Efficacy and safety of oral granisetron and dexamethasone for crizotinib-induced nausea and vomiting in patient with non-small cell lung cancer

Efficacy and safety of oral granisetron and dexamethasone for crizotinib-induced nausea and vomiting in patient with non-small cell lung cancer - CROWN study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031180378

Enrollment

Registered

2019-03-19

Start date

2015-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non small cell lung cancer ALK or ROS1 fusion gene

Interventions

oral granisetron and dexamethasone for crizotinib-induced nausea and vomiting

D000932

Crizotinib, Granisetron, dexamethasone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. histologically or cytologically confirmed NSCLC 2. diagnosed with ALK or ROS1 fusion gene 3. planned to treat with Crizotinib within 2 weeks 4. 20years old or older 5. possible to oral intake 6. ECOG PS 0-2 7. adequate organ function 8. Written informed consent

Exclusion criteria

Exclusion criteria: 1. medical history of severe allergy 2. symptomatic brain metastasis 3. medical history of seizure and who need epilepsy drug 4. gastrointestinal obstruction 5. pregnant, breast-feeding, and childbearing potential 6. diagnosed with interstitial lung disease or pulmonary fibrosis by chest CT 7. difficult to registration due to mental illness 8. systemic steroid administration (oral or intravenous) 9. started to treat with opioid for pain control within 7days before registration 10. vomiting and/or more than Gr2 nausea (CTCAE) within 72 hours after registration 11. impossible to record medical diary 12. no prior Crizotinib 13. assessed unsuitable to this study by attending doctor because of any other reason

Design outcomes

Primary

Measure	Time frame
Complete response rate of control vomiting within 120 hours (day1-5) from the start of administration of Crizotinib	—

Secondary

Measure	Time frame
Complete response rate of control vomiting (day6-14) Complete control rate of vomiting (day1-5 and day6-14) Total control rate of nausea and vomiting (day1-5 and day6-14) Time to treatment failure which ever come earlier first vomiting or rescue usage of antiemetic drugs	—

Contacts

Public ContactKeisuke Kirita

National Cancer Center Hospital East

kkirita@east.ncc.go.jp+81-4-7133-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026