A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer

Part of paid clinical trials in Oxnard, California.

Sponsor
Wayshine Biopharm, Inc.
Study ID
NCT06868485
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • WSD0922-FU Tablets, Dose level A — DRUG
    Oral, 21 days in each cycle
  • WSD0922-FU Tablets, Dose level B — DRUG
    Oral, 21 days in each cycle

Study Details

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.

Key Dates

Start date
Aug 18, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose level A selected from Phase I study
    BID
  • Experimental: Dose level B selected from Phase I study
    BID

Primary Outcome Measure

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

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
FOMAT OncologyOxnardCalifornia93030
Principal Investigator
[email protected]
805-483-1185
Cleveland Clinic Weston HospitalWestonFlorida33331
Principal Investigator
[email protected]
866-293-7866
Karmanos Cancer InstituteDetroitMichigan48201
Principal Investigator
[email protected]
231-487-3390
Hackensack Meridian Health-Southern Ocean Medical CenterManahawkinNew Jersey08050
Principal Investigator
[email protected]
609-597-6011
Cleveland ClinicClevelandOhio44195
Principal Investigator
[email protected]
866-320-4573
UPMC Hillman Cancer CenterPittsburghPennsylvania15235
Principal Investigator
[email protected]
412-755-3069
TxO Central/South, Texas Oncology -Central/South TexasAustinTexas78745
Principal Investigator
[email protected]
888-864-4226
Virginia Cancer SpecialistsFairfaxVirginia22031
Principal Investigator
[email protected]
703-636-1473

Find similar trials in Oxnard, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
FOMAT Oncology· Oxnard, CACleveland Clinic Weston Hospital· Weston, FLKarmanos Cancer Institute· Detroit, MIHackensack Meridian Health-Southern Ocean Medical Center· Manahawkin, NJCleveland Clinic· Cleveland, OHUPMC Hillman Cancer Center· Pittsburgh, PA

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