Not Yet RecruitingPhase 2

First-line Therapy With EGFR-TKI Combined With Trastuzumab Rezetecan for Advanced NSCLC Harboring EGFR Mutations Concomitant With HER2 Alterations

35 participantsStarted 2026-07-09

Plain-language summary

To explore the efficacy and safety of first-line EGFR-TKI combined with Trastuzumab Rezetecan in advanced NSCLC patients harboring EGFR mutations with concomitant HER2 genomic alterations or HER2 protein expression (1+/2+/3+)

Who can participate

Age range

18 Years – 75 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

. Aged 18-75 years, male or female without restriction;
. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1; Estimated survival time ≥ 3 months;
. Histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC);
. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1);
. No prior systemic anti-tumor therapy before enrollment (oral EGFR-TKI administered within 2 weeks prior to screening is permitted);
. Confirmed EGFR mutations via genetic testing, including Exon 19 deletion or L858R point mutation;
. Presence of HER2 alterations, any of the following subtypes is acceptable: confirmed HER2 mutations or amplification by genetic testing; HER2 low expression or overexpression by immunohistochemistry (IHC 1+/2+/3+);
. Adequate laboratory parameters. No blood product transfusion or hematopoietic growth factor support administered within 14 days prior to the first study drug dose to correct lab abnormalities.

Exclusion criteria

. Histologically confirmed tumor containing small cell lung cancer components.

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

Timeframe: 24 months

Trial details

NCT IDNCT07699952

SponsorYongsheng Wang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-03

Contact for this trial

Xue Chen

18228971317 xue.chen.xc353@hengrui.com

View on ClinicalTrials.gov More Lung Cancer (NSCLC) trials