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.
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;
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;
Parallel
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；
Dexamethasone
DrugDEX 12 mg, PO, QD; D2-D4: DEX 3.75 mg, PO, BID;
Olanzapine
DrugOlanzapine: 5 mg orally, QN, starting the night before the first chemotherapy session and continuing until 2 days after chemotherapy completion;
Complete Remission (CR) Rate
The proportion of patients who did not experience vomiting and did not require rescue therapy during concurrent chemoradiotherapy
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.
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.
Incidence of adverse events (AE)
Number of participants with adverse events (AE), drug-related adverse events, and serious adverse events (SAE)
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