Non Small Cell Lung CancerPhase 2NCT06868485
A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer
A Phase 2 study testing WSD0922-FU Tablets, Dose level A and WSD0922-FU Tablets, Dose level B in people with Non Small Cell Lung Cancer, run by Wayshine Biopharm, Inc. at 18 sites in 3 countries.
Trial summary
This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- WSD0922-FU Tablets, Dose level A and WSD0922-FU Tablets, Dose level B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 18 Aug 2025to 31 Dec 2027
- Phase
- Phase 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
- Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
- Male or female aged ≥18 years old.
- Histological or cytological confirmation diagnosis of NSCLC.
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
- Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment.
- Documented EGFR mutation .
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- Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12 weeks.
- At least one lesion, not previously irradiated and not chosen for biopsy during the study.
- Females should have evidence of non-childbearing potential.
Who cannot join
- Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.
- Symptomatic brain complications that require urgent neurosurgical or medical intervention.
- Any evidence of severe or uncontrolled systemic diseases.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
- Past medical history of ILD.
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- Inadequate bone marrow reserve or organ function as demonstrated.
- Males and females of reproductive potential.
- Known intracranial hemorrhage which is unrelated to tumor.
- Seizures requiring a change in anti-epileptic medications.
Trial locations and contacts
18 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 3 countries
United States8 sites, 8 recruiting
- Recruiting
TxO Central/South, Texas Oncology -Central/South Texas
Austin, Texas, 78745
Principal Investigator, 888-864-4226, james.uyeki@usoncology.com
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Principal Investigator, 866-320-4573, ADJEIA2@ccf.org
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Principal Investigator, 231-487-3390, upretyd@karmanos.org
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Principal Investigator, 703-636-1473, Alexander.Spira@USOncology.com
- Recruiting
Hackensack Meridian Health-Southern Ocean Medical Center
Manahawkin, New Jersey, 08050
Principal Investigator, 609-597-6011, Jatin.desani@hmhn.org
- Recruiting
FOMAT Oncology
Oxnard, California, 93030
Principal Investigator, 805-483-1185, nkhan@fomatmedical.com
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15235
Principal Investigator, 412-755-3069, villaruzl@upmc.edu
- Recruiting
Cleveland Clinic Weston Hospital
Weston, Florida, 33331
Principal Investigator, 866-293-7866, saravid@ccf.org
China5 sites, 5 recruiting
- Recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014
Principal Investigator, 86-0591-83660063, 1609305255@qq.com
- Recruiting
Shanghai East hospital
Shanghai, Shanghai Municipality, 200120
Principal Investigator, 86-21-38804518, caicunzhoudr@tongji.edu.cn
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Principal Investigator, 86-21-65115006, fywu@163.com
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300202
Principal Investigator, 86-022-23353454, dingzhih72@163.com
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430022
Principal Investigator, 86-27-85726300, xhzzdxr@126.com
France5 sites, 5 recruiting
- Recruiting
Centre Francois Baclesse
Caen, Normandy, 14000
Principal Investigator, 33-231455050, h.curcio@baclesse.unicancer.fr
- Recruiting
Centre Hospitalier Universitaire CHU De Limoges
Limoges, New Aquitaine, 87042
Principal Investigator, 33-555055555, Thomas.Egenod@chu-limoges.fr
- Recruiting
CHU Bordeaux - Centre Francois Magendie
Pessac, New Aquitaine, 33604
Principal Investigator, 33-557656338, remi.veillon@chu-bordeaux.fr
- Recruiting
Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou
Rennes, Ille-et-Vilaine, 35000
Principal Investigator, 33-299-284321, herve.lena@chu-rennes.fr
- Recruiting
CHU Toulon - Hopital Sainte Musse
Toulon, Var, 83100
Principal Investigator, 33-494145000, clarisse.audigier-valette@ch-toulon.fr
About this study
Official title: A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation
This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.
Read the detailed description
WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ (TKI sensitivity conferring mutation) and dual EGFRm+/C797S+ (third-generation TKI as first-line resistance conferring mutation) receptor forms of EGFR with selectivity margin over wild-type EGFR. Therefore WSD0922-FU has the potential to provide clinical benefit to patients with advanced NSCLC harboring both the single sensitivity mutations and the resistance mutation following first-line therapy with a third-generation EGFR TKI (e.g., Osimertinib). The clinical development program with WSD0922-FU will assess the safety and efficacy of WSD0922-FU in patients with advanced NSCLC whose cancers have progressed with or without brain metastasis following a first-line Osimertinib treatment.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- WSD0922-FU Tablets, Dose level A, WSD0922-FU Tablets, Dose level B
- Keywords
- C797S, BM, WSD0922-FU, NSCLC, EGFR
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WSD0922-FU Tablets, Dose level ADrug
Also called WSD0922
Oral, 21 days in each cycle
WSD0922-FU Tablets, Dose level BDrug
Also called WSD0922
Oral, 21 days in each cycle
| Study group | Role | What they receive |
|---|---|---|
| Dose level A selected from Phase I study | Experimental | BID Receives: Drug: WSD0922-FU Tablets, Dose level A |
| Dose level B selected from Phase I study | Experimental | BID Receives: Drug: WSD0922-FU Tablets, Dose level B |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
proportion of patients with a best overall response of complete response or partial response
Measured: every 8 weeks, up to 1 year
Secondary outcomes (7)
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 8 weeks, up to 1 year
PFS
proportion of patients with the time from randomization until the date of objective disease progression or death
Measured: every 8 weeks, up to 1 year
Disease Control Rate (DCR)
the percentage of patients who have a best overall response of CR or PR or SD
Measured: every 8 weeks, up to 1 year
Overall Survival (OS)
the time from the date of randomization until death due to any cause
Measured: 24 months
EORTC QLQ-C30 (HRQoL)
PROs will be assessed using the EORTC QLQ-C30,changes in score compared to baseline will be evaluated.
Measured: up to 24 months
EORTC QLQ-LC13 (HRQoL)
PROs will be assessed using the EORTC QLQ-LC13, changes in score compared to baseline will be evaluated.
Measured: up to 24 months
PRO CTCAE (HRQoL)
To be assessed using the PRO CTCAE ,changes in symptoms compared to baseline will be evaluated.
Measured: 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 posted11 Mar 2025
- Study start18 Aug 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (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 CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayshine Biopharm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adjei Alex A., PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868485
- Sponsor's protocol ID
- WS2202
- Status last verified
- Aug 2025
- First submitted
- 22 Feb 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation
- ClinicalTrials.gov ID
- NCT06868485
- Acronym / sponsor ID
- WS2202
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- C797S, BM, WSD0922-FU, NSCLC, EGFR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wayshine Biopharm, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Mar 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 II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.
Detailed description
WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ (TKI sensitivity conferring mutation) and dual EGFRm+/C797S+ (third-generation TKI as first-line resistance conferring mutation) receptor forms of EGFR with selectivity margin over wild-type EGFR. Therefore WSD0922-FU has the potential to provide clinical benefit to patients with advanced NSCLC harboring both the single sensitivity mutations and the resistance mutation following first-line therapy with a third-generation EGFR TKI (e.g., Osimertinib). The clinical development program with WSD0922-FU will assess the safety and efficacy of WSD0922-FU in patients with advanced NSCLC whose cancers have progressed with or without brain metastasis following a first-line Osimertinib treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose level A selected from Phase I study | Experimental | Drug: WSD0922-FU Tablets, Dose level ABID |
| Dose level B selected from Phase I study | Experimental | Drug: WSD0922-FU Tablets, Dose level BBID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
- Male or female aged ≥18 years old.
- Histological or cytological confirmation diagnosis of NSCLC.
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
- Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment.
Key exclusion criteria (10 listed)
- Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.
- Symptomatic brain complications that require urgent neurosurgical or medical intervention.
- Any evidence of severe or uncontrolled systemic diseases.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
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 |
|---|---|---|
| WSD0922-FU Tablets, Dose level AAlso: WSD0922Oral, 21 days in each cycle | Drug | Dose level A selected from Phase I study |
| WSD0922-FU Tablets, Dose level BAlso: WSD0922Oral, 21 days in each cycle | Drug | Dose level B selected from Phase I study |
Primary outcome
ORR
Time frame: every 8 weeks, up to 1 year
proportion of patients with a best overall response of complete response or partial response
7 secondary outcomes
Duration of Response (DoR)
Time frame: every 8 weeks, up to 1 year
PFS
Time frame: every 8 weeks, up to 1 year
Disease Control Rate (DCR)
Time frame: every 8 weeks, up to 1 year
Overall Survival (OS)
Time frame: 24 months
EORTC QLQ-C30 (HRQoL)
Time frame: up to 24 months
EORTC QLQ-LC13 (HRQoL)
Time frame: up to 24 months
PRO CTCAE (HRQoL)
Time frame: 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 8 Sep 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.
Adjei Alex A., PhD principal investigator
The Cleveland Clinic
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WSD0922-FU Tablets, Dose level A and WSD0922-FU Tablets, Dose level B in people with Non Small Cell Lung Cancer, run by Wayshine Biopharm, Inc. at 18 sites in 3 countries.
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 9 inclusion and 10 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, China, France. 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 phase mean?
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 Carina Yu (951-547-4692, ling.yu@wayshinebiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: every 8 weeks, up to 1 year). 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 8 Sep 2025.