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Tests treatment safety and results for Non Small Cell Lung Cancer (NSCLC)
Official title A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC
ClinicalTrials.gov ID: NCT07206498
What this study is testing
What is Osimertinib (Tagrisso®)?
Osimertinib (Tagrisso®) is an investigational medicine, given as an once-daily, being studied as a potential treatment for non small cell lung cancer (nsclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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;
You likely can't join if
- Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments...
- 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...
- Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drugs.
- Adverse reactions from previous anti-tumor treatments have not recovered to NCI-CTCAE v5.0 grade ≤1 (except for toxicities judged by the researcher...
- Skin/pressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds.
See the full eligibility criteria
- ≥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;
- Have full organ function;
- Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method ;
- people are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily.
- 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.
- Adverse reactions from previous anti-tumor treatments have not recovered to NCI-CTCAE v5.0 grade ≤1 (except for toxicities judged by the researcher to have no safety risks, such as hair loss, grade 2 peripheral...
- 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;
- Known active or suspected autoimmune diseases; or known active ocular diseases (such as active wet age-related macular degeneration, diabetic retinopathy with macular edema);
- Human immunodeficiency virus (HIV) (HIV1/2 antibody) positive, syphilis spirochete antibody positive .
- Patients with interstitial lung disease.
- History of severe cardiovascular diseases.
- Unable to orally swallow medication, or there is a condition that significantly affects gastrointestinal absorption as judged by the researcher; Clinical intervention is required for pleural effusion, ascites (excluding...
- Known alcohol or drug dependence.
- Mental disorders or poor compliance;
- Pregnant or lactating women;
- The investigator believes that the subject has other reasons that make them unsuitable for participating in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.