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

NCT07442890 | Not Yet Recruiting

• 1 other identifier: HR20013-HN-001
• Study Type: interventional
• Target: 238
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Complete Protection (CP) Rate

  within 6 weeks

• Total Control (TC) Rate

  within 6 weeks

• Incidence of adverse events (AE)

  within 6 weeks

Study Arms (2)

Rolapitant Palonosetron + DEX group

EXPERIMENTAL

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; Drug: Dexamethasone

Rolapitant Palonosetron + DEX + Olanzapine group

EXPERIMENTAL

• 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; Drug: Dexamethasone; Drug: Olanzapine

Interventions

Rolapitant Palonosetron DRUG

• D1: 1 hour prior to chemotherapy administration: Rolapitant Palonosetron(Rolapitant 218mg and Palonosetron Medipentide 0.25mg), IV; 30 minutes prior to chemotherapy；

Rolapitant Palonosetron + DEX + Olanzapine group; Rolapitant Palonosetron + DEX group

Dexamethasone DRUG

DEX 12 mg, PO, QD; D2-D4: DEX 3.75 mg, PO, BID;

Also known as: DEX

Rolapitant Palonosetron + DEX + Olanzapine group; Rolapitant Palonosetron + DEX group

Olanzapine DRUG

Olanzapine: 5 mg orally, QN, starting the night before the first chemotherapy session and continuing until 2 days after chemotherapy completion;

Rolapitant Palonosetron + DEX + Olanzapine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Dexamethasone; Olanzapine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lijuan Chen, M.D.

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lijuan Chen, M.D.

CONTACT

13837174273; ljhappy8888@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: March 2, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share