# Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations

Source: https://onco.cc/trials/nct04695925/  
OnCo record `nct04695925` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-25
- Also known as: TOP
- Tags: ctgov-ingest; lung-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT04695925: https://clinicaltrials.gov/study/NCT04695925

## Connected records

- cancers: [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Platinum agents](https://onco.cc/technologies/platinum/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Osimertinib](https://onco.cc/drugs/osimertinib/), [Pemetrexed](https://onco.cc/drugs/pemetrexed/)
- terms: [Lung cancer trials open today (registry snapshot)](https://onco.cc/terms/lung-trials-open-today/)

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