{"commentary":{"count":3,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":3},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"NCT05384626","nct_id":"NCT05384626","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05384626. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Neladalkib (NVL-655) oral daily dosing","label":"Phase 1 dose escalation","type":"EXPERIMENTAL"},{"description":"Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received 1 prior 2nd-generation ALK TKI (ceritinib, alectinib, or brigatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed.","label":"Cohort 2a","type":"EXPERIMENTAL"},{"description":"Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received 2-3 prior ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed.","label":"Cohort 2b","type":"EXPERIMENTAL"},{"description":"Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received lorlatinib as the only prior ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy received prior to lorlatinib is allowed.","label":"Cohort 2c","type":"EXPERIMENTAL"},{"description":"Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who are naïve to ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy is allowed.","label":"Cohort 2d","type":"EXPERIMENTAL"},{"description":"Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, not eligible for other Phase 2 cohorts.","label":"Cohort 2e","type":"EXPERIMENTAL"},{"description":"Patients with other solid tumors harboring an ALK rearrangement or activating ALK mutation, who have received ≥1 prior systemic anticancer therapy, or for whom no satisfactory standard therapy exists.","label":"Cohort 2f","type":"EXPERIMENTAL"},{"description":"Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received ≥1 prior ALK TKI","label":"Cohort G (DDI sub-study)","type":"EXPERIMENTAL"},{"description":"Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received ≥1 prior ALK TKI","label":"Cohort H (DDI sub-study)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2028-01","type":"ESTIMATED"},"conditions":["Locally Advanced Solid Tumor","Metastatic Solid Tumor"],"enrollment":{"count":840,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Neladalkib (NVL-655)","type":"DRUG"},{"name":"Midazolam","type":"DRUG"},{"name":"Repaglinide","type":"DRUG"},{"name":"Itraconazole","type":"DRUG"}],"last_update":"2026-05-27","lead_sponsor":"Nuvalent Inc.","official_title":"A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-12","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Dose limiting toxicities (DLTs) (Phase 1)","timeFrame":"Within the first 21 days of the first neladalkib (NVL-655) dose"},{"measure":"Recommended Phase 2 Dose (RP2D) (Phase 1)","timeFrame":"Within 21 days of last patient dosed during escalation"},{"measure":"Objective Response Rate (ORR) (Phase 2)","timeFrame":"2-3 years after first patient dosed."},{"measure":"Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 1)","timeFrame":"Approximately 3 years"},{"measure":"Area under the curve of repaglinide (Phase 2 DDI sub-study)","timeFrame":"Pre-dose and up to 24 hours post-dose"},{"measure":"Area under the curve of midazolam (Phase 2 DDI sub-study)","timeFrame":"Pre-dose and up to 24 hours post-dose"},{"measure":"Area under the curve of neladalkib (NVL-655) (Phase 2 DDI sub-study)","timeFrame":"Pre-dose and up to 24 hours post-dose"}],"references":[],"start_date":{"date":"2022-06-09","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)","url":"https://clinicaltrials.gov/study/NCT05384626"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct05384626"}