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

I-STOP

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.

2022-05-19

2024-11-30

2024-11-30

Recruiting

300

Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically / cytologically confirmed diagnosis of NSCLC, with or without brain metastases 3. Illness measurable according to Response Evaluation Criteria in Solid Tumours (iRECIST) criteria 4. At least 24 months of treatment with Pembrolizumab, Nivolumab or Atezolizumab 5. 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. 6. At least 3 months of follow-up or death within three months after stopping the 24-month treatment. 7. Informed consent freely granted and acquired before the start of the study, for alive and contactable patients. Exclusion Criteria: 1. Initial chemo-immunotherapy treatment or association with other immunotherapy or other drugs in the context of clinical trials. 2. Permanent discontinuation of treatment with anti PD-1 / PD-L1 for adverse events. 3. More than 3 loco-regional treatments for maintaining the radiological response 4. Suspension of immunotherapy for a period longer than 40 days during the 24-month treatment.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

2023-09-18