PEMBROLIZUMAB for Advanced non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Participants must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care.\n- Participants must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.\n- Subjects with cytologically or histologically confirmed advanced stage or recurrent NSCLC (per the 8th International Association for the Study of Lung Cancer classification), eligible for treatment with pembrolizumab in line with ESMO guidelines.\n- Known PD-L1 status (performed on cytology or histology).\n- Subjects are aged ≥ 18 years.\n- Women must not be breastfeeding.\n- Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of 5 months (30 days of ovulatory cycle plus the time required for the investigational drug to undergo five half-lives) after end of pembrolizumab treatment.\n- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of 7 months (90 days plus the time required for pembrolizumab to undergo five half-lives) after the last dose of investigational drug. In addition, male participants must be willing to refrain from sperm donation during this time."}

Exclusion criteria

• {"criterion_text":"- Subjects with symptomatic untreated CNS metastases are excluded. i) Subjects are eligible if CNS metastases are asymptomatic or adequately treated and neurological symptoms have returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrolment. ii) In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment assignment.\n- Total body weight <40 or >140 kg.\n- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrolment. Inhaled or topical steroids, and steroids for adrenal replacement therapy are permitted.\n- A known CD4+ T-cell count of less than 100 cells/μL (CD4+ T cell count measurement is not required for patients without a history of low CD4+ T cell counts or HIV).\n- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n- Treatment with adjuvant or neoadjuvant chemotherapy 3 months prior to enrolment.\n- Non-palliative treatment with chemoradiation for locally advanced disease 3 months prior to enrolment. Palliative radiotherapy is allowed any time.\n- Women of childbearing potential (WOCBP) with a known pregnancy or a positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) prior to the start of study treatment.\n- History of allergy or hypersensitivity to study drug components.\n- Subjects may not have previously received a solid organ transplantation."}

Primary endpoints

• {"endpoint_text":"- The primary study parameter is the overall survival rate at one year.","definition_or_measurement_approach":"Not specified in the provided record."}

Netherlands

Earliest CTIS Part Ii Submission Date

29-08-2024

Latest Decision Or Authorization Date

29-10-2025

Processing Time Days

426

Number Of Sites

30

Number Of Participants

750

Primary sponsor

Full Name

Stichting Radboud universitair medisch centrum

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands