Recruiting
Phase 2

WSD0922-FU

Sponsor:

Wayshine Biopharm, Inc.

Code:

NCT06868485

Conditions

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

WSD0922-FU Tablets, Dose level A

WSD0922-FU Tablets, Dose level B

Study Details

Brief 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.

Conditions

Non Small Cell Lung Cancer

Study ID

NCT06868485

Start date

Aug 18, 2025

Status verified date

Aug, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • 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 .
  • 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.

Exclusion criteria:

  • 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.
  • 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose level A selected from Phase I study

BID

experimental: Dose level B selected from Phase I study

BID

Interventions

WSD0922-FU Tablets, Dose level A

Oral, 21 days in each cycle

WSD0922-FU Tablets, Dose level B

Oral, 21 days in each cycle

Primary outcome measure

  • ORR [ Time Frame: every 8 weeks, up to 1 year ]

Central Contacts and Locations

Central contacts

Carina Yu

951-547-4692ling.yu@wayshinebiopharm.com

Wei Zhong

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

Locations

FOMAT Oncology

Recruiting

Oxnard, California, United States, 93030

Contacts

Principal Investigator

805-483-1185nkhan@fomatmedical.com

Cleveland Clinic Weston Hospital

Recruiting

Weston, Florida, United States, 33331

Contacts

Principal Investigator

866-293-7866saravid@ccf.org

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Principal Investigator

231-487-3390upretyd@karmanos.org

Hackensack Meridian Health-Southern Ocean Medical Center

Recruiting

Manahawkin, New Jersey, United States, 08050

Contacts

Principal Investigator

609-597-6011Jatin.desani@hmhn.org

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator

866-320-4573ADJEIA2@ccf.org

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15235

Contacts

Principal Investigator

412-755-3069villaruzl@upmc.edu

TxO Central/South, Texas Oncology -Central/South Texas

Recruiting

Austin, Texas, United States, 78745

Contacts

Principal Investigator

888-864-4226james.uyeki@usoncology.com

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Principal Investigator

703-636-1473Alexander.Spira@USOncology.com

More Information

Sponsor

Wayshine Biopharm, Inc.

Last update posted

Sep 8, 2025

Last verified

Aug, 2025

Keywords

  • C797S
  • BM
  • WSD0922-FU
  • NSCLC
  • EGFR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wayshine Biopharm, Inc. on 2025-09-08.