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A Study to Evaluate Safety and Efficacy of HS-10296 as First-Line Treatment in Patients

NCT03849768 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 429

Last updated 2023-01-20

Study results available
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Summary

This is a randomized, controlled, double-blind, multicenter, phase III clinical study.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

HS-10296

Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

DRUG

Gefitinib

Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Maniam Ajit, MD · Pacific Cancer Medical Center, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2021-01-15
Completion
2023-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT03849768 on ClinicalTrials.gov