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

Phase 2

• Conditions: Lung Cancer; Radiation Pneumonitis
• Interventions: Drug: HL301 tablet 300mg; Drug: Placebo of HL301 tablet

• Registration Number: NCT04632342
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study Start: 2020-11
• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-13
• Last Update Submitted: 2020-11-13
• Study First Posted: 2020-11-17
• Last Update Posted: 2020-11-17
• Primary Completion: 2022-01
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group 2	HL301 tablet 300mg	HL301 1,800mg/day
Control group	Placebo of HL301 tablet	Placebo
Experimental group 1	HL301 tablet 300mg	HL301 1,200mg/day

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with radiation pneumonia of ≥ Grade 2	up to 24 weeks after completion of radiotherapy	Percentage of subjects with radiation pneumonia of ≥ Grade 2 evaluated by CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
The incidence of radiation pneumonia	p to 24 weeks after completion of radiotherapy	The incidence of radiation pneumonia
Severity at the first diagnosis of radiation pneumonia	up to 24 weeks after completion of radiotherapy	Severity at the first diagnosis of radiation pneumonia evaluated by CTCAE v5.0
Lung volume reduction	at 24 weeks after completion of radiotherapy	Lung volume reduction
Percentage of subjects with radiation pneumonia of ≥ Grade 3	up to 24 weeks after completion of radiotherapy	Percentage of subjects with radiation pneumonia of ≥ Grade 3 evaluated by CTCAE v5.0
Maximum severity of radiation pneumonia	up to 24 weeks after completion of radiotherapy	Maximum severity of radiation pneumonia evaluated by CTCAE v5.0
Changes in lung function	at 4 weeks and 12 weeks after completion of radiotherapy	Changes in lung function (FEV1, DL CO) at each time point after administration compared to before administration of investigational products
Lung fibrosis area	at 24 weeks after completion of radiotherapy	Lung fibrosis area
The incidence of pulmonary fibrosis	at 24 weeks after completion of radiotherapy	The incidence of pulmonary fibrosis
Pulmonary toxicity grade	at the time of initial diagnosis of radiation pneumonia after completion of radiotherapy	Pulmonary toxicity grade evaluated by Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity
The maximum grade of lung toxicity	up to 24 weeks after completion of radiotherapy	The maximum grade of lung toxicity evaluated by RTOG Acute radiation morbidity

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of