H1-antihistaminE treatment in combiNation with immunotHerapy in pAtieNts with advanced non small cell lung canCEr: A single- center phase -ENHANCE

You may be able to join if

• • Capability of understanding the purpose of the study and have given written informed consent. • Histologically confirmed squamous or non-squamous NSCLC • Radiologically documented metastatic unresectable disease • Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) • No previous systemic therapy for metastatic disease • Patients who are planned to receive pembrolizumab monotherapy in routine indication and according to the marketing authorisation • Patient with a history of adequately treated, asymptomatic CNS metastases are eligible, provided they meet all of the following criteria: Only supratentorial metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord). No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed. • Age ≥ 18 years • ECOG-PS 0-2, KPS >70% • Adequate bone-marrow, liver and kidney function – except of a tumor-associated dysfunction due to metastatic NSCLC disease • No previous systemic therapy for metastatic disease. Patients who received prior radio- and/or chemotherapy in neoadjuvant or adjuvant indications before study inclusion are allowed in consideration of an adequate washout period before the enrolment. Adequate treatment washout period before enrolment, defined as: - Major Surgery: ≥4 weeks - Radiation therapy: ≥4 weeks - Chemotherapy: ≥2 weeks - Systemic steroid-treatment: ≥2 weeks • Patient must be able to tolerate therapy • Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days before first administration of IMP. Approved methods of birth control must be used in women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, from study start to the last dose of protocol therapy. Adequate contraception defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.