Trial results for osimertinib (Tagrisso) in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation were posted on ClinicalTrials.gov on 2025-02-11. The Phase 2 study reported an objective response rate of 0 participants, indicating no objective responses were observed in the trial.
Background
Osimertinib is a medication studied for locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose disease has progressed on standard chemotherapy. This particular trial focused on NSCLC patients with an EGFR exon 20 insertion mutation.
Trial design
This completed Phase 2, single-arm, non-randomized multicenter study (NCT03414814) investigated osimertinib in 15 enrolled participants. The study focused on patients with Locally Advanced or Metastatic NSCLC who had an EGFR exon 20 insertion mutation and whose disease had progressed on standard chemotherapy. Participants received osimertinib 80 mg.
Key results
The trial reported the following key measurements:
- The Objective Response Rate was 0 participants.
- Median Progression-free Survival was 3.8 months (95% Confidence Interval).
- Median Overall Survival was 6.5 months (95% Confidence Interval).
- Serious Adverse Events were reported in 1 case, 1 case, 2 cases, 1 case, 1 case, 1 case, and 1 case.
What this means
The results from this Phase 2 study indicate that osimertinib did not achieve an objective response in the enrolled population of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation whose disease had progressed on standard chemotherapy. With an objective response rate of 0 participants, the findings suggest that osimertinib may not be an effective treatment option for this specific patient group under the studied conditions. The reported median progression-free survival of 3.8 months and median overall survival of 6.5 months further characterize the limited efficacy observed in this trial.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03414814, titled "Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation," were posted on 2025-02-11 on clinicaltrials.gov.