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NCT06682884

PHASE2

Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

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.

Official title: Phase II, Open-label, Single-arm, Prospective, Multi-center Study to Evaluate the Efficacy and Safety of Lorlatinib as Neoadjuvant Treatment in Surgically Resectable Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer (NEOLORA)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-11-15

Completion Date

2027-05-31

Last Updated

2024-11-12

Healthy Volunteers

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

Inclusion Criteria: * 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) * ECOG PS 0-1 * Patients must be treatment-naive for NSCLC and eligible to receive treatment with Lorlatinb. * Measurable disease, as defined by RECIST v1.1 * Hematology, liver and kidney function are adequate for neoadjuvant therapy. * Cardiopulmonary function suitable for surgical treatment (ECG, echocardiography, pulmonary function or blood gas analysis). * Male participants must be willing to use acceptable methods of contraception. * Female participants of childbearing potential must agree to use acceptable methods of contraception. * Ability to provide written informed consent. Exclusion Criteria: * 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. * Pregnant or lactating, or intending to become pregnant during the study * Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol. * Past medical history of Interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. * A clear past history of neurological or psychiatric disorders, including epilepsy or dementia; * Judgement by investigator that the subject should not participate in the study if the subject is unlikely to comply with the study procedures, restrictions and requirements.