A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Launched by JIANGSU HANSOH PHARMACEUTICAL CO., LTD. · Nov 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HS-10365, which is designed to help patients with a specific type of lung cancer known as advanced or metastatic non-small cell lung cancer (NSCLC) that has a genetic change called RET fusion. The main goal of the study is to see how effective and safe this medication is for patients who have not received any prior systemic treatments. If you are a man or woman over 18 years old with this type of lung cancer, and your disease is advanced enough that surgery isn’t an option, you may be eligible to participate in this trial.

Participants in the study can expect to take HS-10365 orally, which means you would swallow it in pill form. The trial will assess how well the drug works and monitor any side effects you might experience. It’s important to note that women of childbearing age must agree to use contraception during the study and for six months afterward, and you should not be breastfeeding. The study is currently recruiting participants, so if you or someone you know fits the eligibility criteria, it could be an opportunity to explore a new treatment option.

Gender

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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