ClinicalTrials.gov recorded primary completion on 3 April 2023 for a Phase 3 study of osimertinib, also known as Tagrisso, in EGFR-mutated non-small cell lung cancer. The trial enrolled 587 participants and evaluated osimertinib with chemotherapy against osimertinib alone in first-line treatment.

Background

The study concerned patients with locally advanced or metastatic non-small cell lung cancer involving mutations in the epidermal growth factor receptor gene. Its stated purpose was to determine whether combining oral osimertinib with chemotherapy was more effective than osimertinib alone. The listed chemotherapy interventions were pemetrexed with carboplatin or pemetrexed with cisplatin.

Trial design

This was a Phase 3 study identified as NCT04035486, titled FLAURA2. It enrolled 587 participants with non-small cell lung cancer and was listed as active, not recruiting. The registry described first-line treatment with osimertinib alone or with chemotherapy, including pemetrexed/carboplatin and pemetrexed/cisplatin.

The supplied record did not include primary outcome entries. It did include measurements from safety run-in treatment arms and several statistical analyses, but the analysis records did not identify the corresponding outcome titles.

Key results

The registry-listed analyses included hazard ratios of 0.62 with a 95% confidence interval of 0.49 to 0.79 and p=0.0001, and 0.62 with a 95% confidence interval of 0.48 to 0.80 and p=0.0002. Another hazard-ratio analysis reported 0.90, with a 95% confidence interval of 0.65 to 1.24 and p=0.5238.

Additional analyses reported an odds ratio of 1.61, with a 95% confidence interval of 1.06 to 2.44 and p=0.0261, and a least-square mean difference of -3.36, with a 95% confidence interval of -7.44 to 0.72 and p=0.1067. One exact analysis reported 100.0% of participants with a response or stable disease, with a 95% confidence interval of 88.43% to 100.0%.

Safety run-in measurements listed participant counts ranging from 0 to 9 participants across the carboplatin- and cisplatin-based treatment groups. The supplied data did not define the individual adverse-event categories for those counts.

What this means

The record documents primary completion of a large Phase 3 comparison of osimertinib alone versus osimertinib combined with platinum chemotherapy and pemetrexed in EGFR-mutated non-small cell lung cancer. The available analyses show several comparative estimates, but the supplied record does not link each estimate to a named outcome.

These data therefore support reporting that results were posted for the trial, but they do not establish a specific change to osimertinib’s indication or treatment use from the information provided.

Source

Source: ClinicalTrials.gov, registry record for “A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2),” NCT04035486, with primary completion recorded on 3 April 2023. The record is available at clinicaltrials.gov/study/NCT04035486.