Radiation PneumonitisPhase 2NCT04632342
Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of HL301 on Radiation Pneumonitis in Non-small Cell Lung Cancer Patients
A Phase 2 study testing HL301 tablet 300mg in people with Radiation Pneumonitis and Lung Cancer, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Radiation Pneumonitis, Lung Cancer
- What is being tested?
- HL301 tablet 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2020to Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
Jaeho Cho, 82-2-2228-8113, jjhmd@yuhs.ac
About this study
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
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
- Radiation Pneumonitis, Lung Cancer
- Being tested
- HL301 tablet 300mg, Placebo of HL301 tablet
- Medical subject headings
- Radiation Pneumonitis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL301 tablet 300mgDrug
- Experimental group 1 : 2 tablets at once, twice a day
- Experimental group 2 : 2 tablets at once, three times a day
Placebo of HL301 tabletDrug
2 tablets at once, three times a day
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | HL301 1,200mg/day Receives: Drug: HL301 tablet 300mg |
| Experimental group 2 | Experimental | HL301 1,800mg/day Receives: Drug: HL301 tablet 300mg |
| Control group | Placebo comparator | Placebo Receives: Drug: Placebo of HL301 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with radiation pneumonia of ≥ Grade 2
Percentage of subjects with radiation pneumonia of ≥ Grade 2 evaluated by CTCAE v5.0
Measured: up to 24 weeks after completion of radiotherapy
Secondary outcomes (10)
The incidence of radiation pneumonia
The incidence of radiation pneumonia
Measured: p to 24 weeks after completion of radiotherapy
Percentage of subjects with radiation pneumonia of ≥ Grade 3
Percentage of subjects with radiation pneumonia of ≥ Grade 3 evaluated by CTCAE v5.0
Measured: up to 24 weeks after completion of radiotherapy
Severity at the first diagnosis of radiation pneumonia
Severity at the first diagnosis of radiation pneumonia evaluated by CTCAE v5.0
Measured: up to 24 weeks after completion of radiotherapy
Maximum severity of radiation pneumonia
Maximum severity of radiation pneumonia evaluated by CTCAE v5.0
Measured: up to 24 weeks after completion of radiotherapy
Changes in lung function
Changes in lung function (FEV1, DL CO) at each time point after administration compared to before administration of investigational products
Measured: at 4 weeks and 12 weeks after completion of radiotherapy
The incidence of pulmonary fibrosis
The incidence of pulmonary fibrosis
Measured: at 24 weeks after completion of radiotherapy
Lung fibrosis area
Lung fibrosis area
Measured: at 24 weeks after completion of radiotherapy
Lung volume reduction
Lung volume reduction
Measured: at 24 weeks after completion of radiotherapy
Pulmonary toxicity grade
Pulmonary toxicity grade evaluated by Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity
Measured: at the time of initial diagnosis of radiation pneumonia after completion of radiotherapy
The maximum grade of lung toxicity
The maximum grade of lung toxicity evaluated by RTOG Acute radiation morbidity
Measured: up to 24 weeks after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation PneumonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632342
- Sponsor's protocol ID
- HL_HL301_203
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04632342
- Acronym / sponsor ID
- HL_HL301_203
- Conditions
- Radiation Pneumonitis, Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2020 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Drug: HL301 tablet 300mgHL301 1,200mg/day |
| Experimental group 2 | Experimental | Drug: HL301 tablet 300mgHL301 1,800mg/day |
| Control group | Placebo comparator | Drug: Placebo of HL301 tabletPlacebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HL301 tablet 300mg* Experimental group 1 : 2 tablets at once, twice a day * Experimental group 2 : 2 tablets at once, three times a day | Drug | Experimental group 1, Experimental group 2 |
| Placebo of HL301 tablet2 tablets at once, three times a day | Drug | Control group |
Primary outcome
Percentage of subjects with radiation pneumonia of ≥ Grade 2
Time frame: up to 24 weeks after completion of radiotherapy
Percentage of subjects with radiation pneumonia of ≥ Grade 2 evaluated by CTCAE v5.0
10 secondary outcomes
The incidence of radiation pneumonia
Time frame: p to 24 weeks after completion of radiotherapy
Percentage of subjects with radiation pneumonia of ≥ Grade 3
Time frame: up to 24 weeks after completion of radiotherapy
Severity at the first diagnosis of radiation pneumonia
Time frame: up to 24 weeks after completion of radiotherapy
Maximum severity of radiation pneumonia
Time frame: up to 24 weeks after completion of radiotherapy
Changes in lung function
Time frame: at 4 weeks and 12 weeks after completion of radiotherapy
The incidence of pulmonary fibrosis
Time frame: at 24 weeks after completion of radiotherapy
Lung fibrosis area
Time frame: at 24 weeks after completion of radiotherapy
Lung volume reduction
Time frame: at 24 weeks after completion of radiotherapy
Pulmonary toxicity grade
Time frame: at the time of initial diagnosis of radiation pneumonia after completion of radiotherapy
The maximum grade of lung toxicity
Time frame: up to 24 weeks after completion of radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HL301 tablet 300mg in people with Radiation Pneumonitis and Lung Cancer, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaeho Cho, M.D. (82-2-2228-8113, jjhmd@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with radiation pneumonia of ≥ Grade 2 (time frame: up to 24 weeks after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.