nctId: NCT06378892 id: CRO-2023-78 briefTitle: 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 acronym: ALK-PPL overallStatus: RECRUITING date: 2024-03-15 date: 2028-05 date: 2028-05 date: 2024-04-23 date: 2024-04-23 name: Centro di Riferimento Oncologico - Aviano class: OTHER briefSummary: 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. conditions: Non Small Cell Lung Cancer Metastatic conditions: ALK Gene Mutation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Lorlatinib measure: Compare Progression Free Survival between patients treated with Pemetrexed (PT)/pem-based chemotherapy plus Lorlatinib after Lorlatinib versus retrospective data of 3,2 months for patients treated with PT/pem-based chemotherapy after Lorlatinib. measure: Intracranial Progression Free Survival (PFS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib. measure: Overall survival (OS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib progression measure: Describe the safety of PT/pem-based chemotherapy plus Lorlatinib combination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro di Riferimento Oncologico (CRO) IRCCS status: RECRUITING city: Aviano zip: 33081 country: Italy name: Alessandra Bearz role: CONTACT phone: 0434659294 email: abearz@cro.it lat: 46.07056 lon: 12.59472 facility: Azienda Ospedaliero-Universitaria Careggi Oncologia Medica status: NOT_YET_RECRUITING city: Firenze zip: 50134 country: Italy name: Lorenzo Antonuzzo role: CONTACT phone: 0557947298 email: antonuzzol@aou-careggi.toscana.it lat: 43.77925 lon: 11.24626 facility: Azienda USL Toscana Nord Ovest Oncologia Medica, Ospedale Versilia status: NOT_YET_RECRUITING city: Lido Di Camaiore zip: 55049 country: Italy name: Camerini Andrea role: CONTACT phone: 05846057282 email: andrea.camerini@uslnordovest.toscana.it lat: 43.90012 lon: 10.2269 facility: Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino amadori" status: NOT_YET_RECRUITING city: Meldola zip: 47014 country: Italy name: Delmonte Angelo role: CONTACT phone: 0543739100 email: angelo.delmonte@irst.emr.it lat: 44.12775 lon: 12.0626 facility: Fondazione IRCCS San Gerardo dei Tintori status: NOT_YET_RECRUITING city: Monza zip: 20900 country: Italy name: Cortinovis Diego Luigi role: CONTACT phone: 0392336040 email: diegoluigi.cortinovis@irccs-sangerardo.it lat: 45.58005 lon: 9.27246 facility: IOV Istituto Oncologico Veneto IRCCS status: NOT_YET_RECRUITING city: Padova zip: 35128 country: Italy name: Pasello Giulia role: CONTACT phone: 0498215608 email: giulia.pasello@iov.veneto.it lat: 45.40797 lon: 11.88586 facility: Azienda Ospedaliero-Universitaria di Parma status: NOT_YET_RECRUITING city: Parma zip: 43126 country: Italy name: Tiseo Marcello role: CONTACT phone: 0521702316 email: mtiseo@ao.pr.it lat: 44.79935 lon: 10.32618 facility: Azienda Ospedaliera di Perugia status: NOT_YET_RECRUITING city: Perugia zip: 06129 country: Italy name: Metro Giulio role: CONTACT phone: 0755783695 email: giulio.metro@ospedale.perugia.it lat: 43.1122 lon: 12.38878 facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) status: NOT_YET_RECRUITING city: Udine zip: 33010 country: Italy name: Giacomo Pellizzari role: CONTACT phone: 0432552754 email: giacomo.pelizzari@asufc.sanita.fvg.it lat: 46.0693 lon: 13.23715 hasResults: False