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Study of WSD0922-FU for Patients with Advanced Non-Small Cell Lung Cancer and C797S Mutation After Osimertinib Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed after first-line treatment with osimertinib. The study specifically focuses on patients whose tumors have a C797S mutation in the epidermal growth factor receptor (EGFR) gene. This mutation is a specific change in the genetic material of cancer cells that affects how they respond to treatment.

The purpose of this study is to evaluate an investigational drug called WSD0922-FU in these patients. This is a Phase II study, which means it aims to further assess the safety of the drug and to determine how effective it is in treating this specific type of lung cancer.

During the study, all participants will receive the investigational drug WSD0922-FU. Doctors will monitor how patients' tumors respond to the treatment through regular medical evaluations and imaging tests. The study will measure how many patients experience tumor shrinkage, how long patients live without their cancer worsening, and how long any positive responses to the treatment last.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Consent

    You will provide signed and dated written informed consent before any study procedures begin.

    Your eligibility will be confirmed, including verification that you are at least 18 years old with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for curative surgery or radiation therapy.

    Your tumor must have a confirmed C797S mutation in the EGFR gene (Epidermal Growth Factor Receptor) and show evidence of disease progression.

  2. Step 2

    Baseline Assessments

    Your current health status will be evaluated, including confirmation that you have an ECOG performance status of 0-1 (able to perform daily activities with minimal or no limitations).

    Your tumor will be assessed to confirm at least one measurable lesion that has not been previously treated with radiation and will not be selected for biopsy during the study.

    If you are taking dexamethasone, it must be at a stable dose of no more than 2 mg.

  3. Step 3

    Treatment with WSD0922-FU

    You will begin taking WSD0922-FU tablets. This medication is also known as (r)-6-((3,3-difluoro-1-methylpiperidin-4-yl)oxy)-n-(3-ethynyl-2-fluorophenyl)-7-methoxyquinazolin-4-amine-fumarate.

    The exact dosage and frequency will be determined during the study, as one of the main goals is to establish the recommended Phase 2 dose (RP2D).

    Throughout the treatment period, you must follow contraception requirements: females should use adequate contraceptive measures, and males should use barrier contraception (condoms).

  4. Step 4

    Regular Monitoring and Assessments

    Your tumor response will be regularly evaluated using RECIST v1.1 (Response Evaluation Criteria in Solid Tumors), which is a standard method to measure how tumors respond to treatment.

    These assessments will track any changes in tumor size and monitor for disease progression or response to the medication.

    The main measurement being tracked is Objective Response Rate (ORR), which indicates if your tumor is shrinking in response to treatment.

  5. Step 5

    Additional Outcome Measurements

    Throughout the study, several other outcomes will be measured:

    Progression Free Survival (PFS): how long until your disease worsens

    Duration of Response (DoR): how long your tumor response lasts

    Disease Control Rate (DCR): the percentage of patients whose disease stabilizes or improves

    Change in Tumor Size: specific measurements of tumor dimensions

    Overall Survival (OS): how long patients live after starting treatment

  6. Step 6

    Study Completion

    The study is scheduled to run until May 30, 2025, with final data collection for the primary outcome measure.

    The entire study, including all follow-up periods, is expected to conclude by June 30, 2027.

    Your participation in the study may end earlier if your disease progresses, if you experience unacceptable side effects, or if you choose to withdraw.

Who can join the trial?

12 criteria

  • You must provide signed and dated written consent before any study procedures or tests are done.
  • You must be at least 18 years old (male or female).
  • You must have confirmed non-small cell lung cancer (NSCLC) through tissue or cell examination.
  • Your cancer must be locally advanced or metastatic (has spread), and not treatable with surgery or radiation therapy.
  • You must show evidence that your cancer is growing or getting worse on scans.
  • You must have a documented EGFR mutation (a specific genetic change in your cancer).
  • You must have confirmation of a C797S mutation (another specific genetic change).
  • Your performance status must be ECOG 0-1 (you must be able to care for yourself and be up and about more than 50% of waking hours).
  • You must have at least one tumor lesion that has not been previously treated with radiation and will not be chosen for biopsy during the study.
  • If you are female, you must be using adequate birth control methods.
  • If you are male, you must be willing to use condoms.
  • If you are taking dexamethasone (a steroid medication), the dose must be stable and not more than 2 mg.

Who cannot join the trial?

15 criteria

  • You have small cell lung cancer (a specific type of lung cancer that is not being studied in this trial).
  • You have cancer that has spread to the brain or spinal cord, unless your brain tumors have been treated, are stable, and you no longer need steroids for at least 14 days.
  • You have had surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy within 28 days before starting the study.
  • You have had treatment with any investigational drug (drugs being tested in research) within 28 days before starting the study.
  • You have any heart problems including heart attack within the last 6 months, heart failure, abnormal heart rhythm, or conditions that could lead to these problems.
  • You have high blood pressure that is not controlled with medication.
  • You have had a stroke or mini-stroke within the last 6 months.
  • You have significant bleeding problems or are at risk for bleeding.
  • You are taking blood-thinning medications (except for low-dose aspirin).
  • You have problems with your digestive system that might affect how the study drug is absorbed.
  • You have a serious infection requiring treatment.
  • You have HIV, Hepatitis B, or active Hepatitis C infection.
  • You are pregnant or breastfeeding.
  • You cannot use effective birth control during the study and for 3 months after the last dose of study drug.
  • You have any other medical condition that the study doctor thinks would make it unsafe for you to participate.
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Investigated drugs

WSD0922-FU is a medication being studied for patients with advanced non-small cell lung cancer. It's specifically designed for patients whose cancer has progressed after treatment with osimertinib and whose tumors have a specific genetic mutation called C797S in the EGFR gene. This medication is being tested to see how well it works in shrinking tumors or stopping them from growing.

What is already known about the treatment

WSD0922-FU – An investigational medication being studied for locally advanced or metastatic non-small cell lung cancer in patients whose disease has progressed after first-line osimertinib treatment and whose tumors have a specific C797S mutation in the EGFR gene. This drug is currently in Phase II clinical trials, indicating it has shown initial safety but is still being evaluated for efficacy. While the exact mechanism is not fully detailed in the provided information, it likely targets the specific EGFR mutation that confers resistance to earlier treatments. WSD0922-FU belongs to the class of targeted cancer therapies and is being assessed primarily for its ability to shrink tumors in patients with this specific genetic profile.

Investigated diseases

Non-Small Cell Lung Cancer – A type of lung cancer that encompasses several subtypes including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It begins when abnormal cells in the lung grow uncontrollably, forming a tumor that may invade nearby tissues and spread to other parts of the body. The disease typically progresses slowly compared to small cell lung cancer, often starting with no symptoms but eventually leading to persistent cough, chest pain, shortness of breath, hoarseness, and weight loss. As the cancer advances, it can spread (metastasize) to lymph nodes and distant organs including the brain, bones, liver, and adrenal glands. The progression rate varies considerably depending on the specific subtype, stage at diagnosis, and individual patient factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519713-65-00Protocol codeWS2202Estimated enrolment40 patientsSponsorWayshine Biopharm Inc.

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