375P - Stereotactic radiotherapy (SRT) in combination with aumolertinib to treat intracranial oligometastatic non-small cell lung cancer (NSCLC): A phase II, prospective study

Background

The noval third-generation EGFR-TKI aumolertinib have better initial therapeutic efficacy for intracranial lesions than first-generation TKI. Moreover, Stereotactic radiotherapy (SRT) is highly effective and less toxic for a limited number of intracranial metastases. Research suggested that existing lesions progression were likely to occur before new distant metastasis, so more effective local treatment including SRT after first-line TKIs progression may bring benefits. We aim to investigate the activity and safety of daily aumolertinib followed by SRT in patients with intracranial oligometastatic NSCLC.

Methods

Eligible patients have intracranial oligometastatic disease with EGFR-TKIs sensitive mutations(EGFR-TKIs naive). Patients will receive aumolertinib 110mg daily until intracranial disease progression.Then SRT (32–40Gy total, 8Gy/f) will be given to intracranial oligo-progression disease if possible. Primary endpoint: Intracranial objective response rate, iORR. Secondary endpoint: (1) Intracranial progression-free survival, iPFS/ Intracranial duration of response, iDOR; (RECIST1.1); (2)Cerebral radiation necrosis rate, CRNR/ Overall survival,OS. Toxicities are evaluated according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). This trial is registered with ClinicalTrials. gov, NCT04519983, and is ongoing.

Results

To June 22 2022, a total of 8 patients were enrolled: 3 male and 5 female; The follow up time range from 3 months to 12 months. All the 8 patients were given aumolertinib 110mg daily only. All lesions (both intracranial and extracranial) had partial response(PR) to the treatment. Intracranial objective response rate is 100%. No patient need receive SRT yet. There was no ≥Grade 3 adverse events occurred.

Conclusions

This is the first study that patients with intracranial oligometastatic disease receive aumolertinib daily followed by SRT after intracranial oligo-progression. Aumolertinib showed prelimiary efficacy and good tolerability in intracranial oligometastatic EGFR mutated NSCLC. The study is ongoing and further conclusions are expected to be published in 2023.

Clinical trial identification

NCT04519983.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Hansoh Pharmaceutical Group Company Limited.

Disclosure

H. Zhang: Financial Interests, Personal, Full or part-time Employment: Hansoh Pharma. All other authors have declared no conflicts of interest.