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

ConditionNonsmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • HS-10365 capsules

    Drug

    HS-10365 will be administered orally twice daily until the occurrence of disease progression, unacceptable adverse events, withdrawal of consent, death or the end of the study.

Treatment groups

62 Participants
are divided into 1 treatment group
Group A: HS-10365Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR assessed by IRC

ORR is defined as the percentage of patients with a CR or PR that was confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1.

Time frame
From the date of first occurrence of complete response (CR) or partial response (PR) on 2 consecutive occasions (≥4 weeks), until the date of disease progression or withdrawal from study, whichever came first, up to 48 months.

Secondary outcomes

1

Disease Control Rate (DCR)

Objective response was assessed by RECIST 1.1 thereby to evaluate disease control rate. Disease control was defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 5 weeks).

Time frame
From the first occurrence of confirmed CR or PR or SD until the date of disease progression or withdrawal from study, whichever came first, up to 48 months.
2

Duration of response (DOR)

Duration of response (DOR)

Time frame
From the date of the first dose to disease progression or death in patients who achieve CR or PR, whichever came first, up to 48months.
3

Progression-free survival (PFS)

Progression of tumor was assessed by RECIST 1.1 thereby to evaluate progression free survival. Progression-free survival was defined as the time from date of first dose until the documentation of objective PD or death from any cause in the absence of progression (whichever occurred first), regardless of whether they subsequently received non-study anti-cancer therapy.

Time frame
From the date of the first dose until the date of disease progression or death from any cause, whichever came first, up to 48 months.
4

Overall survival (OS)

Overall survival (OS)

Time frame
The time from initial administration to death from any cause, up to 5 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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