{"commentary":{"count":34,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":20,"youtube":10,"podcast":4},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04302025\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NAUTIKA1","nct_id":"NCT04302025","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nautika1-nct04302025. 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":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"NAUTIKA1","arms":[{"description":"Participants will receive up to 8 weeks of alectinib neoadjuvant treatment before undergoing surgical resection per standard of care (SOC). All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with alectinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of alectinib.\n\nEnrolment Closed.","label":"ALK Cohort (Enrolment Closed)","type":"EXPERIMENTAL"},{"description":"Participants will receive up to 8 weeks of entrectinib neoadjuvant treatment before undergoing surgical resection per SOC. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with entrectinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of entrectinib.\n\nEnrolment Closed.","label":"ROS 1 Cohort (Enrolment Closed)","type":"EXPERIMENTAL"},{"description":"Participants will receive up to 8 weeks of entrectinib neoadjuvant treatment before undergoing surgical resection per SOC. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with entrectinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of entrectinib.\n\nEnrolment Closed.","label":"NTRK Cohort (Enrolment Closed)","type":"EXPERIMENTAL"},{"description":"Participants will receive up to 8 weeks of vemurafenib plus cobimetinib neoadjuvant treatment before undergoing surgical resection per SOC. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with vemurafenib plus cobimetinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of of vemurafenib plus cobimetinib.\n\nCohort closed.","label":"BRAF Cohort (No Participants Enrolled, Cohort Closed)","type":"EXPERIMENTAL"},{"description":"Participants will receive up to 8 weeks of pralsetinib neoadjuvant treatment before undergoing surgical resection per SOC. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with pralsetinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of pralsetinib.\n\nCohort closed.","label":"RET Cohort (Cohort closed)","type":"EXPERIMENTAL"},{"description":"Participants with positive programmed death-ligand 1 (PD-L1) in ≥1% tumor cells will receive 4 cycles of atezolizumab neoadjuvant treatment. During neoadjuvant Cycle 1 of atezolizumab, participants will also receive low-dose stereotactic body radiation therapy (SBRT) (8 gray \\[Gy\\] X 3). Adjuvant treatment consists of SOC treatment as determined by the investigator, per National Comprehensive Cancer Network (NCCN) guidelines.\n\nEnrolment Closed.","label":"PD-L1 Cohort (Enrolment Closed)","type":"EXPERIMENTAL"},{"description":"Participants will receive up to 8 weeks of divarasib as neoadjuvant treatment before undergoing surgical resection per SOC. PD-L1 negative participants whose tumors have pathological response or lack radiographic progression will be have the option of continuing divarasib alone for up to 3 years or 1-4 cycles of SOC chemotherapy followed by divarasib for 3 years as adjuvant therapy. For participants who test positive PD-L1, they will have the option to receive 1-4 cycles of SOC chemotherapy followed by atezolizumab for up to 16 cycles or SOC alone.","label":"KRAS G12C Cohort","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2030-05-30","type":"ESTIMATED"},"conditions":["Non-small Cell Lung Cancer"],"enrollment":{"count":99,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Alectinib","type":"DRUG"},{"name":"Entrectinib","type":"DRUG"},{"name":"Vemurafenib","type":"DRUG"},{"name":"Cobimetinib","type":"DRUG"},{"name":"Pralsetinib","type":"DRUG"},{"name":"Atezolizumab","type":"DRUG"},{"name":"SBRT","type":"DRUG"},{"name":"Resection","type":"PROCEDURE"},{"name":"Chemotherapy","type":"DRUG"},{"name":"Divarasib","type":"DRUG"}],"last_update":"2026-09-10","lead_sponsor":"Genentech, Inc.","official_title":"NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer","overall_status":"RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2026-11-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Tyrosine Kinase Inhibitor (TKI) Cohort: Proportion of Participants With Major Pathologic Response (MPR)","timeFrame":"After surgical resection (approximately study Week 8)"},{"measure":"Checkpoint Inhibitor (CPI) Cohort: Pathological Complete Response (pCR)","timeFrame":"After surgical resection (approximately study Week 8)"},{"measure":"KRAS G12C Cohort: Percentage of Participants With 3-5 Grade Adverse Events (AEs)","timeFrame":"After surgical resection (approximately study Week 8)"},{"measure":"KRAS G12C Cohort: Percentage of Participants Without Delays of Surgery due to Treatment-related AEs as Reported by the Investigator","timeFrame":"After surgical resection (approximately study Week 8)"}],"references":[],"start_date":{"date":"2020-11-06","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)","url":"https://clinicaltrials.gov/study/NCT04302025"},"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/nautika1-nct04302025"}