A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WSD0922-FU Tablets, Dose level A, WSD0922-FU Tablets, Dose level B.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China, France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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.
Detailed description
WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ (TKI sensitivity conferring mutation) and dual EGFRm+/C797S+ (third-generation TKI as first-line resistance conferring mutation) receptor forms of EGFR with selectivity margin over wild-type EGFR. Therefore WSD0922-FU has the potential to provide clinical benefit to patients with advanced NSCLC harboring both the single sensitivity mutations and the resistance mutation following first-line therapy with a third-generation EGFR TKI (e.g., Osimertinib). The clinical development program with WSD0922-FU will assess the safety and efficacy of WSD0922-FU in patients with advanced NSCLC whose cancers have progressed with or without brain metastasis following a first-line Osimertinib treatment.
Interventions
- Drug WSD0922-FU Tablets, Dose level A
Oral, 21 days in each cycle - Drug WSD0922-FU Tablets, Dose level B
Oral, 21 days in each cycle
Primary outcome measures
- ORR [Time frame: every 8 weeks, up to 1 year]
Secondary outcome measures (7)
- Duration of Response (DoR) [Time frame: every 8 weeks, up to 1 year]
- PFS [Time frame: every 8 weeks, up to 1 year]
- Disease Control Rate (DCR) [Time frame: every 8 weeks, up to 1 year]
- Overall Survival (OS) [Time frame: 24 months]
- EORTC QLQ-C30 (HRQoL) [Time frame: up to 24 months]
- EORTC QLQ-LC13 (HRQoL) [Time frame: up to 24 months]
- PRO CTCAE (HRQoL) [Time frame: up to 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- FOMAT Oncology — Oxnard
- Cleveland Clinic Weston Hospital — Weston
- Karmanos Cancer Institute — Detroit
- Hackensack Meridian Health-Southern Ocean Medical Center — Manahawkin
- Cleveland Clinic — Cleveland
- UPMC Hillman Cancer Center — Pittsburgh
- TxO Central/South, Texas Oncology -Central/South Texas — Austin
- Virginia Cancer Specialists — Fairfax
China · 5 centers
- Fujian Provincial Cancer Hospital — Fuzhou
- Wuhan Union Hospital — Wuhan
- Shanghai East hospital — Shanghai
- Shanghai Pulmonary Hospital — Shanghai
- Tianjin Medical University Cancer Institute and Hospital — Tianjin
France · 5 centers
- Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou — Rennes
- Centre Hospitalier Universitaire CHU De Limoges — Limoges
- CHU Bordeaux - Centre Francois Magendie — Pessac
- Centre Francois Baclesse — Caen
- CHU Toulon - Hopital Sainte Musse — Toulon
Identifiers
NCT: NCT06868485 · WS2202