Observational Retro-prospective Study on PD1/PDL1 Inhibitors Treatment Duration in Patients With NSCLC
I-STOP
1 other identifier
observational
300
1 country
10
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 19, 2022
CompletedFirst Submitted
Initial submission to the registry
May 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedSeptember 18, 2023
September 1, 2023
2.5 years
May 27, 2022
September 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Progression Free survival
Progression free survival (PFS) in the two cohorts; at least 24 months with Pembrolizumab, Nivolumab or Atezolizumab in any treatment line
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.
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
Through study completion, an average of 18 months
Study Arms (2)
Cohort 1
The cohort includes patients who discontinue the treatment at 24 months and continue the follow-up at least for 3 months
Cohort 2
The cohort includes patients who continue the treatment beyond 24 months until unacceptable toxicity or progression.
Interventions
At least 24 months with Pembrolizumab, Nivolumab or Atezolizumab in any treatment line
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
AOU Ospedali Riuniti
Ancona, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Ospedale Policlinico San Martino
Genova, Italy
Azienda Ospedaliero Universitaria
Modena, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900, Italy
Istituto Nazionale dei Tumori
Napoli, Italy
Azienda Ospedaliero Universitaria San Luigi
Orbassano, Italy
Azienda Ospedaliero Universitaria
Parma, Italy
Azienda Ospedaliera Marche Nord
Pesaro, Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diego Cortinovis, MD
Fondazione IRCCS San Gerardo dei Tintori, Monza
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2022
First Posted
June 14, 2022
Study Start
May 19, 2022
Primary Completion
November 30, 2024
Study Completion
November 30, 2024
Last Updated
September 18, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share
Data will be available upon request