The Efficacy and Safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in Preventing Nausea and Vomiting Caused by Multi-cycle Immunotherapy and Chemotherapy in Patients With Esophageal Cancer and Lung Cancer

NCT07617246 | Recruiting Phase 2 DMC

• 1 other identifier: FEAL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a randomized, parallel, cohort study to evaluate the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in preventing nausea and vomiting caused by multi-cycle immunotherapy and chemotherapy in patients with esophageal cancer and lung cancer. A total of 120 subjects are planned to be enrolled, with 60 in each cohort. 40% of the subjects will undergo an interim analysis upon completion of the study. The trial consists of a screening period, a treatment period and a safety follow-up period. Drug treatment was administered in accordance with the trial protocol, and then the corresponding follow-up and examination were completed in accordance with the trial process table. During the research period, if the researcher assesses that the subjects indeed need to use remedial antiemetic drugs, remedial treatment can be carried out based on clinical practice. The specific types, usage, dosage and frequency of the drugs are determined by the researcher.

Conditions

Esophagus Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects who achieved complete remission (CR: no vomiting and remedial treatment) in the super-delayed period (120 hour-168 hour) after the start of each immunotherapy combined with chemotherapy cycle;

  The super-delayed period (120 hour-168 hour) after the start of each immunotherapy combined with chemotherapy cycle，each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.

Secondary Outcomes (3)

• The CR rate in the acute phase (0 hour-24 hour), delayed phase (24 hour-120 hour), overall phase (0 hour-120 hour), and 0 hour-168 hour of each immunotherapy combined with chemotherapy cycle;

  Each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.

• The time of the first vomiting

  Each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.

• The impact of chemotherapy-induced nausea and vomiting (CINV) on quality of life

  Each cycle is 21 days. Total of 4 treatment cycles of immunotherapy combined with chemotherapy were observed.

Study Arms (2)

1

EXPERIMENTAL

Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetate

Drug: Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetate

2

PLACEBO COMPARATOR

For injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetate

Drug: For injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetate

Interventions

Fosrolapitant and Palonosetron Hydrochloride for Injection combined with dexamethasone acetate DRUG

Fosrolapitant and Palonosetron Hydrochloride for Injection: Intravenous drip for 1 hour (+10 minutes), once before each cycle of chemotherapy. Dexamethasone acetate: Take 12mg orally on the first day of each chemotherapy cycle before chemotherapy, and 3.75mg orally on the second to fourth days twice a day.

1

For injection, fosapirtan dimeglumine combined with palonosetron hydrochloride and dexamethasone acetate DRUG

Fosapirtan dimeglumine for injection: 150mg, intravenous drip for 20-30 minutes, administered once before each cycle of chemotherapy. Palonosetron hydrochloride: 0.25mg, intravenous injection for at least 30 seconds, administered once before each cycle of chemotherapy. Dexamethasone acetate: Take 6mg orally on the first day of each chemotherapy cycle before chemotherapy, 3.75mg orally once on the second day, and 3.75mg orally every day from the third to the fourth day.

2

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old, gender not limited;
• Histologically or cytologically confirmed untreated locally advanced/metastatic esophageal cancer and lung cancer;
• Has not received any chemotherapy drugs in the past (anti-tumor drugs are not used for cancer treatment);
• Plan to receive at least 4 cycles of chemotherapy combined with immunotherapy based on cisplatin and carboplatin;
• Expected survival period ≥3 months;
• Eastern Cooperative Oncology Group (ECOG) Physical Condition score: 0 or 1 point;
• Good organ function, meeting the following criteria:
• Neutrophil count ≥1.5×109/L;
• Hemoglobin ≥ 90g/L;
• Platelet count ≥ 100×109/L;
• Total bilirubin ≤1.5×ULN In patients without known liver metastases, aspartate aminotransferase ≤2.5×ULN and/or alanine aminotransferase ≤2.5×ULN (for patients with liver metastases, it can be relaxed to ≤5×ULN);
• f: Serum creatinine ≤1.5×ULN or creatinine clearance rate ≥ 50ml/min; g: Electrocardiogram: QTc≤450ms (for males), QTc≤470ms (for females); h: Cardiac color Doppler ultrasound: LVEF (left ventricular ejection fraction) ≥50%;
• Fertile female subjects and male subjects whose partners are fertile women need to adopt an effective contraceptive measure from the time of signing the informed consent form until 6 months after the last administration. Female subjects with fertility must have a negative blood pregnancy test within 72 hours before randomization. And it must be non-lactation period;
• Clearly understand and voluntarily participate in this research, and sign the informed consent form by oneself.

You may not qualify if:

• Abdominal (including the diaphragmatic plane and below) or pelvic radiotherapy was received within 7 days prior to randomization, or is planned to be received within 1 to 8 days of treatment;
• It is planned to administer chemotherapy drugs with a high risk of vomiting within 2 to 8 days after platinum infusion.
• Plan to receive chemotherapy regimens including common paclitaxel (using castor oil as the solvent);
• Take drugs with potential antiemetic effects within 2 days before randomization: The first-generation 5-HT3 receptor antagonists (such as ondansetron), phenthiazide drugs (such as prochlorazine), butanylbenzene drugs (such as haloperidol), benzamides (such as metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, cyclezine, etc.
• Start treatment with benzodiazepines or opioid preparations within 2 days before randomization (except for triazolam, temazepam or midazolam taken alone daily);
• Subjects who began using morphine within 7 days before randomization (except those taking a stable dose);
• Within 7 days before randomization, systemic corticosteroid therapy (including but not limited to dexamethasone, hydrocortisone, methylprednisolone or prednisolone) or sedative antihistamines (such as diphenhydramine) were received (Note: Single use of steroids is allowed to prevent contrast agent allergy and local administration or inhalation), except for those who need hormone pretreatment one day before chemotherapy.
• Palonosetron was used within 14 days prior to randomization;
• Use NK-1 receptor antagonists within 28 days before randomization;
• Specific CYP3A4 substrates (terfenadine, cisapride, asemidazole) or CYP3A4 inhibitors (such as ritonavir, clarithromycin, ketoconazole or itraconazole, diltiazem, etc.) were used within 7 days before randomization. Strong CYP3A4 inducers (such as phenobarbital, rifampicin, phenytoin and carbamazepine) or specific CYP2D6 substrates (thiolidazine, pimozide) were used within 28 days before randomization;
• Vomiting and/or retching and nausea occurred within 24 hours before randomization; Subjects with symptomatic brain metastases;
• Accompanied by poorly controlled serous cavity effusion, including pleural effusion, ascites, and pericardial effusion (those that have been controlled after treatment and remained stable for ≥2 weeks can be included);
• Having severe cardiovascular diseases within 3 months prior to randomization, including but not limited to acute myocardial infarction, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic chronic heart failure (New York Heart Association \[NYHA\] grades II to IV), and history of severe cardiac conduction abnormalities (such as torus cuspidata ventricular tachycardia);
• Poorly controlled hypertension (two consecutive resting systolic blood pressures ≥160mmHg and/or diastolic blood pressures ≥100mmHg) before randomization;
• Those with combined active hepatitis B (HBV DNA≥2000 IU/mL or 104 copies/mL), active hepatitis C (HCV-Ab positive and HCV-RNA≥ upper limit of normal value), acquired immune deficiency syndrome (AIDS) or positive HIV test, and positive syphilis test;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

SAHZhejiangU

Hangzhou, Zhejiang, 313000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Lung Neoplasms

Interventions

Palonosetron; dexamethasone acetate; Injections

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

LIPING WANG

CONTACT

18358147489; 2315124@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: June 1, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 1, 2026

Record last verified: 2025-10

Locations

CN (1)