Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Olanzapine | Drug | — | UNRESOLVED |
| Rolapitant Palonosetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rolapitant Palonosetron + DEX group
- description
- D1: 1 hour prior to chemotherapy administration: Rolapitant Palonosetron (Rolapitant 218 mg and Palonosetron Hydrochloride 0.25 mg), IV; 30 minutes prior to chemotherapy: DEX 12 mg, PO, QD;D2-D4: DEX 3.75 mg, PO, BID;
- interventionNames
- Drug: Rolapitant Palonosetron
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- Rolapitant Palonosetron + DEX + Olanzapine group
- description
- • D1: 1 hour prior to chemotherapy administration: Rolapitant Palonosetron (Rolapitant 218 mg and Palonosetron Hydrochloride 0.25 mg), IV; 30 minutes prior to chemotherapy: DEX 12 mg, PO, QD; * D2-D4: DEX 3.75 mg, PO, BID; * Olanzapine: 5 mg orally, QN, starting the night before the first chemotherapy session and continuing until 2 days after chemotherapy completion;
- interventionNames
- Drug: Rolapitant Palonosetron
- Drug: Dexamethasone
- Drug: Olanzapine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years, no gender restrictions; 2. Histopathologically or cytologically confirmed lung cancer; 3. 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) ; 4. ECOG Performance Status score: 0-1; 5. Expected survival \>12 weeks; 6. Adequate organ and bone marrow function; 7. Willingness to complete daily nausea/vomiting logs and scale assessments. Exclusion Criteria: 1. 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. 2. Patients with a documented history of severe hypersensitivity to the active ingredient or excipients of the drug. 3. Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, dexamethasone, or olanzapine; 4. Vomiting symptoms (≥1 episode/day) or VAS score ≥30 mm within 7 days prior to first administration; 5. 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.; 6. Presence of conditions affecting vomiting assessment, such as gastrointestinal obstruction, gastroparesis, or intestinal obstruction; 7. History of epilepsy or current use of antiepileptic drugs; 8. Pregnant or lactating women; 9. History of severe psychiatric disorders, substance abuse, alcoholism, or drug addiction; 10. 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); 11. 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;
References
Publications (0)
Data not yet available