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