Clinical trial NCT04632342: Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of HL301 on Radiation Pneumonitis in Non-small Cell Lung Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Radiation Pneumonitis
Lung Cancer
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 87
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of subjects with radiation pneumonia of ≥ Grade 2
timeFrame: up to 24 weeks after completion of radiotherapy
Secondary outcomes:
measure: The incidence of radiation pneumonia
timeFrame: p to 24 weeks after completion of radiotherapy
measure: Percentage of subjects with radiation pneumonia of ≥ Grade 3
timeFrame: up to 24 weeks after completion of radiotherapy
measure: Severity at the first diagnosis of radiation pneumonia
timeFrame: up to 24 weeks after completion of radiotherapy
measure: Maximum severity of radiation pneumonia
timeFrame: up to 24 weeks after completion of radiotherapy
measure: Changes in lung function
timeFrame: at 4 weeks and 12 weeks after completion of radiotherapy
measure: The incidence of pulmonary fibrosis
timeFrame: at 24 weeks after completion of radiotherapy
measure: Lung fibrosis area
timeFrame: at 24 weeks after completion of radiotherapy
measure: Lung volume reduction
timeFrame: at 24 weeks after completion of radiotherapy
measure: Pulmonary toxicity grade
timeFrame: at the time of initial diagnosis of radiation pneumonia after completion of radiotherapy
measure: The maximum grade of lung toxicity
timeFrame: up to 24 weeks after completion of radiotherapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References: