Open Menu
Meetings & Education
Meetings & Education
Research & Data
Practice & Patients
Career Development
News & Initiatives
Get Involved
A multicenter, open-label, single-arm phase I/II study to assess the efficacy and safety of WSD0922-FU in patients with EGFR C797Sm+ advanced non-small cell lung cancer (NSCLC) in China (NCT06631989).
Background:
Although 3rd-generation EGFR TKIs, such as Osimertinib, Almonertinib, Furmonertinib, Befotertinib etc. are highly effective in front-line metastatic EGFR-mutated ( EGFR m) NSCLC, treatment resistance ultimately occurs, including the emergence of the on-target C797S mutation for which there are no approved TKIs. WSD0922-FU is an oral, central nervous system (CNS)-penetrant, wildtype-sparing, ATP non-competitive, reversible EGFR inhibitor targeting EGFR aberrations in NSCLC and High-Grade Astrocytoma. It has shown promising preclinical and clinical data, including antitumor CNS activity that may improve patient outcomes. Additionally, combining WSD0922-FU with standard therapies may provide enhanced disease control across multiple lines of treatment, including against heterogenous tumors, in patients with EGFR m+ NSCLC. WSD0922-102 (NCT06631989) is an ongoing phase 1/2, open-label, multicenter trial evaluating the efficacy and safety of WSD0922-FU in patients with EGFR C797Sm+ NSCLC in China.
Methods:
Adult patients with EGFR C797Sm+ NSCLC were initially treated with oral WSD0922-FU, with three doses selected from phase I dose escalation (MC1914, NCT04197934) as a bridging PK study in China. After DLT evaluation, expansion was initiated for each dose followed by extension for the dose selected as the recommended phase 2 dose (RP2D). Key inclusion criteria include patients ≥18 years of age with metastatic EGFR C797Sm+ NSCLC; Eastern Cooperative Oncology Group performance status 0–1; and failed in the previous 3rd generation EGFR-targeted TKI treatment for bridging PK study, with only one 3rd generation EGFR TKI for expansion and with only one first-line 3rd generation EGFR TKI for extension. All patients must harbor an EGFR C797S resistance mutation (locally assessed for tissue/liquid samples). Key exclusion criteria are tumors harboring EGFR T790M mutations, EGFR exon 20 insertions, or MET aberrations. Dose escalation primary endpoints are maximum tolerated dose, RP2D and safety. The expansion and extension primary endpoints are overall response rate (ORR) by RECIST 1.1. Secondary endpoints include ORR (dose escalation), duration of response, disease control rate, progression-free survival, overall survival, antitumor CNS activity (iORR) by RANO-BM, and safety (dose expansion and extension). The phase 1 dose escalation adopts a 3+3 design. Patients will be enrolled into 3 treatment cohorts: dose escalation (n≈12-15), dose expansion (n≈20), and dose extension (n≈70). Patients may receive treatment until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Enrollment in this study for dose expansion cohorts is ongoing and 15 sites are open across China. Clinical trial information: NCT06631989.
Disclaimer
This material on this page is ©2025 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Author Details
Wei Zhong
Wayshine Biopharm Inc., Corona, CA
Authors chevron_right
Associated Organizations chevron_right
Abstract Details
Meeting
2025 ASCO Annual Meeting
Session Type
Poster Session
Session Title
Lung Cancer—Non-Small Cell Metastatic
Track
Lung Cancer
View MoreAbstract Disclosure
open_in_new
Your Privacy
ASCO is committed to transparency regarding our websites and the ways we process data. When you visit our site, we may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences, your location, or your device and is mostly used to make the site work as you expect it to and to personalize your web experience with us.
Because we respect your right to privacy, you can choose not to allow some or all types of cookies. Click on the different category headings to find out more about the types of cookies used on our websites and change your default settings to match your preferences. Please read these carefully. Blocking some types of cookies may impact your experience on the site, including our ability to personalize the content you receive from us.
For a full explanation of the personal and non-personal information we collect on our site, including how we use that information and your rights regarding that information, please review our Privacy Policy. Use of our website is also subject to our Terms of Use.
Allow All
Manage Consent Preferences
Essential Website Cookies
Always Active
These cookies are necessary for the website to function and are sometimes referred to as “strictly necessary” cookies. They make sure the website delivers you information and services in an optimal way.
They are often set in response to an action you take, such as changing your cookie preferences, setting your privacy preferences, logging in to our website, asking the site to remember you on subsequent pages, or filling in forms. These cookies do not identify you personally.
You can set your browser to block or alert you about all cookies, including essential website cookies, but some parts of the site will not work as a result.
Cookies Details
Performance and Functionality Cookies
Performance and Functionality Cookies
These cookies enhance the performance and functionality of our websites and the services we provide. For example, these cookies can keep track of your visitor session in between visits, enable you to share content through social media, use embedded media players, and use comment features. They also help us balance website load and improve site speed and performance.
All information these cookies collect is aggregated and therefore anonymous. These cookies may be set by us or by third party providers whose services we have added to our websites. These cookies are non-essential, but without these cookies, certain functionality or enhanced features may become unavailable.
Cookies Details
Personalization and Analytics Cookies
Personalization and Analytics Cookies
These cookies collect information that is used to help us understand how our websites and content are used, help us customize our websites and application for you in order to enhance your experience, and help us improve the content that ASCO creates to better meet our members’ and visitors’ needs. Examples include cookies that show us which content might be most popular with our visitors, understand browsing history of our users, understand the effectiveness of our own advertising, and enable us to recommend content to individual users based on their profile and activities on the website.
These cookies may be set by us or by third party providers whose services we have added to our websites.
These cookies are non-essential to the functionality of the site and may contain information that enables us or our third party providers to identify you and build a profile of your interests. Without these cookies, you will not be able to have a customized or personalized experience within our website.
Cookies Details
Advertising Cookies and Social Media Cookies
Advertising Cookies and Social Media Cookies
Advertising (or Targeting) cookies are third party cookies that may be set through our site by our advertising partners. They may be used by those companies to build a profile of your interests and show you relevant ads on other sites.
Social Media Cookies are cookies set by a range of social media services that we have added to the site to enable you to share our content with your friends and networks. They are capable of tracking your activities across other sites and building a profile of your interests. This may impact the content and messages you see on other websites you visit.
These cookies and the data collected by the third parties may be combined with data from other users or data about your activity on other sites. While the data collected on our site is aggregate or non-personal, the data may be used by such third parties to link you on other platforms or otherwise identify you.
If you do not allow these cookies, you may experience less targeted advertising.
Cookies Details
Back Button
Cookie List
Search Icon
Filter Icon
Clear
checkbox labellabel
ApplyCancel
ConsentLeg.Interest
checkbox labellabel
checkbox labellabel
checkbox labellabel
View Cookies
Name
cookie name
Save Settings
Download