A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib

Launched by CENTRO DI RIFERIMENTO ONCOLOGICO - AVIANO · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how well a combination of chemotherapy and a targeted treatment called Lorlatinib works for patients with a specific type of lung cancer known as ALK positive Non-Small Cell Lung Cancer (NSCLC). This study focuses on patients whose cancer has progressed outside of the brain while on Lorlatinib treatment. Participants will receive chemotherapy along with Lorlatinib for four cycles. If their condition improves or stays stable, they will then continue with a maintenance phase using a different schedule of pemetrexed and Lorlatinib until their cancer worsens, they experience unacceptable side effects, or they decide to stop participating.

To be eligible for this trial, patients must be at least 18 years old and have a confirmed diagnosis of stage IV ALK positive NSCLC that is worsening outside of the brain. They should also have measurable cancer based on imaging tests and good overall health. Participants will need to agree to take precautions to prevent pregnancy during the study. This trial is currently recruiting participants, and it provides an opportunity for patients to explore a new treatment option that combines chemotherapy with Lorlatinib to potentially help manage their cancer.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Histologically or cytologically confirmed diagnosis of stage IV ALK positive NSCLC.
• • Patients must be in progression extracranially on Lorlatinib; Lorlatinib may be in first- or further-line, without limitations regarding previously received therapies.
• • Age at the time of signing the informed consent at least 18 years.
• • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• • Patients must have measurable disease according to RECIST 1.1 by computed tomography (CT) and magnetic resonance imaging (MRI).
• • Radiologically confirmed multiple extracranial progression on Lorlatinib without progression in the central nervous system (CNS) defined as absence of CNS metastasis or CNS metastasis stable on Lorlatinib and/or stereotactic brain irradiation (SBRT).
• • Adequate organ function (kidney, bone marrow and liver).
• • Estimated life expectancy of at least 3 months irrespective of the diagnosis of ALK+ NSCLC.
• • For women of childbearing potential and males with partners of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 6 months after the last dose of study drugs.
• Key Exclusion Criteria:
• • Known hypersensitivity reaction to one of the compounds or substances used in this protocol.
• • Diagnosis of any secondary malignancy within the last 3 years except for: adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, definitively treated nonmetastatic prostate cancer or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
• • Patients deemed unsuitable by the investigator for treatment of chemo-Lorlatinib combination.
• • Presence of toxicities contraindicating the continuation of therapy with Lorlatinib.
• • Concomitant use of potent CYP3A4/5 inducers.
• • Other inclusion/exclusion criteria may apply.