# First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations

Source: https://onco.cc/key-papers/paper-nct05668988-n-engl-j-med-2026/  
OnCo record `paper-nct05668988-n-engl-j-med-2026` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Published report from the WU-KONG28 trial registered as NCT05668988, in New England Journal of Medicine (2026), chosen as the most cited paper whose own text cites the registry id.

## Summary

Background: Sunvozertinib received accelerated approval for use in later lines of therapy for patients with advanced non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor ( EGFR) exon 20 insertion mutations. Data are needed on the efficacy and safety of sunvozertinib as a first-line treatment for NSCLC.

Methods: In this phase 3, international trial, we randomly assigned, in a 1:1 ratio, patients with advanced nonsquamous NSCLC with EGFR exon 20 insertions to receive sunvozertinib or chemotherapy (carboplatin-pemetrexed). The primary end point was progression-free survival as assessed by blinded independent central review. Crossover to the sunvozertinib group was allowed after disease progression was confirmed. Secondary end points included overall survival, investigator-assessed progression-free survival, objective response (complete or partial response), change in tumor size, and duration of response.

Results: A total of 324 patients were randomly assigned to receive sunvozertinib (163 patients) or chemotherapy (161 patients). Treatment with sunvozertinib led to significantly longer median progression-free survival than chemotherapy (10.3 vs. 7.5 months; hazard ratio for disease progression or death, 0.65; 95% confidence interval, 0.50 to 0.85; P<0.001). At 12 months, progression-free survival was reported in 46.1% of the patients in the sunvozertinib group and in 26.7% of those in the chemotherapy group; the data for overall survival were immature (38.9% maturity). The percentage of patients with an objective response was 58.9% in the sunvozertinib group and 31.1% in the chemotherapy group; the median best percentage change in tumor size was -42.1% and -24.7% respectively, and the median duration of response was 11.2 and 7.1 months. Grade 3 or higher adverse events were reported in 75.5% of the patients in the sunvozertinib group and in 56.7% of those in the chemotherapy group. In the sunvozertinib group, the most common adverse events of grade 3 or higher included increased serum creatine kinase levels, diarrhea, and anemia. No deaths were attributed to adverse events considered by the investigators to be related to sunvozertinib.

Conclusions: The efficacy of sunvozertinib was superior to that of chemotherapy as first-line treatment for advanced NSCLC with EGFR exon 20 insertions. (Funded by Dizal Pharmaceuticals; WU-KONG28 ClinicalTrials.gov number, NCT05668988.).

Indexed on Europe PMC as PubMed record 42212913 (DOI 10.1056/nejmoa2604461). Its abstract cites the registry id NCT05668988, which is how it was matched to this trial; no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: New England Journal of Medicine
- Year: 2026
- DOI: 10.1056/nejmoa2604461
- Authors: Zhou C, Greillier L, Liu G, et al.
- What it means: This is the paper Europe PMC returns for registry id NCT05668988 with the most citations, so it is the natural first reading for anyone following the WU-KONG28 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
- Caveats: Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.

## Sources

- N Engl J Med 2026: https://doi.org/10.1056/nejmoa2604461
- PubMed: https://pubmed.ncbi.nlm.nih.gov/42212913/
- Europe PMC: https://europepmc.org/article/MED/42212913
- ClinicalTrials.gov NCT05668988: https://clinicaltrials.gov/study/NCT05668988

## Connected records

- trials: [A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)](https://onco.cc/trials/nct05668988/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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