 sites in Germany in this observational study from marketing authorization by the European Medicines Agency (EMA) onwards. The planned recruitment phase is approximately 24 months, the planned follow-up phase 60 months from the day of nivolumab plus ipilimumab plus two cycles of chemotherapy initiation (D0).
Key inclusion criteria (2 listed)
- Diagnosis of stage IV Non-Small Cell Lung Cancer (NSCLC) (histologically or cytologically confirmed stage), without known Epidermal Growth Factor Receptor (EGFR)- or Anaplastic Lymphoma Kinase (ALK)-alterations (according to label approved by EU)
- Decision to initiate a first-line treatment with nivolumab plus ipilimumab combined with two cycles of chemotherapy for the treatment of NSCLC according to the German label has been made independently of the study
Key exclusion criteria (3 listed)
- Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
- Participants with known EGFR- or ALK-alterations
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: Up to 5 years
14 secondary outcomes
Overall Survival (OS) according to subgroups of interest
Time frame: Up to 5 years
Progression-free survival (PFS)
Time frame: Up to 5 years
Duration of treatment
Time frame: Up to 5 years
Distribution of socio-demographic characteristics of participants
Time frame: At Baseline
Distribution of clinical characteristics of participants
Time frame: At Baseline
Description of participant-reported outcomes (PROs) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires
Time frame: Up to 5 years
Description of participant-reported outcomes (PROs) of participants using Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
Time frame: Up to 5 years
Management of AEs: Treatment of AEs
Time frame: Up to 5 years
Management of AEs: Date of occurrence of AE
Time frame: Up to 5 years
Management of AEs: Start of treatment
Time frame: Up to 5 years
Treatment Patterns: Previous therapies
Time frame: Up to 5 years
Treatment Patterns: Subsequent therapies
Time frame: Up to 5 years
Treatment patterns: Concomitant medication
Time frame: Up to 5 years
Treatment patterns : Management of treatment-related adverse events [AEs], previous and subsequent therapies
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 12 Dec 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
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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. This study is not recruiting at the moment.
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 Carcinoma, Non-Small-Cell Lung, 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 12 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 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?
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?
Overall survival (OS) (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 12 Dec 2024.