Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing WSD0922-FU Tablets, Dose level A for Non Small Cell Lung Cancer

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.

Official registry: https://clinicaltrials.gov/study/NCT06868485 · Wayshine Biopharm, Inc. · enrollment listed as 40

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are WSD0922-FU Tablets, Dose level A, or WSD0922-FU Tablets, Dose level B. The registry lists allocation as randomized. 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.

They plan to enroll about 40 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: WSD0922-FU Tablets, Dose level A, WSD0922-FU Tablets, Dose level B

Primary outcome (registry wording): ORR

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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

Public study contact (from the registry)

Lily Liu

951-547-4692

lily.liu@wayshinebiopharm.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

16 listed

+ 10 sites outside the US on the same record

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NCT00001823 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

FAQ about this NCT record

Is NCT06868485 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06868485?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06868485?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary