Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer
NCT06682884 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2024-11-12
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.
Conditions
- Neoadjuvant Non-Small Cell Lung Cancer
Interventions
- DRUG
-
Lorlatinib 100 mg
Eligible patients will be registered to receive oral lorlatinib 100mg qd for 6-8 weeks each during the neoadjuvant therapy phase
Sponsors & Collaborators
-
Hunan Cancer Hospital
collaborator OTHER -
Liaoning Cancer Hospital & Institute
collaborator OTHER -
Air Force Military Medical University, China
collaborator OTHER -
Second Affiliated Hospital, School of Medicine, Zhejiang University
collaborator OTHER -
Peking University People's Hospital
lead OTHER
Principal Investigators
-
Fan F Yang, M.D. · Peking University People's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-15
- Primary Completion
- 2026-04-30
- Completion
- 2027-05-31
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