{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"ALKOVE-1","nct_id":"NCT05384626","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=alkove-1-nct05384626. The price is an estimate of verified HCP statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified HCP statements, estimated at 14 per indexed commentary source"},"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)","otherNames":[],"type":"DRUG"},{"name":"Midazolam","otherNames":[],"type":"DRUG"},{"name":"Repaglinide","otherNames":[],"type":"DRUG"},{"name":"Itraconazole","otherNames":[],"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":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/alkove-1-nct05384626"}