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Brief Title: 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
Official Title: 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.
Study ID: NCT06378892
Brief 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.
Detailed Description: This is a multicentre, phase II, interventional, prospective, single arm, non-randomised study focused on ALK+ NSCLC with extracranial progression on Lorlatinib.Treatment phase include the period starting from cycle 1 day 1 visit to discontinuation of study therapy and consists of two phases: induction phase and maintenance phase. 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Centro di Riferimento Oncologico (CRO) IRCCS, Aviano, , Italy
Azienda Ospedaliero-Universitaria Careggi Oncologia Medica, Firenze, , 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