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

Hanlim Pharm

Status and phase: Unknown; Phase 2

Conditions: Radiation Pneumonitis; Lung Cancer

Treatments: Drug: Placebo of HL301 tablet; Drug: HL301 tablet 300mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04632342

HL_HL301_203

Details and patient eligibility

About

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.

Enrollment: 87 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

• Women of childbearing age or men who do not agree to use a medically accepted method of contraception during the clinical trial

• Pregnant or breast-feeding

• Subjects who have clinical significance that is considered inappropriate for this clinical trial as judged by the investigator

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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87 participants in 3 patient groups, including a placebo group

Experimental group 1

Experimental group

Description:

HL301 1,200mg/day

Treatment:

Drug: HL301 tablet 300mg

Experimental group 2

Experimental group

Description:

HL301 1,800mg/day

Treatment:

Drug: HL301 tablet 300mg

Control group

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo of HL301 tablet