A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC

NCT07206498 | Recruiting Phase 1

• 1 other identifier: WSD0922-103
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I/II, Open Label Study of WSD0922-FU in Combination with Osimertinib for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose disease has progressed with third-generation EGFR-TKI with C797S mutation or is newly diagnosed with CNS metastasis with EGFR Del19 or L858R mutation

Conditions

Non Small Cell Lung Cancer (NSCLC)

Keywords

WSD0922; WSD0922-FU; NSCLC; CNS metastasis; Brain metastasis; EGFR; C797S; Del19; L858R

Outcome Measures

Primary Outcomes (2)

• PartA: To evaluate the safety of WSD0922-FU combined with Osimertinib in patients with NSCLC

  Safety (incidence and severity of adverse events \[AE\])

  12 months

• PartB: To evaluate the efficacy of WSD0922-FU combined with Osimertinib in patients with NSCLC

  ORR

  every 6 weeks, up to 2 years

Secondary Outcomes (7)

• To evaluate the safety of WSD0922-FU in patients with advanced non-small cell lung cancer

  12 months

• Disease Control Rate (DCR)

  every 6 weeks, up to 24 months

• Duration of Response (DoR)

  every 6 weeks, up to 24 months

• PFS

  every 6 weeks, up to 24 months

• Intracranial Disease Control Rate (iDCR)

  every 6 weeks, up to24 months

Study Arms (2)

Dose escalation (WSD0922-FU and Osimertinib)

EXPERIMENTAL

Patients receive 80mg Osimertinib PO QD and WSD0922-FU PO QD. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study.

Drug: Osimertinib (Tagrisso®); Drug: WSD0922-FU

Dose expansion (WSD0922-FU and Osimertinib)

EXPERIMENTAL

Patients receive 80mg Osimertinib PO QD and WSD0922-FU PO QD using dosage selected from Dose escalation. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study.

Drug: Osimertinib (Tagrisso®); Drug: WSD0922-FU

Interventions

Osimertinib (Tagrisso®) DRUG

Drug: Osimertinib Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI Drug: Osimertinib Given PO, 80mg, once daily

Dose escalation (WSD0922-FU and Osimertinib); Dose expansion (WSD0922-FU and Osimertinib)

WSD0922-FU DRUG

Drug: WSD0922-FU Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI Drug: WSD0922-FU Given PO

Dose escalation (WSD0922-FU and Osimertinib); Dose expansion (WSD0922-FU and Osimertinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥Age 18, gender is not limited;
• Locally advanced or metastatic NSCLC confirmed by pathology;
• Patients who have been genetically tested to carry EGFR sensitive mutations;
• Blood/Tissue samples must be provided for testing;
• 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.

You may not qualify if:

• 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 two EGFR-TKI inhibitors for part A;
• 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 drugs.
• 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;

Sponsors & Collaborators

• Wayshine Biopharm, Inc.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, 200123, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

lily Liu, MD

CONTACT

+8613818880308; lily.liu@wayshinebiopharm.com

Wei Zhong, PhD

CONTACT

1-951-547-4692; wei.zhong@wayshinebiopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A (Dose escalation study) ; Part B (Does expansion study).

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 3, 2025
• Study Start: October 17, 2025
• Primary Completion (Estimated): October 14, 2028
• Study Completion (Estimated): October 14, 2029
• Last Updated: November 28, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)