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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 (Jun 2026). This Phase 2 trial studies HS-10365 capsules for nonsmall cell lung cancer.

Phase 2RecruitingJiangsu Hansoh Pharmaceutical Co., Ltd.NCT06147570Data as of Jun 2026Location: China

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

Treatments studied

Other

HS-10365 capsules

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.

Frequently asked questions

Is NCT06147570 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require RET?

Yes, RET fusion is a required biomarker for enrollment.

What disease stage is eligible?

Stage IIIB or IIIC or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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