{"preliminary_commentary":{"by_channel":{"youtube":68,"x_thread":66,"podcast":55,"x_video":1},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05388669\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"PALOMA-3","nct_id":"NCT05388669","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=paloma-3-nct05388669. The price is an estimate of verified 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"PALOMA-3","arms":[{"description":"Lazertinib 240 milligrams (mg) will be administered orally once daily. Participants will receive amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 mg/ 2240 mg depending on the body weight by manual injection. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the long-term extension (LTE) Phase.","label":"Arm A: Lazertinib with Amivantamab SC-CF","type":"EXPERIMENTAL"},{"description":"Lazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the LTE Phase.","label":"Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-06-30","type":"ESTIMATED"},"conditions":["Advanced or Metastatic Non-small Cell Lung Cancer"],"enrollment":{"count":418,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Lazertinib","otherNames":["JNJ-73841937","YH25448"],"type":"DRUG"},{"name":"Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)","otherNames":["JNJ-61186372"],"type":"DRUG"},{"name":"Amivantamab Intravenous","otherNames":["JNJ-61186372"],"type":"DRUG"}],"last_update":"2026-09-28","lead_sponsor":"Janssen Research & Development, LLC","official_title":"A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2024-01-03","type":"ACTUAL"},"primary_outcomes":[{"measure":"For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State","timeFrame":"Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)"},{"measure":"For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab","timeFrame":"Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)"},{"measure":"Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2","timeFrame":"Cycle 2: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hours (hrs) post-dose on Day 1; Arm B: pre-infusion, end of infusion (EOI)+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1"}],"references":[{"citation":"Leighl NB, Passaro A, Akamatsu H, Spira AI, Nguyen D, Qin A, Schuchard J, Gamil M, Baig M, Alexander M. Plain language summary of subcutaneous vs IV amivantamab plus lazertinib in EGFR-altered non-small-cell lung cancer. Future Oncol. 2026 Aug 24:1-17. doi: 10.1080/14796694.2026.2709936. Online ahead of print.","pmid":"42635093","type":"DERIVED"},{"citation":"Leighl NB, Akamatsu H, Lim SM, Cheng Y, Minchom AR, Marmarelis ME, Sanborn RE, Chih-Hsin Yang J, Liu B, John T, Massuti B, Spira AI, Lee SH, Wang J, Li J, Liu C, Novello S, Kondo M, Tamiya M, Korbenfeld E, Moskovitz M, Han JY, Alexander M, Joshi R, Felip E, Voon PJ, Danchaivijitr P, Hsu PC, Silva Melo Cruz FJ, Wehler T, Greillier L, Teixeira E, Nguyen D, Sabari JK, Qin A, Kowalski D, Sendur MAN, Xie J, Ghosh D, Alhadab A, Haddish-Berhane N, Clemens PL, Lorenzini P, Verheijen RB, Gamil M, Bauml JM, Baig M, Passaro A; PALOMA-3 Investigators. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. J Clin Oncol. 2024 Oct 20;42(30):3593-3605. doi: 10.1200/JCO.24.01001. Epub 2024 Jun 10.","pmid":"38857463","type":"DERIVED"}],"start_date":{"date":"2022-08-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT05388669"},"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/paloma-3-nct05388669"}