A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer
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
1 other identifier
interventional
40
3 countries
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2025
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2025
CompletedFirst Posted
Study publicly available on registry
March 11, 2025
CompletedStudy Start
First participant enrolled
August 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
September 8, 2025
August 1, 2025
2.1 years
February 22, 2025
August 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ORR
proportion of patients with a best overall response of complete response or partial response
every 8 weeks, up to 1 year
Secondary Outcomes (7)
Duration of Response (DoR)
every 8 weeks, up to 1 year
PFS
every 8 weeks, up to 1 year
Disease Control Rate (DCR)
every 8 weeks, up to 1 year
Overall Survival (OS)
24 months
EORTC QLQ-C30 (HRQoL)
up to 24 months
- +2 more secondary outcomes
Study Arms (2)
Dose level A selected from Phase I study
EXPERIMENTALBID
Dose level B selected from Phase I study
EXPERIMENTALBID
Interventions
Oral, 21 days in each cycle
Oral, 21 days in each cycle
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
FOMAT Oncology
Oxnard, California, 93030, United States
Cleveland Clinic Weston Hospital
Weston, Florida, 33331, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Hackensack Meridian Health-Southern Ocean Medical Center
Manahawkin, New Jersey, 08050, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15235, United States
TxO Central/South, Texas Oncology -Central/South Texas
Austin, Texas, 78745, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014, China
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Shanghai East hospital
Shanghai, Shanghai Municipality, 200120, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300202, China
Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou
Rennes, Ille-et-Vilaine, 35000, France
Centre Francois Baclesse
Caen, Normandy, 14000, France
Centre Hospitalier Universitaire CHU De Limoges
Limoges, Nouvelle-Aquitaine, 87042, France
CHU Bordeaux - Centre Francois Magendie
Pessac, Nouvelle-Aquitaine, 33604, France
CHU Toulon - Hopital Sainte Musse
Toulon, Var, 83100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adjei Alex A., PhD
The Cleveland Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2025
First Posted
March 11, 2025
Study Start
August 18, 2025
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
September 8, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share