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

NCT06868485 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-08

No results posted yet for this study

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

Interventions

DRUG

WSD0922-FU Tablets, Dose level A

Oral, 21 days in each cycle

DRUG

WSD0922-FU Tablets, Dose level B

Oral, 21 days in each cycle

Sponsors & Collaborators

  • Wayshine Biopharm, Inc.

    lead INDUSTRY

Principal Investigators

  • Adjei Alex A., PhD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2027-09-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • China
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06868485 on ClinicalTrials.gov