Non Small Cell Lung Cancer (NSCLC)Phase 1/2WAYWIN103NCT07206498
A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC
A Phase 1/2 study testing Osimertinib (Tagrisso®) and WSD0922-FU in people with Non Small Cell Lung Cancer (NSCLC), run by Wayshine Biopharm, Inc. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Osimertinib (Tagrisso®) and WSD0922-FU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2025to 14 Oct 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, 200123
Fei Zhou, MD, +86 21-38804518, fei.zhou@tongji.edu.cn
Caicun Zhou, MD
About this study
Official title: A Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU in Combination With Osimertinib for Patients With Locally Advanced or Metastatic Non- Small Cell Lung Cancer
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
Read the detailed description
WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ and dual EGFRm+/C797S+ receptor forms of EGFR with selectivity margin over wild-type EGFR. This study aims to explore the safety, tolerability, pharmacokinetic characteristics and efficacy of WSD0922-FU combined with Osimertinib in patients with non-small cell lung cancer (NSCLC) with C797S mutation after first-line third-generation EGFR-TKI resistance, and then further confirm the safety and efficacy for newly diagnosed NSCLC BM patients with classical EGFR Del19 or L858R mutation
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Being tested
- Osimertinib (Tagrisso®), WSD0922-FU
- Keywords
- WSD0922, WSD0922-FU, NSCLC, CNS metastasis, Brain metastasis, EGFR, C797S, Del19, L858R
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
WSD0922-FUDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Osimertinib (Tagrisso®); Drug: WSD0922-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
PartA: To evaluate the safety of WSD0922-FU combined with Osimertinib in patients with NSCLC
Safety (incidence and severity of adverse events [AE])
Measured: 12 months
PartB: To evaluate the efficacy of WSD0922-FU combined with Osimertinib in patients with NSCLC
ORR
Measured: 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
Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs)
Measured: 12 months
Disease Control Rate (DCR)
the percentage of patients who have a best overall response of CR or PR or SD
Measured: every 6 weeks, up to 24 months
Duration of Response (DoR)
proportion of patients with the time from the date of first documented response until the date of documented progression or death in the absence of disease progression
Measured: every 6 weeks, up to 24 months
PFS
proportion of patients with the time from randomization until the date of objective disease progression or death
Measured: every 6 weeks, up to 24 months
Intracranial Disease Control Rate (iDCR)
the percentage of patients who have a best overall response of CR or PR or SD per RANO BM
Measured: every 6 weeks, up to24 months
Intracranial Duration of Response (iDoR)
proportion of patients with the time from the date of first documented response until the date of documented progression or death in the absence of disease progression per RANO BM
Measured: every 6 weeks, up to 24 months
iPFS
proportion of patients with the time from randomization until the date of objective disease progression or death per RANO BM
Measured: every 6 weeks, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start17 Oct 2025
- Primary completion14 Oct 2028 (estimated)
- Study completion14 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part A (Dose escalation study) ; Part B (Does expansion study).
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayshine Biopharm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206498
- Sponsor's protocol ID
- WSD0922-103
- Acronym
- WAYWIN103
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU in Combination With Osimertinib for Patients With Locally Advanced or Metastatic Non- Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07206498
- Acronym / sponsor ID
- WAYWIN103 / WSD0922-103
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Keywords
- WSD0922, WSD0922-FU, NSCLC, CNS metastasis, Brain metastasis, EGFR, C797S, Del19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Wayshine Biopharm, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 14 Oct 2028 (estimated)
- Study completion
- 14 Oct 2029 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ and dual EGFRm+/C797S+ receptor forms of EGFR with selectivity margin over wild-type EGFR. This study aims to explore the safety, tolerability, pharmacokinetic characteristics and efficacy of WSD0922-FU combined with Osimertinib in patients with non-small cell lung cancer (NSCLC) with C797S mutation after first-line third-generation EGFR-TKI resistance, and then further confirm the safety and efficacy for newly diagnosed NSCLC BM patients with classical EGFR Del19 or L858R mutation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part A (Dose escalation study) ; Part B (Does expansion study).
| Arm | Type | Receives |
|---|---|---|
| Dose escalation (WSD0922-FU and Osimertinib) | Experimental | Drug: Osimertinib (Tagrisso®), Drug: WSD0922-FUPatients 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. |
| Dose expansion (WSD0922-FU and Osimertinib) | Experimental | Drug: Osimertinib (Tagrisso®), Drug: WSD0922-FUPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥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;
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osimertinib (Tagrisso®)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 | Drug | Dose escalation (WSD0922-FU and Osimertinib), Dose expansion (WSD0922-FU and Osimertinib) |
| WSD0922-FUDrug: 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 | Drug | Dose escalation (WSD0922-FU and Osimertinib), Dose expansion (WSD0922-FU and Osimertinib) |
Primary outcome
PartA: To evaluate the safety of WSD0922-FU combined with Osimertinib in patients with NSCLC
Time frame: 12 months
Safety (incidence and severity of adverse events [AE])
PartB: To evaluate the efficacy of WSD0922-FU combined with Osimertinib in patients with NSCLC
Time frame: every 6 weeks, up to 2 years
ORR
7 secondary outcomes
To evaluate the safety of WSD0922-FU in patients with advanced non-small cell lung cancer
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: every 6 weeks, up to 24 months
Duration of Response (DoR)
Time frame: every 6 weeks, up to 24 months
PFS
Time frame: every 6 weeks, up to 24 months
Intracranial Disease Control Rate (iDCR)
Time frame: every 6 weeks, up to24 months
Intracranial Duration of Response (iDoR)
Time frame: every 6 weeks, up to 24 months
iPFS
Time frame: every 6 weeks, up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Osimertinib (Tagrisso®) and WSD0922-FU in people with Non Small Cell Lung Cancer (NSCLC), run by Wayshine Biopharm, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lily Liu, MD (+8613818880308, lily.liu@wayshinebiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PartA: To evaluate the safety of WSD0922-FU combined with Osimertinib in patients with NSCLC (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.