NCT06147570 A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
| NCT ID | NCT06147570 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Condition | Nonsmall Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2023-09-25 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 62 participants in total. It began in 2023-09-25 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Shun Lu, MD
PRINCIPAL INVESTIGATOR
Shanghai Chest Hospital
Frequently Asked Questions
Who can join the NCT06147570 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nonsmall Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06147570 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06147570 currently recruiting?
Yes, NCT06147570 is actively recruiting participants. Contact the research team at shun_lu@hotmail.com for enrollment information.
Where is the NCT06147570 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06147570 clinical trial?
NCT06147570 is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. The principal investigator is Shun Lu, MD at Shanghai Chest Hospital. The trial plans to enroll 62 participants.
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