NCT06868485 A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer
| NCT ID | NCT06868485 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Wayshine Biopharm, Inc. |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-18 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2025-08-18 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Adjei Alex A., PhD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06868485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06868485 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06868485 currently recruiting?
Yes, NCT06868485 is actively recruiting participants. Contact the research team at ling.yu@wayshinebiopharm.com for enrollment information.
Where is the NCT06868485 trial being conducted?
This trial is being conducted at Oxnard, United States, Weston, United States, Detroit, United States, Manahawkin, United States and 11 additional locations.
Who is sponsoring the NCT06868485 clinical trial?
NCT06868485 is sponsored by Wayshine Biopharm, Inc.. The principal investigator is Adjei Alex A., PhD at The Cleveland Clinic. The trial plans to enroll 40 participants.
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