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

Recruiting now · Phase 2

Conditions studied: Non Small Cell Lung Cancer Metastatic, ALK Gene Mutation

In brief

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.

Key facts

Study ID

NCT06378892

Run by

Centro di Riferimento Oncologico - Aviano

People needed

45

Starts

2024-03-15

Expected to finish

2028-05-01

Last updated by the study team

2024-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Centro di Riferimento Oncologico (CRO) IRCCS — Aviano, Italy (enrolling)
• 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

Full record on ClinicalTrials.gov

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