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OncoMatch/Clinical Trials/NCT06147570

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

Is NCT06147570 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies HS-10365 capsules for nonsmall cell lung cancer.

Phase 2RecruitingJiangsu Hansoh Pharmaceutical Co., Ltd.NCT06147570Data as of May 2026

Treatment: HS-10365 capsulesHS-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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: RET fusion

Disease stage

Required: Stage IIIB, IIIC, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: selective RET inhibitor

Previous or current treatment with selective RET inhibitors

Cannot have received: multi-kinase inhibitor of RET

Previous or current treatment with ... multi-kinase Inhibitor of RET

Cannot have received: systemic therapy

Exception: adjuvant/neoadjuvant therapy completed at least 6 months prior to relapse

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.

Lab requirements

Blood counts

adequate bone marrow reserve required

Inadequate bone marrow reserve or serious organ dysfunction [excluded].

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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