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New treatment option for Small Cell Lung Cancer
Official title Phase 2 Study for the Patient, Who Has Diagnosed With Small Cell Lung Cancer (SCLC) or Non Small Cell Lung Cancer (NSCLC) or Renal Cell Carcinoma (RCC) and Finished the First Line Stand Treatment , Need More Treatment
ClinicalTrials.gov ID: NCT05363280
What this study is testing
What is AL8326 40 mg?
AL8326 40 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for small cell lung cancer.
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 trial is a Phase II trial designed to evaluate the safety and efficacy of using oral AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , to recurrent, advanced, or metastatic small cell lung cancer (SCLC) patients , Non-Small Cell Lung (NSCLC) and Renal Cell Carcinoma patients who need ≥2nd line treatment .
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Major
- Male or female, 18 years of age or older
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed SCLC /NSCLC/RCC
- Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1
You likely can't join if
- Serious, non-healing wound, ulcer or bone fracture
- Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment
- Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major...
- Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to...
- Hemoptysis within 3 months prior to enrollment
- Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless...
See the full eligibility criteria
- Major
- Male or female, 18 years of age or older
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed SCLC /NSCLC/RCC
- Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1
- Have a life expectancy of at least 3 months Major
- Serious, non-healing wound, ulcer or bone fracture
- Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment
- Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
- Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater...
- Hemoptysis within 3 months prior to enrollment
- Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Weston, Florida, United States
- Chicago, Illinois, United States
- St Louis, Missouri, United States
- Cleveland, Ohio, United States
- Barcelona, Spain
- Madrid, Spain
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 Birmingham, Alabama, United States; Weston, Florida, United States; Chicago, Illinois, United States; St Louis, Missouri, United States; Cleveland, Ohio, United States; Barcelona, Spain and 1 more location(s). 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.