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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06682884 on ClinicalTrials.gov