Lung Cancer, Radiation Pneumonitis
Conditions
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.
Interventions
DRUGHL301 tablet 300mg
* Experimental group 1 : 2 tablets at once, twice a day * Experimental group 2 : 2 tablets at once, three times a day
DRUGPlacebo of HL301 tablet
2 tablets at once, three times a day
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| The incidence of radiation pneumonia | p to 24 weeks after completion of radiotherapy | The incidence of radiation pneumonia |
| Lung fibrosis area | at 24 weeks after completion of radiotherapy | Lung fibrosis area |
| Lung volume reduction | at 24 weeks after completion of radiotherapy | Lung volume reduction |
| 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 |
| The incidence of pulmonary fibrosis | at 24 weeks after completion of radiotherapy | The incidence of pulmonary fibrosis |
Countries
South Korea
Contacts
Primary ContactJaeho Cho, M.D.
Outcome results
None listed