drugset / Trial / NCT06682884
Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer
Phase 2
Not yet recruiting
25 enrolled
Peking University People's Hospital
Air Force Military Medical University, China · collabHunan Cancer Hospital · collabLiaoning Cancer Hospital & Institute · collabSecond Affiliated Hospital, School of Medicine, Zhejiang University · collab
NaSingle-groupOpen-labelTreatment
Summary
This project was designed To explore the pathological complete response (pCR) of lorlatinib as neoadjuvant treatment. Twenty-five patients will be involved in this study. These patients will receive lorlatinib neoadjuvant therapy for 6-8 weeks (determined by clinicians' decision based on clinical practice) and then underwent surgery. Previous small-sample clinical studies on ALK inhibitors as neoadjuvant therapy in resectable NSCLC have shown promising outcomes including MPR and pCR, supporting the potential of ALK TKIs in this setting.
Timeline
- Start
- 2024-11-15
- Primary completion
- 2026-04-30
- Completion
- 2027-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lorlatinib | Small molecule | 100 mg | Oral |