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Tests treatment safety and results for Non Small Cell Lung Cancer
Official title A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06868485
What this study is testing
What is WSD0922-FU Tablets, Dose level A?
WSD0922-FU Tablets, Dose level A is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non small cell lung cancer.
Also referred to as WSD0922.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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...
- 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...
- Past medical history of ILD.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Oxnard, California, United States
- Weston, Florida, United States
- Detroit, Michigan, United States
- Manahawkin, New Jersey, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Austin, Texas, United States
- Fairfax, Virginia, United States
- Fuzhou, Fujian, China
- Wuhan, Hubei, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin Municipality, China
- Rennes, Ille-et-Vilaine, France
- Limoges, New Aquitaine, France
- Pessac, New Aquitaine, France
- Caen, Normandy, France
- Toulon, Var, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oxnard, California, United States; Weston, Florida, United States; Detroit, Michigan, United States; Manahawkin, New Jersey, United States; Cleveland, Ohio, United States; Pittsburgh, Pennsylvania, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.