NCT04632342

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

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo on Radiation Pneumonitis in Unresectable Non-small Cell Lung Cancer Patients Treated With Curative Concurrent Chemoradiotherapy Using Paclitaxel and Carboplatin

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

• Radiation Pneumonitis
• Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-01-01
• Completion: 2022-02-01
• First posted: 2020-11-17
• Last updated: 2020-11-17

Locations

1 site across 1 country: South Korea