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Abivertinib Maleate Versus Geifitinib in Patients With Advanced Non-small Cell Lung Cancer With Sensitive EGFR Mutation

NCT03856697 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2019-02-27

No results posted yet for this study

Summary

To compare efficacy and safety of Abivertinib maleate alone versus standard first-line EGFR-TKIs for the treatment of patients with advanced non-small cell lung cancer with sensitive EGFR mutation

Conditions

Interventions

DRUG

Abivertinib Maleate Capsules

patients receive the test drug (Abivertinib maleate Capsules) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 3 capsules, and the second dose is 3 capsules. The drugs should be administered with water before or after meals.

DRUG

Placebo Gefitinib Tablets

patients receive the test drug (Placebo Gefitinib Tablets) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 1 tablet. The drugs should be administered with water before or after meals.

DRUG

Gefitinib Tablets

patients receive the control drug (Gefitinib Tablets) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 1 tablet. The drugs should be administered with water before or after meals.

DRUG

Placebo Abivertinib Maleate Capsules

patients receive the control drug (Placebo Abivertinib Maleate Capsules) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 3 capsules, and the second dose is 3 capsules. The drugs should be administered with water before or after meals.

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Hangzhou ACEA Pharmaceutical Research Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yilong Wu, MD · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2022-03-31
Completion
2024-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT03856697 on ClinicalTrials.gov