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

Recruiting now · Phase 2

Conditions studied: Non Small Cell Lung Cancer

In brief

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 facts

Study ID

NCT06868485

Run by

Wayshine Biopharm, Inc.

People needed

40

Starts

2025-08-18

Expected to finish

2027-12-31

Last updated by the study team

2025-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• FOMAT Oncology — Oxnard, California, United States (enrolling)
• Cleveland Clinic Weston Hospital — Weston, Florida, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• Hackensack Meridian Health-Southern Ocean Medical Center — Manahawkin, New Jersey, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• TxO Central/South, Texas Oncology -Central/South Texas — Austin, Texas, United States (enrolling)
• Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
• Fujian Provincial Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Wuhan Union Hospital — Wuhan, Hubei, China (enrolling)
• Shanghai East hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou — Rennes, Ille-et-Vilaine, France (enrolling)
• Centre Hospitalier Universitaire CHU De Limoges — Limoges, New Aquitaine, France (enrolling)
• CHU Bordeaux - Centre Francois Magendie — Pessac, New Aquitaine, France (enrolling)
• Centre Francois Baclesse — Caen, Normandy, France (enrolling)
• CHU Toulon - Hopital Sainte Musse — Toulon, Var, France (enrolling)

Full record on ClinicalTrials.gov

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