To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
NCT ID:
NCT06147570
Condition:
Nonsmall Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HS-10365 capsules
Description:
HS-10365 will be administered orally twice daily until the occurrence of disease
progression, unacceptable adverse events, withdrawal of consent, death or the end of the
study.
Arm group label:
HS-10365
Summary:
HS-10365 is a small molecular, oral potent, selective RET inhibitor. The purpose of this
study is to investigate the efficacy and safety of HS-10365 in Chinese advanced RET
fusion-positive non-small cell lung cancer patients without any systemic therapy.
Detailed description:
This is an open-label, single arm, multi-center Phase 2 study in participants with
treatment-naïve locally advanced or metastatic RET fusion-positive non-small cell lung
cancer, which is designed to investigate the anti-tumor activity, safety and
pharmacokinetics (PK) of HS-10365 at the recommended phase 2 dose (RP2D). HS-10365 will
be administered orally twice daily until the occurrence of disease progression,
unacceptable adverse events, withdrawal of consent, death or the end of the study.
Primary endpoint is objective response rate (ORR) by Independent Reading Committee (IRC).
Secondary and exploratory objectives include evaluation of secondary efficacy endpoints,
safety and PK in the study population.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Men or women aged more than or equal to (≥) 18 years.
2. Histologically or cytologically confirmed diagnosis of locally advanced or
metastatic NSCLC with RET fusion-positive, including recurrent or initial diagnosed
Stage IIIB-IIIC/IV NSCLC that is not suitable for radical surgery.
3. A RET gene fusion is required by using tumor tissue for central testing.
4. At least one measurable lesion in accordance with RECIST 1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status: 0~1.
6. Estimated life expectancy >12 weeks.
7. Reproductive-age women agree to use adequate contraception and cannot breastfeed
while participating in this study and for a period of 6 months after the last dose.
Likewise, men also consent to use adequate contraceptive method within the same time
limit.
8. Females must have evidence of non-childbearing potential.
9. Signed and dated Informed Consent Form.
Exclusion Criteria:
1. Treatment with any of the following:
Additional validated oncogenic drivers in NSCLC if known. Previous or current
treatment with selective RET inhibitors or multi-kinase Inhibitor of RET.
Prior systemic therapy for metastatic disease. Treatment (including chemotherapy or
immunotherapy) in the adjuvant/neoadjuvant setting is permitted if it was completed
at least 6 months prior to relapse.
Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or
patients received more than 30% of the bone marrow irradiation, or large-scale
radiotherapy within 4 weeks of the first dose.
Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4
weeks of the first dose of study drug.
2. Inadequate bone marrow reserve or serious organ dysfunction.
3. Uncontrolled pleural effusion or ascites or pericardial effusion.
4. Known and untreated, or active central nervous system metastases.
5. Active autoimmune diseases or active infectious disease
6. Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to
swallow oral medications.
7. History of severe allergic reaction, hypersensitivity to any active or inactive
ingredient of HS-10365 or to drugs with a similar chemical structure or class to
HS-10365.
8. The subject who is unlikely to comply with study procedures, restrictions, or
requirements judged by the investigator.
9. The subject whose safety cannot be ensured or study assessments would be interfered
judged by the investigator.
10. Pregnant women, breastfeeding women or woman who has a child-bearing plan during the
study.
11. History of neuropathy or mental disorders, including epilepsy and dementia
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Shun Lu, MD
Phone:
13601813062
Email:
shun_lu@hotmail.com
Start date:
September 25, 2023
Completion date:
August 31, 2028
Lead sponsor:
Agency:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06147570
