Dexamethasone-sparing Approach Including NEPA Against Emesis Caused by Cisplatin

Inclusion Criteria:

* Patients ≥ 18 years old.
* Histologically or cytologically confirmed diagnosis of NSCLC
* Patients naїve to cisplatin-containing chemotherapy as well as any prior chemotherapy containing either highly or moderately emetogenic agents given for NSCLC or other malignancy.
* Patients scheduled to receive their first cycle of cisplatin-based chemotherapy at a dose ≥70 mg/m2 either alone or in combination with other agents of low or minimal potential of emetogenicity (i.e., pemetrexed, gemcitabine±bevacizumab, vinorelbine) as neo-adjuvant, adjuvant or palliative therapy. Patients with progressive disease on therapy with an EGFR-TKI (Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) and scheduled to receive cisplatin-based chemotherapy will be eligible for the study.
* ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-1.
* Body Mass Index ≥18.5.
* Written informed consent before study entry.
* If women of childbearing potential age: effective contraceptive measures must be used during all the planned course of chemotherapy and up to 30 days after last NEPA administration.
* Normal hepatic function (≤2 times the upper limit of normal for liver transaminases) and renal function (creatinine ≤ 1.5 times the upper limit of normal).
* Ability and willingness of the patient to complete the diary and study questionnaires.

Exclusion Criteria:

* Symptomatic brain metastases.
* Patients scheduled to receive radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5 following the first cycle of chemotherapy.
* Patients scheduled to receive concurrent chemo/radiotherapy for NSCLC.
* Treatment with investigational medications within 30 days before the study medication.
* Myocardial infarction within the last 6 months.
* Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK-1RA (Neurokinin-1 Receptor Antagonist) and excipients (see section 6.1 of Akynzeo SPC).
* Uncontrolled diabetes mellitus or active infection.
* Nausea and vomiting in the 24 hours before study treatment.
* Chronic use of systemic corticosteroids (except for topical and inhaled corticosteroids) or any other agent with anti-emetic potential. Patients receiving dexamethasone on the day before chemotherapy for prevention of the pemetrexed-induced skin rash will be eligible for the study.
* Patient's inability to take oral medication.
* Gastrointestinal obstruction or active peptic ulcer.
* Pregnancy or breast feeding.
* Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for at least 5 years (see also inclusion criteria if prior chemotherapy treatment).
* Psychiatric or CNS (Central Nervous System) disorders interfering with ability to comply with study protocol.