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
Condition(s) studied
Investigational drug(s) / intervention(s)
AL8326 40 mg: Taken AL3826 at 40mg QD orally
AL8326 60 mg: Taken AL3826 at 60mg QD orally
AL8326 80 mg--stopped: Taken AL3826 at 80 mg QD orally
Study 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
Primary outcome measure(s)
- Optimal biological dose ( OBD ) — 12 months
Determine the Optimal biological dose ( OBD ) via evaluation of dose limiting toxicity (DLT) events to decide the dosing using in expanded cohort - Objective Response Rates (ORR) — 12 month
Evaluate the efficacy among 3 different dosing groups - ORR evaluation for NSCLC and RCC — 24 month
ORR evaluation for NSCLC and RCC
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| Cleveland Clinic Florida | Weston | Florida | Withdrawn |
| Northwestern University | Chicago | Illinois | Completed |
| Siteman Cancer Center, Washington University | St Louis | Missouri | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital Universitario Ramón Y Cajal | Madrid | Spain | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05363280 on ClinicalTrials.gov ↗ ← All trials in Spain