Clinical trial · Interventional
Safety and Efficacy of Aprepitant for CINV in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy
Safety and Efficacy of Aprepitant for Chemotherapy-Induced Nausea and Vomiting in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy
NCT02445872CI-TRIAL-00020123unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Aprepitant is an oral neurokinin-1(NK-1) antagonist which is used for the prevention of chemotherapy-induced nausea and vomiting (CINV). This phase II clinical trial was designed to evaluate the efficacy of aprepitant in the prevention of CINV with lung cancer patients receiving 3-day cisplatin-based chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-Induced Nausea and Vomiting | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aprepitant | Drug | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Palonosetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Aprepitant: 125mg PO on day1, 80mg PO on day2 and day3. Palonosetron (a 5-HT3 receptor antagonist): 0.25 mg IV push on day 1 only. Dexamethasone: 5mg IV push once daily from day 1 to day 3,and 3.75mg PO on days 4-5.
- interventionNames
- Drug: Aprepitant
- Drug: Palonosetron
- Drug: Dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Palonosetron: 0.25 mg IV push on day 1 only. Dexamethasone: 5mg IV push once daily from day 1 to day 3,and 7.5mg PO on days 4-5.
- interventionNames
- Drug: Palonosetron
- Drug: Dexamethasone
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient who was confirmed lung cancer by pathologic histology or cytology. 2. Males or females aged ≥18 years, \<80 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks. 4. Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug. 5. Patients with asymptomatic, treated brain metastases are eligible for trial participation. 6. Adequate bone marrow, renal, and liver function are required. 7. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications. 8. Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment. Exclusion Criteria: 1. History of sensitivity/idiosyncrasy to aprepitant or excipients 2. Condition that might interfere with drug absorption, distribution metabolism or excretion. 3. Concomitant use of agents that are known to interfere with aprepitant pharmacokinetics 4. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). 5. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease. 6. Female subjects should not be pregnant or breast-feeding. 7. Inadequate hematological function. 8. Abnormal liver and renal function. 9. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
References
Publications (1)
- RESULTGao HF, Liang Y, Zhou NN, Zhang DS, Wu HY. Aprepitant plus palonosetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy. Intern Med J. 2013 Jan;43(1):73-6. doi: 10.1111/j.1445-5994.2011.02637.x. PMID 22141732