{"entity":{"id":"nct04695925","kind":"trial","name":"Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations","aka":["TOP"],"tldr":"A phase 3 trial of osimertinib, pemetrexed and carboplatin in lung cancer, run by Li Zhang, MD, active but no longer recruiting.","summary":"Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations is a phase 3, randomised interventional study registered as NCT04695925 by Li Zhang, MD, with a registry enrolment figure of 294 participants, started 2021-03-29 and due to reach its primary completion in 2025-11-01. Interventions recorded: Osimertinib; Pemetrexed; Carboplatin. Conditions listed: Non-small Cell Carcinoma; EGFR Gene Mutation. Primary outcome: progression free survival. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed stage IV or recurrent non-squamous non-small cell lung carcinoma with activating EGFR mutations (exon 19 deletion or exon 21 L858R point mutation) and concurrent TP53 mutations;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04695925","url":"https://clinicaltrials.gov/study/NCT04695925"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","platinum"],"targets":[],"drugs":["osimertinib","pemetrexed","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04695925","phase":"3","setting":"A Phase III, Multicentre, Randomized Controlled Study Comparing Osimertinib Monotherapy to Combination Therapy With Osimertinib, Carboplatin and Pemetrexed for Untreated Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer With Concurrent EGFR and TP53 Mutations(TOP)","sponsor":"Li Zhang, MD","enrolled":294,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04695925/","neighbours":{"cancer":[{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"osimertinib","kind":"drug","name":"Osimertinib","route":"/drugs/osimertinib/"},{"id":"pemetrexed","kind":"drug","name":"Pemetrexed","route":"/drugs/pemetrexed/"}],"term":[{"id":"lung-trials-open-today","kind":"term","name":"Lung cancer trials open today (registry snapshot)","route":"/terms/lung-trials-open-today/"}]}}