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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Rolapitant Palonosetron; Drug: Dexamethasone; Drug: Olanzapine

Detailed Description

Rolapitant Palonosetron is a combination formulation containing 218 mg of foslora-palanitapentan and 0.25 mg of palo-nexon. It integrates an NK1 receptor antagonist (rolapitant) with a second-generation 5-HT3 receptor antagonist (palonosetron). This dual mechanism simultaneously blocks 5-HT3 and NK-1 pathways, inhibiting the vomiting reflex through dual pathways to provide long-lasting antiemetic efficacy.

The injectable formulation of Rolapitant Palonosetron exhibits an exceptionally long half-life of 188 hours. The PROFIT study demonstrated that a single injection per cycle provides coverage across the acute, delayed, and ultra-delayed phases of CINV, offering sustained protection for up to 8 days. It achieved a complete response (CR) rate exceeding 90% in both the acute and ultra-delayed phases across two consecutive chemotherapy cycles.

Existing studies predominantly focus on chemotherapy-only populations, with limited prospective data for concurrent chemoradiotherapy patients. The efficacy of currently used triple/quadruple antiemetic regimens in this setting requires further investigation, particularly the novel prophylactic strategy combining Rolapitant Palonosetron with dexamethasone ± olanzapine. Against this backdrop, 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.

• Study Type: Interventional
• Enrollment (Estimated): 238
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lijuan Chen, M.D.; Phone Number: 13837174273; Email: ljhappy8888@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rolapitant Palonosetron + DEX group; 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;	Drug: Rolapitant Palonosetron; • D1: 1 hour prior to chemotherapy administration: Rolapitant Palonosetron(Rolapitant 218mg and Palonosetron Medipentide 0.25mg), IV; 30 minutes prior to chemotherapy； Drug: Dexamethasone; DEX 12 mg, PO, QD; D2-D4: DEX 3.75 mg, PO, BID; Other Names: DEX
Experimental: Rolapitant Palonosetron + DEX + Olanzapine group; • 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;	Drug: Rolapitant Palonosetron; • D1: 1 hour prior to chemotherapy administration: Rolapitant Palonosetron(Rolapitant 218mg and Palonosetron Medipentide 0.25mg), IV; 30 minutes prior to chemotherapy； Drug: Dexamethasone; DEX 12 mg, PO, QD; D2-D4: DEX 3.75 mg, PO, BID; Other Names: DEX; Drug: Olanzapine; Olanzapine: 5 mg orally, QN, starting the night before the first chemotherapy session and continuing until 2 days after chemotherapy completion;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Remission (CR) Rate	The proportion of patients who did not experience vomiting and did not require rescue therapy during concurrent chemoradiotherapy	within 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Protection (CP) Rate	The proportion of patients who did not experience vomiting and did not require rescue therapy during concurrent chemoradiotherapy (within 6 weeks), and who did not experience significant nausea [Visual Analog Scale score < 25 mm];Nausea Visual Analog Scale (0-100 mm), with higher scores indicating more severe nausea.	within 6 weeks
Total Control (TC) Rate	The proportion of patients who did not experience vomiting and did not require rescue therapy during concurrent chemoradiotherapy (within 6 weeks), and did not experience nausea [Visual Analog Scale score < 5 mm];Nausea Visual Analog Scale (0-100 mm), with higher scores indicating more severe nausea.	within 6 weeks
Incidence of adverse events (AE)	Number of participants with adverse events (AE), drug-related adverse events, and serious adverse events (SAE)	within 6 weeks

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Investigators: Principal Investigator: Lijuan Chen, M.D., Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Benzazepines; Benzodiazepines; Olanzapine; Dexamethasone
• Other Study ID Numbers: HR20013-HN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No