RecruitingPhase 2

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

China62 participantsStarted 2023-09-25

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Treatment with any of the following:
. Inadequate bone marrow reserve or serious organ dysfunction.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ORR assessed by IRC

Timeframe: 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.

Trial details

NCT IDNCT06147570

SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Shun Lu, MD

13601813062 shun_lu@hotmail.com

View on ClinicalTrials.gov More Nonsmall Cell Lung Cancer trials