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:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT04007068
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years;
* Cytologically or histologically confirmed NSCLC with PD-L1 TPS ≥1% (confirmed by a validated test);
* Stage IVa, IVb or recurrent NSCLC (classification IASLC, 7th edition, 2009);
* Up to 10 metastases in multiple organ systems, or more than 10 metastases in more than two organ systems;
* No signs of active and/or untreated brain metastases;
* At least three measurable lesions;
* Progression after the first or second-line systemic therapy;
* WHO performance status 0-2 (ECOG criteria);
* Following the decision of multidisciplinary board that the patient is a candidate for treatment with pembrolizumab;
* FDG PET/CT performed up to 4 weeks prior to treatment;
* Performed diagnostic CT scans (thorax and abdomen) up to 4 weeks prior to treatment;
* Signed and dated written informed consent.
Exclusion Criteria:
Symptomatic and/or untreated brain metastases;
* History of other malignancies, except for the following: adequately treated basal or squamous cell carcinoma of the skin, curatively treated in situ carcinoma of the uterine cervix, other curatively treated solid tumour with no evidence of disease for ≥ 3 years;
* All contraindications for treatment with pembrolizumab.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04007068
Study Brief:
Protocol Section:
NCT04007068