To Evaluate the Efficacy and Safety of QLM2010 for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy.

Qilu Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Chemotherapy-Induced Nausea and Vomiting

Treatments: Drug: QLM2010 for injection；dexamethasone; Drug: fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT07081256

QLM2010-301

Details and patient eligibility

About

Compared With Fosaprepitant dimeglumine for Injection and Palonosetron Hydrochloride Injection, to Evaluate the Efficacy and Safety of QLM2010 for Injection for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy.

Enrollment: 665 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able and willing to provide a written informed consent
• 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 poor blood pressure control after medication
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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665 participants in 2 patient groups

Treatment group A

Experimental group

Description:

QLM2010 + dexamethasone

Treatment:

Drug: QLM2010 for injection；dexamethasone

Treatment group B

Active Comparator group

Description:

fosaprepitant dimeglumine + palonosetron + dexamethasone

Treatment:

Drug: fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone