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

NCT04632342 | Unknown Phase 2

• 1 other identifier: HL_HL301_203
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with radiation pneumonia of ≥ Grade 2

  Percentage of subjects with radiation pneumonia of ≥ Grade 2 evaluated by CTCAE v5.0

  up to 24 weeks after completion of radiotherapy

Secondary Outcomes (10)

• The incidence of radiation pneumonia

  p to 24 weeks after completion of radiotherapy

• Percentage of subjects with radiation pneumonia of ≥ Grade 3

  up to 24 weeks after completion of radiotherapy

• Severity at the first diagnosis of radiation pneumonia

  up to 24 weeks after completion of radiotherapy

• Maximum severity of radiation pneumonia

  up to 24 weeks after completion of radiotherapy

• Changes in lung function

  at 4 weeks and 12 weeks after completion of radiotherapy

Study Arms (3)

Experimental group 1

EXPERIMENTAL

HL301 1,200mg/day

Drug: HL301 tablet 300mg

Experimental group 2

EXPERIMENTAL

HL301 1,800mg/day

Drug: HL301 tablet 300mg

Control group

PLACEBO COMPARATOR

Placebo

Drug: Placebo of HL301 tablet

Interventions

HL301 tablet 300mg DRUG

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

Experimental group 1; Experimental group 2

Placebo of HL301 tablet DRUG

2 tablets at once, three times a day

Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, age ≥ 19 years
• Stage III non-small cell lung cancer(NSCLC) patient who without surgical treatment
• Patients scheduled for curative concurrent chemoradiotherapy
• chemotherapy : paclitaxel and carboplatin
• radiation therapy : IMRT, total 60\~70Gy
• Eastern Cooperative Oncology Group(ECOG) performance status of 0 to 2 at the screening visit
• Subject whose remaining life expectancy is more than 6 months according to the judgment of investigator
• Volunteer, be willing and able to provide written informed consent for the trial

You may not qualify if:

• Subjects with pleural effusion
• Subjects with a weight loss of 10% or more within the last 6 months from the screening visit
• Subjects with a history of thoracic or neck radiotherapy or chemotherapy prior to screening visit
• Subjects with distant metastases
• Subjects with liver/renal dysfunction according to the following criteria on the screening test
• Total Bilirubin \>1.5 mg/dL
• ALT or AST level is 2.0 times higher than the upper limit of normal (based on the institution)
• Serum Creatinine \>1.5 mg/dL
• Subjects with serious cardiovascular disease within 3 months prior to the screening visit (ex. arrhythmia, congestive heart failure, infarction, unstable angina etc)
• Subjects with serious systemic infection (≥ Grade 3, evaluated by CTCAE v5.0)
• Patients with chronic or interstitial lung disease (excluding patients with chronic obstructive pulmonary disease (COPD)), patients with chronic bronchitis, patients with pneumonia
• Subjects with thyroid dysfunction as present illness at the screening visit
• Subjects who administered systemic steroids within 4 weeks prior to the date of randomization (except for cases when administered to prevent hypersensitivity reaction of paclitaxel)
• Subjects who are hypersensitive to investigational products and standard anticancer treatments
• Subjects who participate in other clinical trials within 30 days prior to the screening visit and administer investigational drugs or apply clinical trial medical devices

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Radiation Pneumonitis; Lung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Radiation Injuries; Wounds and Injuries; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Jaeho Cho, M.D.

CONTACT

82-2-2228-8113; jjhmd@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 17, 2020
• Study Start: November 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

KR (1)