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. Author manuscript; available in PMC: 2023 May 30.
Published in final edited form as: Contemp Clin Trials. 2022 Nov 26;124:107030. doi: 10.1016/j.cct.2022.107030

Table 2. Summary of exclusion criteria for REFINE (full list available on REFINE website [27]).

Exclusion criteria
• Patients who have received ICI in a prior line of treatment
• Patients who have undergone any prior systemic anti-cancer treatment
• Patients where treatment is the combination of anti-PD-1 and tyrosine kinase inhibitor or the combination of cytotoxic chemotherapy and anti-PD-1
• History of another previous malignancy (some exceptions apply)
• Concurrent enrolment in another interventional clinical study, unless in the follow-up period, except where approved by the CTU
• Current or prior use of immunosuppressive medication within 14 days of starting trial treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
• Active infection including Tuberculosis, Hepatitis B, Hepatitis C and HIV
• Patients who have received a live attenuated vaccine within 30 days prior to the start of treatment
• Known allergy or hypersensitivity to immune checkpoint inhibitor
• Pregnant or breastfeeding patients
• Uncontrolled adrenal insufficiency
• Any serious or uncontrolled medical or psychiatric disorder that, in the opinion of the investigator, may increase the risk associated with study participation
• Untreated brain metastases or brain metastases treated only with whole brain radiotherapy