Single Arm Study of WSD0922-FU for NSCLC Patients with C797S mutation
Key facts
- Where
- Caen Cedex 5, Limoges, Pessac, Rennes Cedex 9 és Toulon Cedex, FranciaországSee the 5 sites
- Phase
- 2. fázis
Where in Franciaország
- Centre Francois BaclesseCaen Cedex 5, FranciaországTaking people
- Centre Hospitalier Et Universitaire de LimogesLimoges, FranciaországTaking people
- Centre Hospitalier Universitaire de BordeauxPessac, FranciaországTaking people
- Centre Hospitalier Universitaire De RennesRennes Cedex 9, FranciaországTaking people
- Centre Hospitalier Intercommunal Toulon / La Seine-Sur-MerToulon Cedex, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Wayshine Biopharm Inc.
- Trial code
- EU 2024-519713-65-00
- Record updated
- 2026. június 29.
- Original description
To determine the recommended phase 2 dose [RP2D] and to assess the efficacy of WSD0922-FU by assessment of Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.Read full original descriptionShow less
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
To determine the recommended phase 2 dose [RP2D] and to assess the efficacy of WSD0922-FU by assessment of Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Inclusion: Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses; Females should be using adequate contraceptive measures; Male patients should be willing to use barrier contraception i.e., condoms; Patient must be stable on no more than 2 mg of dexamethasone; 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; Documented EGFR mutation; Patients must have confirmation of C797S mutation positive status; 8.Eastern Cooperative Oncology Group (ECOG) 0-1; At least one lesion, not previously irradiated and not chosen for biopsy during the study.
Exclusion: 1 Treatment with more than 2 prior lines of treatment for advanced NSCLC.Treatment with Osimertinib within 8 days of the first dose of study treatment; Any unresolved toxicities from prior therapy greater than CTCAE Grade 1; Leptomeningeal metastasis; 5.Any evidence of severe or uncontrolled systemic diseases; 6.Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection; History of hypersensitivity of WSD0922-FU; Known intracranial hemorrhage which is unrelated to tumor; Seizures requiring a change; Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD; 9.Inadequate bone marrow reserve or organ function as demonstrated; Any of the following cardiac criteria: Mean resting corrected QT interval (QTc) > 480 msec, obtained from electrocardiograms (ECGs); Any clinically important abnormalities in rhythm; Any factors that increase the risk of QTc prolongation; Males and females of reproductive potential who are not using an effective method of birth control; Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements; Patient must not take enzyme-inducing anticonvulsants treatment; Symptomatic brain complications that require urgent neurosurgical or medical intervention.