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Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of HL301 on Radiation Pneumonitis in Non-small Cell Lung Cancer Patients

NCT04632342 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2020-11-17

No results posted yet for this study

Summary

The purpose of this clinical trial is to evaluate the safety when HL301 is administered to unresectable non-small cell lung cancer patients who receive chemoradiotherapy with Paclitaxel and Carboplatin and to search for a clinically appropriate dose by evaluating the efficacy by comparing the radiation pneumonia incidence rate with the control group.

Conditions

Interventions

DRUG

HL301 tablet 300mg

* Experimental group 1 : 2 tablets at once, twice a day * Experimental group 2 : 2 tablets at once, three times a day

DRUG

Placebo of HL301 tablet

2 tablets at once, three times a day

Sponsors & Collaborators

  • Hanlim Pharm. Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2022-01-31
Completion
2022-02-28

Countries

  • South Korea

Study Locations

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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 NCT04632342 on ClinicalTrials.gov