RightFit
RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well WSD0922-FU works in adults with advanced non-small cell lung cancer. It is for people whose cancer grew during their first treatment with osimertinib and has a change called C797S in the EGFR gene.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old and sign a consent form before any study tests.
  • Have non-small cell lung cancer confirmed by a tissue or cell test.
  • Have cancer that has spread nearby or to other body parts and cannot be cured with surgery or radiation.
  • Have scans showing that cancer grew while taking osimertinib continuously as the first treatment.
  • Have a confirmed change in the EGFR gene.
  • Be fully active or able to do light work, and be expected to live at least 12 weeks.
  • Have at least one tumor area that has not had radiation and will not be used for a tissue sample during the study.
  • Women must have proof that they cannot become pregnant.

Who can't join

  • Used an experimental drug or another cancer drug within 14 days before the first study dose.
  • Still have side effects from past treatment that are more than mild.
  • Have brain problems needing urgent treatment, bleeding inside the skull not caused by a tumor, or seizures needing a change in seizure medicine.
  • Have a severe or uncontrolled illness.
  • Have nausea or vomiting that does not improve with treatment, long-term stomach or bowel disease, trouble swallowing the study drug, or a past surgery removing a large part of the bowel.
  • Have a history of interstitial lung disease, which can cause lung swelling or scarring.
  • Have bone marrow that does not make enough blood cells, or organs that do not work well enough.
  • Are able to become pregnant or father a child.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (8)

CA

FL

MI

NJ

OH

PA

TX

VA