Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WSD0922-FU Tablets, Dose level A | Drug | — | UNRESOLVED |
| WSD0922-FU Tablets, Dose level B | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose level A selected from Phase I study
- description
- BID
- interventionNames
- Drug: WSD0922-FU Tablets, Dose level A
- type
- EXPERIMENTAL
- label
- Dose level B selected from Phase I study
- description
- BID
- interventionNames
- Drug: WSD0922-FU Tablets, Dose level B
Primary outcomes (1)
- measure
- ORR
- timeFrame
- every 8 weeks, up to 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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. Exclusion criteria: * 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.
References
Publications (0)
Data not yet available