Clinical trial Recruiting at 12 sites Phase1; Phase2 Interventional Ages 18 to 75

Assessing WSD0922-FU for advanced lung cancer with specific mutations

Official title: A Phase I/II Multicenter, Open Label, Single-arm Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of WSD0922-FU in the Treatment of Advanced Non-small Cell Lung Cancer

Run by Wayshine Biopharm, Inc. · NCT06631989 · Data updated 2026-11-12

This study is testing a new treatment called WSD0922-FU for patients in China with advanced lung cancer who have a specific mutation and haven't responded to standard therapies.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment100 (estimated)
SponsorWayshine Biopharm, Inc.
Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy
Locations12 sites (Hefei, Anhui and 11 other locations)
StatusRecruiting
StartedSeptember 4, 2024
Main results expectedJune 30, 2027
Study endsDecember 31, 2027
Registry record updatedAugust 29, 2025
Trial IDNCT06631989 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-75 with advanced NSCLC confirmed by pathology and carrying the EGFR C797S mutation after progression on third-generation EGFR-TKIs.

Probably not a fit

Patients without the EGFR C797S mutation or those who have not progressed after first-line EGFR-TKI therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label, single-arm phase I/II clinical study evaluates the safety, tolerability, pharmacokinetics, and efficacy of WSD0922-FU in patients with advanced non-small cell lung cancer (NSCLC) who have the C797S mutation and have experienced resistance to first-line third-generation EGFR-TKI therapies. The study is conducted in China and consists of two parts: a dose escalation and expansion study, followed by a dose extension phase. Participants will receive WSD0922-FU and will be monitored for treatment outcomes and side effects.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced NSCLC who have developed resistance to existing EGFR-TKI therapies.

How similar studies have gone: While there have been studies on EGFR mutations and targeted therapies, this specific approach with WSD0922-FU in the context of C797S mutation resistance is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age 18-75 years old (including the threshold value), gender is not limited;
* Locally advanced or metastatic NSCLC confirmed by pathology;
* Patients who have been genetically tested to carry EGFR sensitive mutations;
* Blood samples must be provided for testing and must be taken during or after disease progression following the last EGFR TKI inhibitor treatment;
* Must have a minimum life expectancy of \>= 3 months;
* At least one measurable tumor lesion according to RECIST version 1.1; Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions.
* Physical Status (ECOG PS) score was 0-1;
* Have full organ function;
* Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method ;
* Subjects are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily.

Exclusion Criteria:

* Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug.
* Have previously received more than one EGFR-TKI inhibitor;
* Received other unlisted clinical study drugs or treatments within 4 weeks before the first administration.
* Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period.
* Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drug.
* Known active brain metastasis or progression evidence.
* Other primary malignant tumors within 2 years before the first administration of the study drug.
* Adverse reactions from previous anti-tumor treatments have not recovered to NCI-CTCAE v5.0 grade ≤1 (except for toxicities judged by the researcher to have no safety risks, such as hair loss, grade 2 peripheral neurotoxicity, and stable thyroid function after hormone replacement therapy).
* Skin/pressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds.
* History of severe allergies, or allergies to any active or inactive ingredients of the study drug;
* Severe infections requiring intravenous antibiotic infusion or hospitalization at the time of screening; or uncontrollable active infections within 4 weeks before administration;
* Known active or suspected autoimmune diseases; or known active ocular diseases (such as active wet age-related macular degeneration, diabetic retinopathy with macular edema);
* Human immunodeficiency virus (HIV) (HIV1/2 antibody) positive, syphilis spirochete antibody positive .
* Patients with interstitial lung disease.
* History of severe cardiovascular diseases.
* Unable to orally swallow medication, or there is a condition that significantly affects gastrointestinal absorption as judged by the researcher;
* Clinical intervention is required for pleural effusion, ascites (excluding subjects who do not need drainage and have been stable for more than 2 weeks after drainage).
* Known alcohol or drug dependence.
* Mental disorders or poor compliance;
* Pregnant or lactating women;
* The investigator believes that the subject has other reasons that make them unsuitable for participating in this clinical study.

Where it's running

  • Anhui Provincial Hospital
    Hefei, Anhui, China
    Recruiting
  • Cancer Hospital Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality, China
    Recruiting
  • The First Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China
    Recruiting
  • He'nan Cancer Hospital
    Zhengzhou, Henan, China
    Recruiting
  • Shandong Cancer Hospital
    Jinan, Shandong, China
    Recruiting
  • Shanghai Chest Hospital
    Shanghai, Shanghai Municipality, China
    Recruiting
Show 6 more locations
  • Shanghai East Hospital
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Shanghai Pulmonary Hospital
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Sichuan Provincial Cancer Hospital
    Chengdu, Sichuan, China
    Recruiting
  • Tianjin Medical University Cancer Institute and Hospital
    Tianjin, Tianjin Municipality, China
    Recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
    Recruiting
  • Taizhou Hospital of Zhejiang Province
    Taizhou, Zhejiang, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.