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AzTrials

Chemotherapy-induced Nausea and VomitingPhase 3NCT06331520

NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens

A Phase 3 study testing Netupitant / Palonosetron Oral Capsule [Akynzeo], Olanzapine and Dexamethasone Oral in people with Chemotherapy-induced Nausea and Vomiting and Highly Emetogenic Chemotherapy, run by Fudan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this Prospective, randomized, non inferiority phase III trial is to confirm the efficacy and saftey of dexamethasone-sparing combined with netupitant/palonostron and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Netupitant / Palonosetron Oral Capsule [Akynzeo], Olanzapine and Dexamethasone Oral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
644 participants
Where
1 siteChina
Study dates
1 May 2024to 30 Aug 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients ≥18 years old
  • Patients who receive the high-emetic-risk anticancer agents.
  • Patients who do not take a medicine, for example, 5HT3 receptor antagonists, NK1 receptor antagonists, or research related agents, within 3 weeks prior to enrollment.
  • No nausea or vomiting (grade II or above) within 72 hours before the start of chemotherapy.
  • Subject has Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Subject has a life Expectation of at least 12 weeks.
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  • In accordance with the indication of chemotherapy and basic requirements： Peripheral haematology: Hb ≥9.0g/dL; absolute neutrophil count ≥1.5×109/L; Platelet count ≥80×109/L Blood biochemistry: Total bilirubin < 1.25×ULN, ALT and AST ≤ 2.5×ULN; If liver metastasis, ALT and AST < 5×ULN, Creatinine ≤ 1×ULN, basic normal serum electrolyte (Na, Ka, Cl, Ca) Other important organs function normally.
  • Female patients of either non-childbearing potential or child-bearing potential use contraceptive methods throughout the clinical trial.
  • Female patients with child-bearing potential must is negative of pregnancy test.
  • Subjects voluntarily and strictly comply with the research protocol requirements and sign a written informed consent
  • Subjects can independently fill out patient diaries.

Who cannot join

  • Patients receiving moderate or high emetic radioation therapy within 1 week before chemotherapy or day 1 to 5 after chemotherapy.
  • Within 24 hours after chemotherapy, patients receiving any known or potential antiemetic agents and appearing symptoms vomiting, nausea, or mild nausea symptoms.
  • Scheduled to receive inducer or substrate or strong / moderate inhibitor of cytocrome P450 3A4 (CYP3A4) within 3 weeks prior to day 1.
  • Patients who cannot tolerate chemotherapy drugs.
  • Serious cardiovascular, pulmonary disease, diabetes, mental and other diseases.
  • Pregnant , breastfeeding and woman with child-bearing potential who are unwilling or unable to take effective contraceptive measures.
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  • Drug addict or alcohol abuse.
  • Hypocalcemia or any other condition that may cause vomiting.
  • Patients has significant factors that affect the absorption of oral medication, such as chronic diarrhea or obstruction.
  • Subjects has hypersensitivity to netupitant/palonostron capsules or any of its excipients.
  • Scheduled to receive any antiemetic agents within 3 weeks prior to day 1(including but not limited to: neurokin-1 (NK1) receptor antagonist, 5-HT3 receptor antagonists, olanzapine, scopolamine,et al.).
  • Scheduled to receive benzodiazepine, opioid or opioid derivatives (except midazolam, temazepam or triazolam)within 1 week before chemotherapy or day 1 to 5 after chemotherapy.
  • Subjects are currently enrolled in an other clinical study with any other clinical trials, investigational drugs or observational studies within 21 days of baseline.
  • Investigators judged other situations that may affect the progress and results of clinical research.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Cancer

    Shanghai, Shanghai Municipality, 200043

Other trials in China

About this study

Official title: Dexamethasone-sparing Based on Netupitant/Palonosetron(NEPA) With Olanzapine for the Effect of Chemotherapy-induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy: a Randomized Noninferiority III Phase Trial

The objective of this Prospective, randomized, non inferiority phase III trial is to confirm the efficacy and saftey of dexamethasone-sparing combined with netupitant/palonostron and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.

Being tested
Netupitant / Palonosetron Oral Capsule [Akynzeo], Olanzapine, Dexamethasone Oral
Medical subject headings
Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Netupitant / Palonosetron Oral Capsule [Akynzeo]Drug

    Akynzeo is the fixed-combination antiemetic comprising netupitant (neurokinin-1 receptor antagonist [NK1 RA]) and palonosetron (5-hydroxytryptamine-3 receptor antagonist [5-HT3 RA]).

  • OlanzapineDrug

    Olanzapine is an effective antipsychotic drug used in psychiatry to treat psychoses, especially schizophrenia and schizoaffective disorders. It belongs to the 2nd generation antipsychotics, its mechanism of action ranks among multireceptor antagonists (MARTA); it affects the dopamine, serotonin, adrenaline, histamine, and muscarinic systems.

  • Dexamethasone OralDrug

    synthetic glucocorticoids

Study groups in NCT06331520
Study groupRoleWhat they receive
NEO-DXMS GROUPActive comparatorNEPA(1 capsule, day1, PO)+ Olanzapine(5mg, day1-4, PO)+ dexamethasone(12mg, day1; 8mg day2-4, PO/IV).
Receives: Drug: Netupitant / Palonosetron Oral Capsule [Akynzeo]; Drug: Olanzapine; Drug: Dexamethasone Oral
HALF-DXMS GROUPActive comparatorNEPA(1 capsule, day1, PO)+ Olanzapine(5mg, day1-4, PO)+ dexamethasone(6mg, day1, PO/IV)
Receives: Drug: Netupitant / Palonosetron Oral Capsule [Akynzeo]; Drug: Olanzapine; Drug: Dexamethasone Oral
NEO GROUPExperimentalNEPA(1 capsule, day1, PO)+ Olanzapine(5mg, day1-4, PO).
Receives: Drug: Netupitant / Palonosetron Oral Capsule [Akynzeo]; Drug: Olanzapine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with complete response (CR)

    Percentage of patients with complete response (CR) defined defined as no vomiting with no use of rescue therapy

    Measured: Within 0-120 hours from the initiation of chemotherapy

Secondary outcomes (5)

  1. Percentage of Patients With CR (acute and delayed)

    Percentage of patients with complete response (CR) defined defined as no vomiting with no use of rescue therapy "Acute"period referred to 0-24 h after the initiation of chemotherapy,"delayed"period referred to 24-120 h.

    Measured: From the initiation of chemotherapy infusion(0h)up to beginning of day 6(-120 h)

  2. Percentage of patients with overall complete protection(OCP)

    Percentage of patients with overall complete protection(OCP) defined as no emesis, no rescue medication and able mild nausea(VAS≤25mm).

    Measured: During the acute (within 24 hours post-chemotherapy) and delayed (days 2 thorough 5) phases of chemotherapy

  3. Percentage of patients with overall total control (OTC)

    Percentage of patients with overall total control (OTC) defined as no emesis, no rescue medication and no nausea(VAS≤5mm).

    Measured: During 0 ~ 24 hours and 0 ~ 168 hours post-chemotherapy

  4. incidence of adverse events

    Adverse event s were graded according to NCI CTCAE v 5.0

    Measured: From initiation of chemotherapy to 168 hours after initiation of chemotherapy

  5. quality of life questionnaire

    Quality of life(QoL) was evaluated by the Chinese version of the self reported Functional Living Index-Emesis (FLIE) questionnaire by individual patients.

    Measured: From initiation of chemotherapy to 168 hours after initiation of chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2024
  2. Study start1 May 2024
  3. Primary completion1 Aug 2025
  4. Study completion30 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
644 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06331520
Sponsor's protocol ID
Desineo
Status last verified
Apr 2026
First submitted
29 Jan 2024
Last updated
9 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Meng Y, Liu Y, Lin M, Wang L, Mu Y, Yang L, Du Y, Liu X, Chen Y, Tian S, Zhou Q, Zhuang X, Li Z, Liu J, Fang S, Fan W, Mao Y, Zhang L, Wu H, Yan F, Weng J, Zhao J, Long X, Liu L, Zhou J, Zhang J. Reduced/No Dexamethasone With Netupitant/Palonosetron and Olanzapine for Chemotherapy-Induced Nausea/Vomiting in Highly Emetogenic Chemotherapy: Phase III Noninferiority Trial. J Clin Oncol. 2026 Sep;44(25):2390-2399. doi: 10.1200/JCO-26-01029. Epub 2026 Jun 4.

    PubMed 42241642

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Netupitant / Palonosetron Oral Capsule [Akynzeo], Olanzapine and Dexamethasone Oral in people with Chemotherapy-induced Nausea and Vomiting and Highly Emetogenic Chemotherapy, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with complete response (CR) (time frame: Within 0-120 hours from the initiation of chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06331520, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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