A Cohort Study on the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy for Lung Cancer Using Rolapitant and Palonosetron
Starting soon · Not applicable
Conditions studied: Lung Cancer
In brief
This study aims to evaluate the efficacy and safety of a combination regimen based on Rolapitant Palonosetron injection for preventing nausea and vomiting induced by concurrent chemoradiotherapy in lung cancer patients. It will also analyze the differences in preventive efficacy between two combination regimens, filling the gap in antiemetic data for radiotherapy combined with moderately to highly emetogenic chemotherapy. This research will provide evidence for optimizing antiemetic strategies in patients undergoing concurrent chemoradiotherapy.
Key facts
- Study ID
- NCT07442890
- Run by
- Henan Cancer Hospital
- People needed
- 238
- Starts
- 2026-04-30
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2026-03-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years, no gender restrictions;
- Histopathologically or cytologically confirmed lung cancer;
- Planned to receive concurrent chemoradiotherapy for at least 6 weeks, with radiotherapy administered in conventional fractions (2.0-2.2 Gy/fraction, 5 fractions/week, total dose 60-66 Gy); chemotherapy regimen includes highly emetogenic agents (e.g., cisplatin ≥60 mg/m²) ;
- ECOG Performance Status score: 0-1;
- Expected survival >12 weeks;
- Adequate organ and bone marrow function;
- Willingness to complete daily nausea/vomiting logs and scale assessments.
You may not qualify if…
- Patients with imaging-confirmed brain metastases accompanied by symptoms of increased intracranial pressure (e.g., headache, vomiting, papilledema) or objective evidence of elevated intracranial pressure.
- Patients with a documented history of severe hypersensitivity to the active ingredient or excipients of the drug.
- Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, dexamethasone, or olanzapine;
- Vomiting symptoms (≥1 episode/day) or VAS score ≥30 mm within 7 days prior to first administration;
- Use of medications with potential antiemetic effects within 2 days prior to first dose: first-generation 5-HT3 receptor antagonists (e.g., ondansetron), phenothiazines (e.g., prochlorperazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, secloperazine, etc.;
- Presence of conditions affecting vomiting assessment, such as gastrointestinal obstruction, gastroparesis, or intestinal obstruction;
- History of epilepsy or current use of antiepileptic drugs;
- Pregnant or lactating women;
- History of severe psychiatric disorders, substance abuse, alcoholism, or drug addiction;
- Currently participating in another interventional clinical trial, or having received treatment with another investigational drug or device within 4 weeks prior to the first dose (subjects who failed screening for another clinical trial may be included in this study);
- Presence of any other factors deemed by the investigator to increase study risk, compromise patient compliance with the protocol, or affect the patient's ability to complete the trial, such as physiological or psychological conditions;
Full record on ClinicalTrials.gov
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