RECRUITING

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

Description

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
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Related Conditions:

Non Small Cell Lung Cancer

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Non Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Oxnard

FOMAT Oncology, Oxnard, California, United States, 93030

Weston

Cleveland Clinic Weston Hospital, Weston, Florida, United States, 33331

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Manahawkin

Hackensack Meridian Health-Southern Ocean Medical Center, Manahawkin, New Jersey, United States, 08050

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Pittsburgh

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States, 15235

Austin

TxO Central/South, Texas Oncology -Central/South Texas, Austin, Texas, United States, 78745

Fairfax

Virginia Cancer Specialists, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wayshine Biopharm, Inc.,

Adjei Alex A., PhD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2027-12-31