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

NCT07081256 | Completed Phase 3

• 1 other identifier: QLM2010-301
• Study Type: interventional
• Target: 665
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy-Induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Complete response during the overall phase after the start of the first cisplatin administration

  To compare the rate of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) after the start of the first cisplatin administration.

  [Time Frame: 0-120 hours after the start of the first cisplatin administration]

Study Arms (2)

Treatment group A

EXPERIMENTAL

QLM2010 + dexamethasone

Drug: QLM2010 for injection；dexamethasone

Treatment group B

ACTIVE COMPARATOR

fosaprepitant dimeglumine + palonosetron + dexamethasone

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

Interventions

QLM2010 for injection；dexamethasone DRUG

QLM2010 for injection；Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy

Treatment group A

fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone DRUG

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

Treatment group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhe jiangCancer Hospital

Hangzhou, China

Location

MeSH Terms

Conditions

Vomiting

Interventions

fosaprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: January 3, 2025
• Primary Completion: August 25, 2025
• Study Completion: October 15, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-07

Locations

CN (1)