To Evaluate the Efficacy and Safety of QLM2010 for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy.
NCT ID: NCT07081256
Last Updated: 2025-11-18
Study Results
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Basic Information
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COMPLETED
PHASE3
665 participants
INTERVENTIONAL
2025-01-03
2025-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Treatment group A
QLM2010 + dexamethasone
QLM2010 for injection；dexamethasone
QLM2010 for injection；Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy
Treatment group B
fosaprepitant dimeglumine + palonosetron + dexamethasone
fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone
fosaprepitant dimeglumine for injection: Drug for preventing nausea and vomiting caused by chemotherapy palonosetron hydrochloride injection: Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy
Interventions
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QLM2010 for injection；dexamethasone
QLM2010 for injection；Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy
fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone
fosaprepitant dimeglumine for injection: Drug for preventing nausea and vomiting caused by chemotherapy palonosetron hydrochloride injection: Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older, of either gender
* Has a diagnosed malignant solid tumor through histological or cytological examination
* Has never been treated with chemotherapy (Antitumor drugs are not used for cancer treatment, or intravesical instillation therapy for bladder cancer is not regarded as chemotherapy)
* Receive the first course of cisplatin-based chemotherapy
* Has a performance status (ECOG scale) of 0 to 2
* Predicted life expectancy of ≥ 3 months
Exclusion Criteria
* Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastasis or intracranial hypertension
* Subjects with a history of severe cardiovascular diseases within 3 months prior to the administration of cisplatin, such as acute myocardial infarction, NYHA class II-IV heart failure, etc.
* Subjects with a history of severe torsional ventricular tachycardia, QTcF\>480 ms
* Subjects with mental disabilities or severe emotional or mental disorders, The investigators determined that inappropriate for participation in this clinical trial
* Inadequate bone marrow, kidney, and liver function 10. Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -7 through Day 6
* Scheduled to receive moderately or highly emetogenic chemotherapy from Day 2 through Day 6
* Subjects who have experienced emetic events (vomiting or dry vomiting) or nausea within 24 hours before cisplatin-based chemotherapy
* Participated in clinical trials of other drugs within 30 days prior to the administration of cisplatin (received experimental drugs)
* Subjects receiving palonosetron hydrochloride within 21 days before cisplatin-based chemotherapy. Subjects who previously received NK-1 receptor antagonists within 28 days prior to cisplatin-based chemotherapy. Subjects receiving glucocorticoid within 7 days before cisplatin-based chemotherapy.
* Has taken the following agents within the last 48 hours 5-HT3 antagonists, Phenothiazines, Benzamides, Domperidone, Cannabinoids, Benzodiazepines, etc.
* The investigators determined that other conditions were inappropriate for participation in this clinical trial
18 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Zhe jiangCancer Hospital
Hangzhou, , China
Countries
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Other Identifiers
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QLM2010-301
Identifier Type: -
Identifier Source: org_study_id
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