Non-small Cell Lung CancerI-STOPNCT05418660
Observational Retro-prospective Study on PD1/PDL1 Inhibitors Treatment Duration in Patients With NSCLC
An observational study of Non-small Cell Lung Cancer, run by University of Milano Bicocca at 10 sites in Italy.
Trial summary
Retrospective/ prospective, multicentre, international observational study on long-responders with non-small cell lung carcinoma patients treated with anti Programmed cell Death 1/ Programmed cell Death Ligand 1 (anti-PD1/PD-L1) in any line of treatment for at least 24 months with response partial/complete response or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Immunotherapy
- How many people
- 300 participants
- Where
- 10 sitesItaly
- Study dates
- 19 May 2022to 30 Nov 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of NSCLC patients treated for at least 24 months with Pembrolizumab, Nivolumab or Atezolizumab in any treatment line. The patients should obtain and maintain a partial (RP) or complete response (RC) or stable disease (SD) at the end of the 24-month therapy.
Who may be able to join
- Age ≥ 18 years
- Histologically / cytologically confirmed diagnosis of NSCLC, with or without brain metastases
- Illness measurable according to Response Evaluation Criteria in Solid Tumours (iRECIST) criteria
- At least 24 months of treatment with Pembrolizumab, Nivolumab or Atezolizumab
- Complete response (CR)/ partial response (RP)/ stable disease at the end of 24-month treatment. The maintenance of the response may also have been obtained after loco-regional treatment, e.g. surgery or radiotherapy, in the case of oligoprogression for a maximum of 3 locoregional treatments (e.g. radiotherapy, surgery) throughout the period of treatment and suspension. Even progression at the brain level, treated with radiation therapy or surgery, can be considered, provided that it is followed by a disease control for at least 3 months.
- At least 3 months of follow-up or death within three months after stopping the 24-month treatment.
- Informed consent freely granted and acquired before the start of the study, for alive and contactable patients.
Who cannot join
- Initial chemo-immunotherapy treatment or association with other immunotherapy or other drugs in the context of clinical trials.
- Permanent discontinuation of treatment with anti PD-1 / PD-L1 for adverse events.
- More than 3 loco-regional treatments for maintaining the radiological response
- Suspension of immunotherapy for a period longer than 40 days during the 24-month treatment.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites, 10 recruiting
- Recruiting
AOU Ospedali Riuniti
Ancona
Rossana Berardi
- Recruiting
Azienda Ospedaliero Universitaria Careggi
Florence
Francesca Mazzone
- Recruiting
Ospedale Policlinico San Martino
Genova
Carlo Genova
- Recruiting
Azienda Ospedaliero Universitaria
Modena
Federica Bertolini
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900
Diego Cortinovis, MD, onco.noprofit@gmail.com
Elisa Sala, PhD, onco.noprofit@gmail.com
- Recruiting
Istituto Nazionale dei Tumori
Naples
Alessandro Morabito
- Recruiting
Azienda Ospedaliero Universitaria San Luigi
Orbassano
Simona Carnio
- Recruiting
Azienda Ospedaliero Universitaria
Parma
Alessandro Leonetti
- Recruiting
Azienda Ospedaliera Marche Nord
Pesaro
Rita Chiari
- Recruiting
Azienda Sanitaria Universitaria Friuli Centrale
Udine
Marianna Macerelli
About this study
Official title: Observational Retro-prospective Study on Programmed Cell Death 1/ Programmed Cell Death Ligand1 (PD1/PDL1) Inhibitors Treatment Duration in Patients With Non Small Cell Lung Carcinoma
Retrospective/ prospective, multicentre, international observational study on long-responders with non-small cell lung carcinoma patients treated with anti Programmed cell Death 1/ Programmed cell Death Ligand 1 (anti-PD1/PD-L1) in any line of treatment for at least 24 months with response partial/complete response or disease stability. Patients will be divided into two cohorts based on whether they stopped treatment at 24 months (not for toxicity) or continued by clinical choice and stratified according to treatment line and baseline PD-L1 expression.
Read the detailed description
Programmed cell Death protein / Ligand 1 (PD-1 / PD-L1) inhibitors Atezolizumab, Nivolumab and Pembrolizumab have demonstrated a great efficacy and a good safety profile in patients with Non-Small Cell Lung Cancer (NSCLC), both in first-line (PD-L1 expression > 50%) and in subsequent lines regardless of PD-L1 status. Recently, the combination of Pembrolizumab with platinum salts and pemetrexed has become the gold standard for the first-line treatment in patients with PD-L1 expression <50%. Data on the optimal duration of immunotherapy are scarce, especially considering that the onset of immune-related adverse events (irAE) has also been reported after several months of treatment and the long-term effects of the persistent immune system stimulation are unknown. Furthermore, predictive factors are not available to identify those patients who will respond to treatment and could benefit from a shorter duration of therapy -this information is pivotal to minimize the risk of side effects and improve the quality of life. Basal characteristics, such as PD-L1 expression, percentage of Cluster of Differentiation 8 (CD-8) + T-lymphocyte in tumor-infiltrating lymphocytes (TILs), mutational status, neutrophil to lymphocyte ratio (NLR), and platelets to lymphocytes ratio (PLR) have been reported as possible biomarkers, but further data are needed to confirm their predictive value. The purpose of the study is to identify the differences in terms of effectiveness and safety of immunotherapy in long-responder patients in the two cohorts. Secondary objectives are to evaluate the outcome after anti-PD1/PD-L1 rechallenge or other treatment for patients who progress after immunotherapy discontinuation and to identify baseline characteristics that may be predictive of response (molecular characteristics, biohumoral parameters, body mass index).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Immunotherapy
- Keywords
- NSCLC, Immunotherapy, nivolumab, atezolizumab, pembrolizumab
- 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.
ImmunotherapyDrug
Also called Nivolumab, Pembrolizumab, Atezolizumab
At least 24 months with Pembrolizumab, Nivolumab or Atezolizumab in any treatment line
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | The cohort includes patients who discontinue the treatment at 24 months and continue the follow-up at least for 3 months Receives: Drug: Immunotherapy | |
| Cohort 2 | The cohort includes patients who continue the treatment beyond 24 months until unacceptable toxicity or progression. Receives: Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free survival
Progression free survival (PFS) in the two cohorts; at least 24 months with Pembrolizumab, Nivolumab or Atezolizumab in any treatment line
Measured: Through study completion, an average of 18 months
Overall survival
Overall survival (OS) in the two cohorts; OS will be calculated from the first day of treatment until the date of death from any cause.
Measured: Through study completion, an average of 18 months
Percentage of patients with disease progression after 24 months of treatment
Proportion of patients who show disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start19 May 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (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 CancerStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera San Gerardo di Monza
- Responsible party
- Sponsor
- Investigators
- Diego Cortinovis, MD, Principal investigator, Fondazione IRCCS San Gerardo dei Tintori, Monza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418660
- Sponsor's protocol ID
- I-STOP
- Acronym
- I-STOP
- Status last verified
- Sep 2023
- First submitted
- 27 May 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retro-prospective Study on Programmed Cell Death 1/ Programmed Cell Death Ligand1 (PD1/PDL1) Inhibitors Treatment Duration in Patients With Non Small Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT05418660
- Acronym / sponsor ID
- I-STOP / I-STOP
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, Immunotherapy, nivolumab, atezolizumab, pembrolizumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera San Gerardo di Monza
- Study start
- 19 May 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 14 Jun 2022 (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.
Retrospective/ prospective, multicentre, international observational study on long-responders with non-small cell lung carcinoma patients treated with anti Programmed cell Death 1/ Programmed cell Death Ligand 1 (anti-PD1/PD-L1) in any line of treatment for at least 24 months with response partial/complete response or disease stability. Patients will be divided into two cohorts based on whether they stopped treatment at 24 months (not for toxicity) or continued by clinical choice and stratified according to treatment line and baseline PD-L1 expression.
Detailed description
Programmed cell Death protein / Ligand 1 (PD-1 / PD-L1) inhibitors Atezolizumab, Nivolumab and Pembrolizumab have demonstrated a great efficacy and a good safety profile in patients with Non-Small Cell Lung Cancer (NSCLC), both in first-line (PD-L1 expression > 50%) and in subsequent lines regardless of PD-L1 status. Recently, the combination of Pembrolizumab with platinum salts and pemetrexed has become the gold standard for the first-line treatment in patients with PD-L1 expression <50%. Data on the optimal duration of immunotherapy are scarce, especially considering that the onset of immune-related adverse events (irAE) has also been reported after several months of treatment and the long-term effects of the persistent immune system stimulation are unknown. Furthermore, predictive factors are not available to identify those patients who will respond to treatment and could benefit from a shorter duration of therapy -this information is pivotal to minimize the risk of side effects and improve the quality of life. Basal characteristics, such as PD-L1 expression, percentage of Cluster of Differentiation 8 (CD-8) + T-lymphocyte in tumor-infiltrating lymphocytes (TILs), mutational status, neutrophil to lymphocyte ratio (NLR), and platelets to lymphocytes ratio (PLR) have been reported as possible biomarkers, but further data are needed to confirm their predictive value. The purpose of the study is to identify the differences in terms of effectiveness and safety of immunotherapy in long-responder patients in the two cohorts. Secondary objectives are to evaluate the outcome after anti-PD1/PD-L1 rechallenge or other treatment for patients who progress after immunotherapy discontinuation and to identify baseline characteristics that may be predictive of response (molecular characteristics, biohumoral parameters, body mass index).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: ImmunotherapyThe cohort includes patients who discontinue the treatment at 24 months and continue the follow-up at least for 3 months |
| Cohort 2 | – | Drug: ImmunotherapyThe cohort includes patients who continue the treatment beyond 24 months until unacceptable toxicity or progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of NSCLC patients treated for at least 24 months with Pembrolizumab, Nivolumab or Atezolizumab in any treatment line. The patients should obtain and maintain a partial (RP) or complete response (RC) or stable disease (SD) at the end of the 24-month therapy.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Histologically / cytologically confirmed diagnosis of NSCLC, with or without brain metastases
- Illness measurable according to Response Evaluation Criteria in Solid Tumours (iRECIST) criteria
- At least 24 months of treatment with Pembrolizumab, Nivolumab or Atezolizumab
- Complete response (CR)/ partial response (RP)/ stable disease at the end of 24-month treatment. The maintenance of the response may also have been obtained after loco-regional treatment, e.g. surgery or radiotherapy, in the case of oligoprogression for a maximum of 3 locoregional treatments (e.g. radiotherapy, surgery) throughout the period of treatment and suspension. Even progression at the brain level, treated with radiation therapy or surgery, can be considered, provided that it is followed by a disease control for at least 3 months.
Key exclusion criteria (4 listed)
- Initial chemo-immunotherapy treatment or association with other immunotherapy or other drugs in the context of clinical trials.
- Permanent discontinuation of treatment with anti PD-1 / PD-L1 for adverse events.
- More than 3 loco-regional treatments for maintaining the radiological response
- Suspension of immunotherapy for a period longer than 40 days during the 24-month 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 |
|---|---|---|
| ImmunotherapyAlso: Nivolumab, Pembrolizumab, AtezolizumabAt least 24 months with Pembrolizumab, Nivolumab or Atezolizumab in any treatment line | Drug | Cohort 1, Cohort 2 |
Primary outcome
Progression Free survival
Time frame: Through study completion, an average of 18 months
Progression free survival (PFS) in the two cohorts; at least 24 months with Pembrolizumab, Nivolumab or Atezolizumab in any treatment line
Overall survival
Time frame: Through study completion, an average of 18 months
Overall survival (OS) in the two cohorts; OS will be calculated from the first day of treatment until the date of death from any cause.
Percentage of patients with disease progression after 24 months of treatment
Time frame: Through study completion, an average of 18 months
Proportion of patients who show disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No. Data will be available upon request
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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.
Diego Cortinovis, MD principal investigator
Fondazione IRCCS San Gerardo dei Tintori, Monza
10 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, run by University of Milano Bicocca at 10 sites 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego Cortinovis, MD (0392336040, diegoluigi.cortinovis@irccs-sangerardo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free survival (time frame: Through study completion, an average of 18 months). The study lists 3 primary outcomes in all. 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 Sep 2023.