Status:
UNKNOWN
Observational Retro-prospective Study on PD1/PDL1 Inhibitors Treatment Duration in Patients With NSCLC
Lead Sponsor:
University of Milano Bicocca
Collaborating Sponsors:
Azienda Ospedaliera San Gerardo di Monza
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
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 Dea...
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 Cel...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05418660
Start Date
May 19 2022
End Date
November 30 2024
Last Update
September 18 2023
Active Locations (10)
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1
AOU Ospedali Riuniti
Ancona, Italy
2
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
3
Ospedale Policlinico San Martino
Genova, Italy
4
Azienda Ospedaliero Universitaria
Modena, Italy