{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":"anaplastic lymphoma kinase-rearranged lung cancer","name":"NCT04292119","nct_id":"NCT04292119","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04292119. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"* The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits.\n* Phase 1 (the dose-finding portion of the study) will follow a standard 3+3 design. Enrollment to the different study arms will occur in parallel.\n\n  * Lorlatinib will be administered orally once daily at a predetermined dose for 28 days\n  * Crizotinib will be administered orally twice daily at a predetermined dose for 28 days\n* Phase II patients will be treated with Lorlatinib and Crizotinib at a dose recommended based on the phase I study.","label":"Lorlatinib and Crizotinib","type":"EXPERIMENTAL"},{"description":"* The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits.\n* The phase I part of the study will follow a standard 3+3 design. Enrollment to the different study arms will occur in parallel.\n\n  * Lorlatinib will be administered orally once daily at a predetermined dose for 28 days\n  * Binimetinib will be administered orally twice daily at a predetermined dose for 28 days.\n* Phase II patients will be treated with Lorlatinib + Binimetinib at a dose recommended based on the phase I study.","label":"Lorlatinib and Binimetinib","type":"EXPERIMENTAL"},{"description":"* The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits.\n* The phase I part of the study will follow a standard 3+3 design. Enrollment to the different study arms will occur in parallel.\n\n  * Lorlatinib will be administered orally once daily at a predetermined dose for 21 days\n  * TNO155 will be administered orally once daily at a predetermined dose for 14 out of 21 days.\n* Phase II patients will be treated with Lorlatinib + TNO155 at a dose recommended based on the phase I study.","label":"Lorlatinib and TNO155","type":"EXPERIMENTAL"}],"collaborators":["Array BioPharma","Pfizer"],"completion_date":{"date":"2023-03-01","type":"ESTIMATED"},"conditions":["Lung Cancer","Anaplastic Lymphoma Kinase Gene Translocation","ROS1 Rearrangement","Relapsed Cancer","MET Amplification","Resistant Cancer","NSCLC"],"enrollment":{"count":96,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Lorlatinib","otherNames":["Lorbrena"],"type":"DRUG"},{"name":"Crizotinib","otherNames":["Xalkori"],"type":"DRUG"},{"name":"Binimetinib","otherNames":["Mektovi"],"type":"DRUG"},{"name":"TNO155","otherNames":[],"type":"DRUG"}],"last_update":"2021-03-10","lead_sponsor":"Massachusetts General Hospital","official_title":"A Phase IB/II Study of Lorlatinib Combinations in Anaplastic Lymphoma Kinase-Rearranged Lung Cancer","overall_status":"UNKNOWN","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2022-12-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Maximum tolerated dose as assessed by CTCAE v5.0. Phase I.","timeFrame":"28 days (binimetinib and crizotinib arm), 21 days (TNO155 arm)"},{"measure":"The objective response rate, including partial and complete responses, as evaluated by RECIST v1.1. Phase II","timeFrame":"24 months"}],"references":[],"start_date":{"date":"2020-05-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Lorlatinib Combinations in Lung Cancer","url":"https://clinicaltrials.gov/study/NCT04292119"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct04292119"}