Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT05418660
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05418660
Study Brief:
Protocol Section:
NCT05418660