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Study identifier: NCT06868485 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Recruiting

A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer

Condition: Non Small Cell Lung Cancer  ·  Sponsor: Wayshine Biopharm, Inc.

PhasePhase 2
Planned participants40
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where18 locations · 3 countries

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Carina Yu  ·  951-547-4692  ·  ling.yu@wayshinebiopharm.com

Wei Zhong  ·  951-547-4692  ·  wei.zhong@wayshinebiopharm.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (18)

FOMAT OncologyOxnard, California, United StatesRecruiting
Cleveland Clinic Weston HospitalWeston, Florida, United StatesRecruiting
Karmanos Cancer InstituteDetroit, Michigan, United StatesRecruiting
Hackensack Meridian Health-Southern Ocean Medical CenterManahawkin, New Jersey, United StatesRecruiting
Cleveland ClinicCleveland, Ohio, United StatesRecruiting
UPMC Hillman Cancer CenterPittsburgh, Pennsylvania, United StatesRecruiting
TxO Central/South, Texas Oncology -Central/South TexasAustin, Texas, United StatesRecruiting
Virginia Cancer SpecialistsFairfax, Virginia, United StatesRecruiting
Fujian Provincial Cancer HospitalFuzhou, Fujian, ChinaRecruiting
Wuhan Union HospitalWuhan, Hubei, ChinaRecruiting
Shanghai East hospitalShanghai, Shanghai Municipality, ChinaRecruiting
Shanghai Pulmonary HospitalShanghai, Shanghai Municipality, ChinaRecruiting

+ 6 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

OxnardWestonDetroitManahawkin

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