An interventional study of Rolapitant Palonosetron and Dexamethasone in Lung Cancer, sponsored by Henan Cancer Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Henan Cancer Hospital · Not applicable, Interventional, and Prevention
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 238 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.
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Exclusion Criteria:
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
• 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
• D1: 1 hour prior to chemotherapy administration: Rolapitant Palonosetron(Rolapitant 218mg and Palonosetron Medipentide 0.25mg), IV; 30 minutes prior to chemotherapy；
DEX 12 mg, PO, QD; D2-D4: DEX 3.75 mg, PO, BID;
Also known as: DEX
Olanzapine: 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
Time frame: within 6 weeks
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.
Time frame: 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.
Time frame: within 6 weeks
Incidence of adverse events (AE)
Number of participants with adverse events (AE), drug-related adverse events, and serious adverse events (SAE)
Time frame: within 6 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Henan Cancer Hospital