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NCT07442890Not yet recruiting

A Cohort Study on the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy for Lung Cancer Using Rolapitant and Palonosetron

A Cohort Study of the Combination Regimen Based on Rolapitant and Palonosetron for the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy in Lung Cancer Patients

Source: ClinicalTrials.gov · Last updated 2 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
238 (estimated)
First submitted
2 Feb 2026
Start date
30 Apr 2026
Primary completion date
30 Apr 2028
Lead sponsor
Henan Cancer Hospital
Diseases
Lung cancer
NCT number
NCT07442890

What you commit to

  • Study type: Interventional
  • Planned participants: 238
  • From 30 Apr 2026 to the primary completion date, 30 Apr 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.;
  • 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);

Other illness

  • Patients with a documented history of severe hypersensitivity to the active ingredient or excipients of the drug.
  • Presence of conditions affecting vomiting assessment, such as gastrointestinal obstruction, gastroparesis, or intestinal obstruction;
  • History of epilepsy or current use of antiepileptic drugs;
  • History of severe psychiatric disorders, substance abuse, alcoholism, or drug addiction;
  • 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;

Other

  • 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.
  • Pregnant or lactating women;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.