NCT05363280 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
| NCT ID | NCT05363280 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Advenchen Pharmaceuticals, LLC. |
| Condition | Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2022-11-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 .
Eligibility Criteria
Major Inclusion Criteria: 1. Male or female, 18 years of age or older 2. ECOG performance status of 0 or 1 3. Histologically or cytologically confirmed SCLC /NSCLC/RCC 4. Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1 5. Have a life expectancy of at least 3 months Major Exclusion Criteria: 1. Serious, non-healing wound, ulcer or bone fracture 2. Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment 3. Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels 4. 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 congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease 5. Hemoptysis within 3 months prior to enrollment 6. 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 required it. More information available upon request
Contact & Investigator
Saiama Waqar, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT05363280 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05363280 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05363280 currently recruiting?
Yes, NCT05363280 is actively recruiting participants. Contact the research team at shiyings@advenchen.com for enrollment information.
Where is the NCT05363280 trial being conducted?
This trial is being conducted at Birmingham, United States, Weston, United States, Chicago, United States, St Louis, United States and 3 additional locations.
Who is sponsoring the NCT05363280 clinical trial?
NCT05363280 is sponsored by Advenchen Pharmaceuticals, LLC.. The principal investigator is Saiama Waqar, MD at Washington University School of Medicine. The trial plans to enroll 80 participants.
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