ChiCTR1900025227.

Study name	A randomized, open, parallel controlled phase II clinical study comparing the efficacy and safety of dexamethasone, palonosetron, or aprepitant in the control of acute and delayed vomiting in non‐small cell lung cancer patients receiving multiple moderately emetogenic chemotherapy regimens
Methods	Randomised, interventional, active‐controlled study with 2 arms comparison of aprepitant + palonosetron + dexamethasone vs palonosetron + dexamethasone Target sample size: 100 Masking: open‐label Baseline patient characteristics: not available
Participants	Inclusion criteria treatment‐naïve non‐small cell lung cancer patients who can complete 4 to 6 cycles of moderate emetic regimen chemotherapy aged > 18 years delayed vomiting after chemotherapy and subsequent chemotherapy Karnofsky score > 60 life expectancy > 3 months main organ functions normal, that is to say, the following criteria should be met: blood routine examination criteria: HB > 90 g/L (no blood transfusion within 14 days) ANC > 1.5 × 10⁹/L PLT > 75 × 10⁹/L biochemical examination criteria: TBIL < 1.5 ULN (upper limit of normal value) ALT and AST < 3.0 ULN if liver metastasis, ALT and AST < 3.0 ULN AST < 5 ULN, serum Cr < 1 ULN, endogenous creatinine clearance rate > 60 mL/min (Cockcroft‐Gault formula) can read, understand, and complete research questionnaires and logs, including the Nausea and Vomiting Questionnaire (FLIE) and dietary diary questions  Exclusion criteria received research drugs outside the scope of the study in the past 4 weeks or during the study period, and toxicity of recent treatment has not been eliminated pregnant women, breast‐feeding women, women of child‐bearing age who want to be pregnant or who use only oral contraceptives important organ disorder or disease, such as history of myocardial infarction, severe epilepsy requiring medication, etc. mental disability or severe emotional or mental disorder history of other malignant tumour within 5 years (excluding cured cervical or skin basal cell carcinoma) uncontrolled diseases, such as active infection (such as pneumonia) or diabetic ketoacidosis or gastrointestinal obstruction may be biased by results of the study or exposed to unnecessary risk in patients receiving the drug receiving any dose of systemic glucocorticoid therapy; however, local and inhaled glucocorticoids are allowed  Mean/median age, years: not available Gender: both Tumour/cancer type: non‐small cell lung cancer Chemotherapy regimen: not reported, moderately emetogenic chemotherapy Country: China
Interventions	Experimental: arm A: aprepitant/palonosetron/dexamethasone Intervention details not reported Experimental: arm B: palonosetron/dexamethasone Intervention details not reported
Outcomes	Primary outcomes complete response rate of acute CINV complete response rate of delayed CINV Secondary outcomes none reported
Starting date	15 August 2019
Contact information	Research and public contact: Zhang Lemeng (Hunan Cancer Hospital, 283 Tongzipo Road, Yuelu District, Changsha, Hu'nan, China, email: zhanglemeng@hnca.org.cn)
Notes	funding: Hunan Cancer Hospital  unique ID issued by ChiCTR: ChiCTR1900025227