RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Osimertinib (Tagrisso®) for Non Small Cell Lung Cancer (NSCLC)

This is a Phase I/II, Open Label Study of WSD0922-FU in Combination with Osimertinib for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose disease has progressed with third-generation EGFR-TKI with C797S mutation or is newly diagnosed with CNS metastasis with EGFR Del19 or L858R mutation

Official registry: https://clinicaltrials.gov/study/NCT07206498 · Wayshine Biopharm, Inc. · enrollment listed as 48

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 Osimertinib (Tagrisso®), or WSD0922-FU. The registry lists allocation as randomized. This is a Phase I/II, Open Label Study of WSD0922-FU in Combination with Osimertinib for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose disease has progressed with third-generation EGFR-TKI with C797S mutation or is newly diagnosed with CNS metastasis with EGFR Del19 or L858R mutation

They plan to enroll about 48 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU in Combination With Osimertinib for Patients With Locally Advanced or Metastatic Non- Small Cell Lung Cancer

Interventions: Osimertinib (Tagrisso®), WSD0922-FU

Primary outcome (registry wording): PartA: To evaluate the safety of WSD0922-FU combined with Osimertinib in patients with NSCLC

Who it is for (from inclusion criteria)

Ages 18 Years to any
≥Age 18, gender is not limited;
Locally advanced or metastatic NSCLC confirmed by pathology;
Patients who have been genetically tested to carry EGFR sensitive mutations;
Blood/Tissue samples must be provided for testing;
Must have a minimum life expectancy of \>= 3 months;
At least one measurable tumor lesion according to RECIST version 1.1; ● Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions
Physical Status (ECOG PS) score was 0-1;

Who the registry excludes

Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug
Have previously received more than two EGFR-TKI inhibitors for part A;
Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period
Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drugs
Skin/pressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds
History of severe allergies, or allergies to any active or inactive ingredients of the study drug;
Severe infections requiring intravenous antibiotic infusion or hospitalization at the time of screening; or uncontrollable active infections within 4 weeks before administration;

Public study contact (from the registry)

lily Liu, MD

+8613818880308

lily.liu@wayshinebiopharm.com

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

Sites listed on ClinicalTrials.gov

3 listed

Fujian Cancer Hospital — Fuzhou, Fujian, China (recruiting)
Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (recruiting)
Shanghai East Hospital — Shanghai, China (recruiting)

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FAQ about this NCT record

Is NCT07206498 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 NCT07206498?

Phase 1 / 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 NCT07206498?

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