RecruitingPhase 2NCT06378892

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

A Multicenter Single-arm Phase II Interventional Study to Evaluate the Activity and Safety of 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.


Sponsor

Centro di Riferimento Oncologico - Aviano

Enrollment

45 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Summary

This study aims to evaluate the activity and safety of 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. Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an induction phase of four cycles. Subsequently, patients with response or stability of disease at radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles until progression, unacceptable toxicity, death, or withdrawal of consent.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding standard chemotherapy (platinum plus pemetrexed) to lorlatinib can help patients with a type of lung cancer (ALK-positive non-small cell lung cancer) that has started growing outside the brain while on lorlatinib alone. **You may be eligible if...** - You are 18 or older - You have stage IV non-small cell lung cancer with an ALK gene change - Your cancer is progressing outside the brain while you are on lorlatinib - Your brain metastases (if any) are stable on lorlatinib - You are in good general health (ECOG 0-1) - Your cancer can be measured on scans **You may NOT be eligible if...** - Your cancer is progressing inside the brain - Your overall health is too poor for chemotherapy - You do not have the ALK genetic change in your tumor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLorlatinib

Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an induction phase of four cycles. The choice between Carboplatin or Cisplatin is entrusted to the clinician. Subsequently, patients with response or stability of disease at radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles until progression, unacceptable toxicity, death, or withdrawal of consent.


Locations(9)

Centro di Riferimento Oncologico (CRO) IRCCS

Aviano, Italy

Azienda Ospedaliero-Universitaria Careggi Oncologia Medica

Florence, Italy

Azienda USL Toscana Nord Ovest Oncologia Medica, Ospedale Versilia

Lido di Camaiore, Italy

Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino amadori"

Meldola, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

IOV Istituto Oncologico Veneto IRCCS

Padova, Italy

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

Azienda Ospedaliera di Perugia

Perugia, Italy

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)

Udine, Italy

View Full Details on ClinicalTrials.gov

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NCT06378892