Chemotherapy-Induced Nausea and Vomiting
Conditions
Interventions
Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone:Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone
Fosrolapitant and Palonosetron Hydrochloride for Injection:Fosrolapitant and Palonosetron Hydrochloride for Injection
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent form and voluntary participation in this study; 2. Age 18–75 years at enrollment, regardless of gender; 3. Patients with histopathologically confirmed advanced non-small cell lung cancer; 4. Scheduled to receive ICI (PD-1/PD-L1 inhibitor) combined with a moderately/highly emetogenic platinum-based chemotherapy regimen for the first time, and the chemotherapy regimen does not contain drugs requiring therapeutic-dose corticosteroid premedication; 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0–1; 6. Expected survival duration >= 3 months; 7. Adequate organ function as defined below: a) Hematological function: Absolute neutrophil count >= 1.5×10?/L, hemoglobin >= 90 g/dL, platelets >= 100×10?/L; b) Hepatic function: Total bilirubin = 30 g/dL; c) Renal function: Serum creatinine = 60 mL/min; d) Coagulation function: International normalized ratio (INR) = 50%; 8. Female subjects of childbearing potential, and male subjects whose partners are female of childbearing potential, must use effective contraceptive measures (e.g., intrauterine device, contraceptive pills, or condoms with an annual failure rate of less than 1%) from the time of signing the informed consent form until 6 months after the last dose of study drug. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to enrollment and must not be breastfeeding; 9. Subjects must have good adherence and be willing to comply with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Presence of nausea, vomiting, or retching within 24 hours before chemotherapy; 2. Received antiemetic therapy within 48 hours before chemotherapy (including NK-1 receptor antagonists, 5-HT3 receptor antagonists, corticosteroids, benzodiazepines, opioids, etc.); 3. Received abdominal or pelvic radiotherapy within 7 days before enrollment, or other antitumor therapy (such as chemotherapy, targeted therapy, immunotherapy, radiotherapy, etc.) within 28 days before enrollment; 4. Received NK-1 receptor antagonist therapy within 28 days before enrollment, or 5-HT3 receptor antagonist therapy within 14 days before enrollment; 5. Planned to use chemotherapy drugs requiring premedication with therapeutic-dose corticosteroids (e.g., paclitaxel); 6. Requiring systemic corticosteroids for therapeutic purposes at baseline (>10 mg/day prednisone equivalent), or expected to require long-term use of such doses during the study; 7. Known hypersensitivity to any component of the study drug; 8. Pregnant or breastfeeding women (female subjects must have a negative pregnancy test before enrollment, and effective contraception must be used during the study and for 6 months after the last treatment); 9. Presence of uncontrolled severe organic diseases, including: severe heart disease (e.g., NYHA class III-IV heart failure, uncontrolled arrhythmia, acute myocardial infarction within the past 6 months, or severe coronary artery disease), severe hepatic or renal insufficiency (Child-Pugh class B or higher liver function, creatinine clearance = 200 IU/mL or 1000 copies/mL or >= upper limit of normal) or hepatitis C (positive anti-HCV antibody with HCV RNA above the lower limit of detection of the assay); 16. Participation in other clinical trials within 30 days before enrollment (defined as having received the investigational product); 17. Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in this study (e.g., poor adherence, inability to complete diary records, comorbidities affecting study assessments, etc.);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate during the overall period of the first chemotherapy cycle; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate and proportion of patients without rescue medication in the acute phase, delayed phase, and overall phase of the first and second chemotherapy cycles; | — |
Countries
China
Contacts
Public ContactXiaoxia Chen
Shanghai Pulmonary Hospital
Outcome results
None listed