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

Sponsor
Henan Cancer Hospital
Study ID
NCT07442890
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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；
  • Dexamethasone — DRUG
    DEX 12 mg, PO, QD; D2-D4: DEX 3.75 mg, PO, BID;
  • Olanzapine — DRUG
    Olanzapine: 5 mg orally, QN, starting the night before the first chemotherapy session and continuing until 2 days after chemotherapy completion;

Study Details

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.

Key Dates

First listed
Mar 2, 2026
Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Apr 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
238 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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;
  • 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;

Primary Outcome Measure

Complete Remission (CR) Rate [ Time Frame: within 6 weeks ]

Central Contacts

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