Clinical trial · Interventional
Study Assessing Fosaprepitant in Advanced NSCLC Patients Treated With Carboplatin Based Chemotherapy
Phase II, Double-blind, Placebo-controlled, Crossover Study Evaluating a 5HT3 Antagonist Plus Dexamethasone With or Without Fosaprepitant in Patients With Advanced NSCLC Receiving Carboplatin Based Chemotherapy
- 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)
This study evaluates the addition of fosaprepitant to currently available antiemtic treatments of carboplatin chemotherapy-induced nausea and vomiting in advanced non-small cell lung cancer patients. Half of the patients will receive fosaprepitant in their first chemotherapy cycle, and a placebo on their second chemotherapy cycle. The other half of the patients will begin their first chemotherapy cycle.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Emesis | — | UNRESOLVED | — |
| Nausea | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOSAPREPITANT (Emend) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fosparepitant administered in 1st cycle
- description
- Fosaprepitant (Emend) for Injection 150 mg is administered, one time, intravenously on day 1 only, as an infusion with a duration of 30 minutes. It will be initiated approximately 30 minutes prior to the subjects first chemotherapy cycle. An intravenous saline placebo will be administered on day 1 of the second chemotherapy cycle, in the same manor as EMEND for Injection.
- interventionNames
- Drug: FOSAPREPITANT (Emend)
- Drug: Placebo
- type
- SHAM_COMPARATOR
- label
- Fosaprepitant administered in 2nd cycle
- description
- Subject will receive a saline Placebo intravenously on day 1 of their first chemotherapy cycle. For the subject's second chemotherapy cycle, EMEND for Injection 150 mg is administered, one time, intravenously on day 1, as an infusion with a duration of 30 minutes. It will be initiated approximately 30 minutes prior to the subjects second chemotherapy cycle.
- interventionNames
- Drug: FOSAPREPITANT (Emend)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient age \> 18 years and able to sign informed consent. * ECOG PS 0-2 * Patients with stage IV or recurrent NSCLC being treated with carboplatin based regimen with palliative intent. * Acceptable chemotherapy regimens include: * Carboplatin (AUC of 5 OR 6) q 21 days with: * Paclitaxel Q 21 days OR * Docetaxel Q 21 days OR * Pemetrexed Q 21 days (non-squamous histology with Vitamin B12 and folate supplementation) OR * Gemcitabine administered days 1 and 8 Q 21 days OR * Vinorelbine administered days 1 and 8 Q 21 days * The addition of bevacizumab to chemotherapy is permitted where indicated and clinically appropriate. * Patients who have received prior adjuvant chemotherapy for lung cancer ( \> 1 year prior) and have recurred are eligible if it has been \> 1 year since completion of adjuvant chemotherapy. * Patients who have been treated for locally advanced lung cancer with concurrent chemoradiation but completed such therapy \> 1 year ago are eligible provided they meet all other inclusion criteria. * Patients who have received prior adjuvant chemotherapy for lung cancer ( \> 1 year prior) and have recurred are eligible if it has been \> 1 year since completion of adjuvant chemotherapy. * Patients who have been treated for locally advanced lung cancer with concurrent chemoradiation but completed such therapy \> 1 year ago are eligible provided they meet all other inclusion criteria. * Laboratory parameters: * Serum creatinine \< 2.0 and * AST, ALT \< 3 time the upper limit of normal * Platelet count ≥ 100,00/cumm * ANC ≥ 1500/ cumm on day of therapy (day # 1 of the cycle) * Hemoglobin \> 8.0 g/dl Exclusion Criteria: * History of allergic reaction to aprepitant or fosaprepitant * Use of other investigational agents concurrently with chemotherapy * Uncontrolled systemic hypertension with SBP \> 180 and/ or DBP\> 110 * Concurrent use of pimozide, terfenadine, astemizole, or cisapride (fosaprepitatnt is a dose-dependent inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4). If used concurrently with above agents, there can be elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions. Patients may be enrolled on the study if at least 7 days have elapsed since last dose of such a medication. * Women who are pregnant or lactating are not eligible. Women of childbearing age musthave a negative pregnancy test within 3 days of treatment and agree to use of contraception during the study period. * Use of any of the CYP450 inducers like phenytoin, carbamazepine, barbiturates, rifimapicin, rifabutin or St John's wort within 30 days.
References
Publications (4)
- BACKGROUNDFernandez-Ortega P, Caloto MT, Chirveches E, Marquilles R, Francisco JS, Quesada A, Suarez C, Zorrilla I, Gomez J, Zabaleta P, Nocea G, Llombart-Cussac A. Chemotherapy-induced nausea and vomiting in clinical practice: impact on patients' quality of life. Support Care Cancer. 2012 Dec;20(12):3141-8. doi: 10.1007/s00520-012-1448-1. Epub 2012 Mar 31. PMID 22460057
- BACKGROUNDWheatley-Price P, Le Maitre A, Ding K, Leighl N, Hirsh V, Seymour L, Bezjak A, Shepherd FA; NCIC Clinical Trials Group. The influence of sex on efficacy, adverse events, quality of life, and delivery of treatment in National Cancer Institute of Canada Clinical Trials Group non-small cell lung cancer chemotherapy trials. J Thorac Oncol. 2010 May;5(5):640-8. doi: 10.1097/JTO.0b013e3181d40a1b. PMID 20354457
- BACKGROUNDHesketh PJ, Kris MG, Grunberg SM, Beck T, Hainsworth JD, Harker G, Aapro MS, Gandara D, Lindley CM. Proposal for classifying the acute emetogenicity of cancer chemotherapy. J Clin Oncol. 1997 Jan;15(1):103-9. doi: 10.1200/JCO.1997.15.1.103. PMID 8996130
- BACKGROUNDGrunberg SM, Warr D, Gralla RJ, Rapoport BL, Hesketh PJ, Jordan K, Espersen BT. Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity--state of the art. Support Care Cancer. 2011 Mar;19 Suppl 1:S43-7. doi: 10.1007/s00520-010-1003-x. Epub 2010 Oct 24. PMID 20972805