Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Aged ≥18 years
Imaging confirmed, resectable stage IB, II, IIIA or selected IIIB (including T4N2，per AJCC 8th edition)
Histologically/cytologically confirmed lung adenocarcinoma
Documented ALK-rearrangement mutation positive (assessed by a local laboratory)
Disqualifiers
Mixed squamous cell carcinoma, large cell carcinoma, small cell lung cancer.
Prior treatment with any systemic anti-cancer therapy for locally advanced NSCLC
Non-resectable stage IB, II, IIIA or selected IIIB NSCLC evaluated by thoracic surgeons.
Unable to tolerate curative surgery per anaesthesiologist evaluation.History of organ transplant.
Trial design
Treatments tested in this trial
- Lorlatinib 100 mg
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Peking University People's Hospital
Lead sponsor
Hunan Cancer Hospital
Collaborator
Liaoning Cancer Hospital & Institute
Collaborator
Air Force Military Medical University, China
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Source ClinicalTrials.gov