Clinical trial · Interventional
Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of HL301 on Radiation Pneumonitis in Non-small Cell Lung Cancer Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Pneumonitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HL301 tablet 300mg | Drug | — | UNRESOLVED |
| Placebo of HL301 tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Experimental group 1
- description
- HL301 1,200mg/day
- interventionNames
- Drug: HL301 tablet 300mg
- type
- EXPERIMENTAL
- label
- Experimental group 2
- description
- HL301 1,800mg/day
- interventionNames
- Drug: HL301 tablet 300mg
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Placebo
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available