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Recruiting Phase 2

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

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About this study

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.

Condition
Nonsmall Cell Lung Cancer
Tested
HS-10365 capsules
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 11

  • Minimum age: 18 years
  • Study condition: Nonsmall Cell Lung Cancer
  • Men or women aged more than or equal to (≥) 18 years.
  • 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.
  • A RET gene fusion is required by using tumor tissue for central testing.
  • At least one measurable lesion in accordance with RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0\~1.
  • Estimated life expectancy \>12 weeks.
  • 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.
  • Females must have evidence of non-childbearing potential.
  • Signed and dated Informed Consent Form.

Exclusion 15

  • 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.
  • Inadequate bone marrow reserve or serious organ dysfunction.
  • Uncontrolled pleural effusion or ascites or pericardial effusion.
  • Known and untreated, or active central nervous system metastases.
  • Active autoimmune diseases or active infectious disease
  • Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications.
  • 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.
  • The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.
  • The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.
  • Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.
  • History of neuropathy or mental disorders, including epilepsy and dementia

Where

1 site, 1 recruiting

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.