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NCT05363280 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd Line SCLC
A Phase 2 study of Small-cell Lung Cancer, sponsored by Advenchen Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 6
- Study locations
NCT05363280: Active Phase 2 study of Small-cell Lung Cancer, sponsored by Advenchen Pharmaceuticals.
NCT05363280 is a Phase 2 study of Small-cell Lung Cancer that is active but no longer recruiting, run by Advenchen Pharmaceuticals. The registered enrollment target is 36 participants, below the 232-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (84% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05363280, a Phase 2 study of Small-cell Lung Cancer, is active but no longer recruiting, sponsored by Advenchen Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 6
- Study locations
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 who need ≥2nd line treatment .
Primary Outcome
Determine the Optimal biological dose ( OBD ) via evaluation of dose limiting toxicity (DLT) events to decide the dosing using in expanded cohort
Conditions Studied
Interventions
- DRUG AL8326 low dose group
- DRUG AL8326 middle dose group
- DRUG AL8326 high dose group
Study Locations (6)
Other
- Hospital Universitari Vall d'Hebron - Barcelona
- Hospital Universitario Ramón Y Cajal - Madrid
Alabama
- University of Alabama at Birmingham - Birmingham
Illinois
- Northwestern University - Chicago
Missouri
- Siteman Cancer Center, Washington University - St Louis
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-11-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What the registry record for NCT05363280 still lists
NCT05363280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 232-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which AL8326 low dose group is the first listed.
NCT05363280 lists 6 locations in 5 states (Other, Alabama, Illinois).
Frequently Asked Questions
What is clinical trial NCT05363280 about?
NCT05363280 is a clinical study titled "Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd Line SCLC". 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 who need ≥2nd line treatment .
What is the current status of trial NCT05363280?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2022-11-01. Estimated completion is 2026-12.
What conditions does trial NCT05363280 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer.
What interventions are being tested in trial NCT05363280?
The interventions under investigation include: AL8326 low dose group (DRUG), AL8326 middle dose group (DRUG), AL8326 high dose group (DRUG).
Who is sponsoring clinical trial NCT05363280?
This trial is sponsored by Advenchen Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05363280 being conducted?
This trial has 6 study locations across Alabama, Illinois, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05363280's enrollment target sits among peer trials
36 61st of 79 higher than 18 of 79 other Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small-cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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