NCT07442890

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Lung Cancer

Interventions

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

Timeline

• Start date: 2026-04-30
• Primary completion: 2028-04-30
• Completion: 2028-06-30
• First posted: 2026-03-02
• Last updated: 2026-03-02