Non Small Cell Lung Cancer
Conditions
Keywords
C797S, BM, WSD0922-FU, NSCLC, EGFR
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.
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
DRUGWSD0922-FU Tablets, Dose level A
Oral, 21 days in each cycle
DRUGWSD0922-FU Tablets, Dose level B
Oral, 21 days in each cycle
Sponsors
Wayshine Biopharm, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | every 8 weeks, up to 1 year | proportion of patients with a best overall response of complete response or partial response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | every 8 weeks, up to 1 year | proportion of patients with the time from randomization until the date of objective disease progression or death |
| Disease Control Rate (DCR) | every 8 weeks, up to 1 year | the percentage of patients who have a best overall response of CR or PR or SD |
| Overall Survival (OS) | 24 months | the time from the date of randomization until death due to any cause |
| Duration of Response (DoR) | every 8 weeks, up to 1 year | proportion of patients with the time from the date of first documented response until the date of documented progression or death in the absence of disease progression |
| EORTC QLQ-LC13 (HRQoL) | up to 24 months | PROs will be assessed using the EORTC QLQ-LC13, changes in score compared to baseline will be evaluated. |
| PRO CTCAE (HRQoL) | up to 24 months | To be assessed using the PRO CTCAE ,changes in symptoms compared to baseline will be evaluated. |
| EORTC QLQ-C30 (HRQoL) | up to 24 months | PROs will be assessed using the EORTC QLQ-C30,changes in score compared to baseline will be evaluated. |
Countries
China, France, United States
Contacts
Primary ContactCarina Yu
Backup ContactWei Zhong
Outcome results
None listed