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

Korábbi kezelés

• Prior treatment with any systemic anti-cancer therapy for locally advanced NSCLC

Más betegség

• Mixed squamous cell carcinoma, large cell carcinoma, small cell lung cancer.
• Unable to tolerate curative surgery per anaesthesiologist evaluation.History of organ transplant.
• 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;

Egyéb

• Non-resectable stage IB, II, IIIA or selected IIIB NSCLC evaluated by thoracic surgeons.
• Pregnant or lactating, or intending to become pregnant during the study
• 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.

• 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.