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A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib

NCT05204628 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2022-01-24

No results posted yet for this study

Summary

This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of XZP-3621 versus crizotinib and to evaluate the pharmacokinetics of XZP-3621 in Chinese participants with treatment-naive ALK-positive advanced NSCLC. Participants will be randomized 1:1 into one of the two treatment groups to receive either XZP-3621 (500 milligrams \[mg\] once daily \[QD\]) or crizotinib (250 mg BID) orally, respectively.

Conditions

Interventions

DRUG

XZP-3621

XZP-3621 tablets will be administered orally at a dose of 500 mg QD until disease progression, unacceptable toxicity withdrawal of consent, or death, whichever occurred first.

DRUG

Crizotinib

Crizotinib capsules will be administered orally at a dose of 250 mg BID until disease progression, unacceptable toxicity withdrawal of consent, or death, whichever occurred first.

Sponsors & Collaborators

  • Xuanzhu Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ying Cheng, MD · Jilin Province Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2025-05-07
Completion
2025-07-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05204628 on ClinicalTrials.gov