Non Small Cell Lung Cancer MetastaticNICReWoNCT07190677
First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial)
An observational study of Non Small Cell Lung Cancer Metastatic, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
NICReWo is an Italy-wide, multicenter, observational, ambispective study, designed to collect real-life data during the early post-market authorization approval period of the combination nivolumab plus ipilimumab plus chemotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non Small Cell Lung Cancer Metastatic
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jan 2025to 31 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with stage IV or recurrent NSCLC treated with nivolumab plus ipilimumab in combination with 2 cycles of platinum-based chemotherapy, according to local clinical practice.
Who may be able to join
- Diagnosis of stage IV or recurrent NSCLC (histologically or cytologically confirmed stage);
- Decision to initiate a first-line treatment with nivolumab plus ipilimumab in combination with 2 cycles of platinum-based chemotherapy for the treatment of NSCLC according to the Italian label, independently of the study, in patients whose tumors have no sensitising EGFR mutation or ALK translocation;
- Patient is at least 18 years of age at time of treatment decision;
- Patient provided written informed consent to participate in the study.
Who cannot join
- Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment;
- Previous treatment with nivolumab and/or ipilimumab;
- Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100
Francesco Augustoni, 0382501433, f.agustoni@smatteo.pv.it
About this study
Official title: First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic Non-small Cell Lung Cancer: an Ambispective, Observational, Italian, Multicenter, Real World Study (NICReWo Trial)
NICReWo is an Italy-wide, multicenter, observational, ambispective study, designed to collect real-life data during the early post-market authorization approval period of the combination nivolumab plus ipilimumab plus chemotherapy.
Data are retrospectively collected starting from January 2022 and will be prospectively collected until 31 December 2025, co-primary endpoints are to evaluate progression-free survival (PFS) and overall survival (OS) in a real world patient population. Secondary endpoints are overall response rate (ORR), duration of treatment and incidence of treatment-related adverse events (AEs). All data obtained for this study are recorded with an Electronic Data Capture (EDC) system using eCRFs (RedCap platform).
Read the detailed description
The major parameters collected are: patient characteristics (age, sex, ECOG, performance status, smoking status, comorbidities), disease characteristics (NSCLC histology, metastatic sites, molecular profile), treatment timeline (date of starting therapy, number of administered cycles, date and reason of end of therapy, best response, subsequent therapies after disease progression), survival outcomes [PFS (defined as the time from the starting therapy to disease progression or death from any cause) and OS (defined as the time from the starting therapy to death from any cause)]. Data about adverse drug reactions are collected according to the Common Terminology Criteria Adverse Events v5.0. Data collection includes patients treated starting from January 2022 until December, 31 2025, with a 2-years period of follow-up time.
- Conditions
- Non Small Cell Lung Cancer Metastatic
- Keywords
- Nivolumab, Ipilimumab, Real world
What is being measured
The primary outcome is the main question the study is designed to answer.
to estimate OS and PFS
to estimate the overall OS and the PFS after 24 months from start of therapy among patients with stage IV or recurrent NSCLC treated with nivolumab plus ipilimumab in combination with 2 cycles of platinum-based chemotherapy
Measured: January 2022 - December 2025
Secondary outcomes (4)
to estimate OS and PFS under real-life conditions in Italy considering subgroups
To estimate OS and PFS according to subgroups of interest: - ECOG Performance Status (PS): ECOG PS 0-1 and 2; - Presence of brain metastases; - Mediastinal lymph nodes staging: N0, N1, N2, N3; - Presence of extra-thoracic lymph node metastases; - Age >75 years; - Pre-existing autoimmune disorders; - Development of immune-related adverse events (AEs); - PD-L1 negative status; - Genetic mutations and co-mutations (KRAS, MET, BRAF or ROS1 genes or with resistance-conferring mutations in the STK11, KEAP1 and TP53 genes)
Measured: January 2022 - December 2025
to evaluate overall response rates by histology type, other subgroups of interest and treatment characteristics
To estimate the intermediate endpoints of response rates overall and according to histology types, other subgroups of interest and treatment characteristics with 24 months from start of therapy: - Overall response rate [ORR = Complete Response + Partial Response]; - Best overall response rate [BORR]
Measured: January 2022 - December 2025
to assess the overall duration of treatment and subdivide it according to histology types and other subgroups of interest
To estimate duration of treatment overall and according to histology types and other subgroups of interest
Measured: January 2022 - December 2025
to understand the safety of treatment by examining the frequency and severity of adverse events and identifying toxicity
To describe the frequency, severity, and management of following types of adverse events (AEs) to estimate toxicity up to 24 months from start of therapy:
- Selected immune-related AEs (immune-related pneumonitis, colitis, hepatitis, nephritis/renal dysfunction, endocrinopathies, and rash);
- Other immune-related AEs (severe infusion reactions, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, encephalitis, toxic epidermal necrolysis
Measured: January 2022 - December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start17 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
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 MetastaticStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Agustoni, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190677
- Sponsor's protocol ID
- NICReWo
- Acronym
- NICReWo
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic Non-small Cell Lung Cancer: an Ambispective, Observational, Italian, Multicenter, Real World Study (NICReWo Trial)
- ClinicalTrials.gov ID
- NCT07190677
- Acronym / sponsor ID
- NICReWo / NICReWo
- Conditions
- Non Small Cell Lung Cancer Metastatic
- Keywords
- Nivolumab, Ipilimumab, Real world
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Sep 2025 (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.
NICReWo is an Italy-wide, multicenter, observational, ambispective study, designed to collect real-life data during the early post-market authorization approval period of the combination nivolumab plus ipilimumab plus chemotherapy.
Data are retrospectively collected starting from January 2022 and will be prospectively collected until 31 December 2025, co-primary endpoints are to evaluate progression-free survival (PFS) and overall survival (OS) in a real world patient population. Secondary endpoints are overall response rate (ORR), duration of treatment and incidence of treatment-related adverse events (AEs). All data obtained for this study are recorded with an Electronic Data Capture (EDC) system using eCRFs (RedCap platform).
Detailed description
The major parameters collected are: patient characteristics (age, sex, ECOG, performance status, smoking status, comorbidities), disease characteristics (NSCLC histology, metastatic sites, molecular profile), treatment timeline (date of starting therapy, number of administered cycles, date and reason of end of therapy, best response, subsequent therapies after disease progression), survival outcomes [PFS (defined as the time from the starting therapy to disease progression or death from any cause) and OS (defined as the time from the starting therapy to death from any cause)]. Data about adverse drug reactions are collected according to the Common Terminology Criteria Adverse Events v5.0. Data collection includes patients treated starting from January 2022 until December, 31 2025, with a 2-years period of follow-up time.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with stage IV or recurrent NSCLC treated with nivolumab plus ipilimumab in combination with 2 cycles of platinum-based chemotherapy, according to local clinical practice.
Key inclusion criteria (4 listed)
- Diagnosis of stage IV or recurrent NSCLC (histologically or cytologically confirmed stage);
- Decision to initiate a first-line treatment with nivolumab plus ipilimumab in combination with 2 cycles of platinum-based chemotherapy for the treatment of NSCLC according to the Italian label, independently of the study, in patients whose tumors have no sensitising EGFR mutation or ALK translocation;
- Patient is at least 18 years of age at time of treatment decision;
- Patient provided written informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment;
- Previous treatment with nivolumab and/or ipilimumab;
- Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC.
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
to estimate OS and PFS
Time frame: January 2022 - December 2025
to estimate the overall OS and the PFS after 24 months from start of therapy among patients with stage IV or recurrent NSCLC treated with nivolumab plus ipilimumab in combination with 2 cycles of platinum-based chemotherapy
4 secondary outcomes
to estimate OS and PFS under real-life conditions in Italy considering subgroups
Time frame: January 2022 - December 2025
to evaluate overall response rates by histology type, other subgroups of interest and treatment characteristics
Time frame: January 2022 - December 2025
to assess the overall duration of treatment and subdivide it according to histology types and other subgroups of interest
Time frame: January 2022 - December 2025
to understand the safety of treatment by examining the frequency and severity of adverse events and identifying toxicity
Time frame: January 2022 - December 2025
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 24 Sep 2025.
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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.
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 Non Small Cell Lung Cancer Metastatic, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 24 Sep 2025. 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 Italy. 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 Francesco Agustoni, MD (0382501433, f.agustoni@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to estimate OS and PFS (time frame: January 2022 - December 2025). 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 24 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.